Dose Ranging Study of Pazopanib to Treat Neovascular Age-... | NCT01134055 | Trialant
NCT01134055
Sponsor
GlaxoSmithKline
Status
Completed
Last Update Posted
Jan 8, 2018Actual
Enrollment
510Actual
Phase
Phase 2
Conditions
Macular Degeneration
Interventions
pazopanib eye drops
placebo
ranibizumab intravitreal injection
Countries
United States
Australia
Belgium
Canada
Denmark
Germany
Italy
Japan
Sweden
Protocol Section
Identification Module
NCT ID
NCT01134055
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
110852
Secondary IDs
Not provided
Brief Title
Dose Ranging Study of Pazopanib to Treat Neovascular Age-Related Macular Degeneration
Official Title
MD7110852, A Phase 2b Dose-Ranging Study of Pazopanib Eye Drops Versus Ranibizumab Intravitreal Injections for the Treatment of Neovascular Age-Related Macular Degeneration
Acronym
Not provided
Organization
GlaxoSmithKlineINDUSTRY
Status Module
Record Verification Date
Dec 2017
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Jun 1, 2010Actual
Primary Completion Date
Oct 1, 2012Actual
Completion Date
Oct 1, 2012Actual
First Submitted Date
May 27, 2010
First Submission Date that Met QC Criteria
May 27, 2010
First Posted Date
May 31, 2010Estimated
Results Waived
Not provided
Results First Submitted Date
Aug 11, 2017
Results First Submitted that Met QC Criteria
Dec 7, 2017
Results First Posted Date
Jan 8, 2018Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Apr 11, 2013
Certification/Extension First Submitted that Passed QC Review
Apr 11, 2013
Certification/Extension First Posted Date
Apr 18, 2013Estimated
Last Update Submitted Date
Dec 7, 2017
Last Update Posted Date
Jan 8, 2018Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
GlaxoSmithKlineINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The purpose of this study is to determine the safety and efficacy of different dosage regimens of pazopanib eye drops for the treatment of neovascular age-related macular degeneration.
Detailed Description
MD7110852 is a Phase 2b dose-ranging study designed to demonstrate the 1 year efficacy and safety of pazopanib eye drops for the treatment of neovascular age related macular degeneration (AMD) in subjects whose disease is currently managed with anti-VEGF (vascular endothelial growth factor) injection therapy. Eye drop regimens are double-masked with placebo eye drops and will have access to open-label ranibizumab intravitreal (IVT) injection if needed. The ranibizumab IVT injection every 4 weeks control arm is open-label.
Conditions Module
Conditions
Macular Degeneration
Keywords
ranibizumab
wet AMD
MD7110852
age related macular degeneration
age-related macular degeneration
macular degeneration
pazopanib
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
510Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
investigational arm 1
Experimental
5 mg/mL pazopanib eye drops TID with allowance for as-needed ranibizumab injection
Drug: pazopanib eye drops
investigational arm 2
Experimental
5 mg/mL pazopanib eye drops QID with allowance for as-needed ranibizumab injection
Drug: pazopanib eye drops
investigational arm 3
Experimental
10 mg/mL pazopanib eye drops BID with allowance for as-needed ranibizumab injection
Drug: pazopanib eye drops
investigational arm 4
Experimental
10 mg/mL pazopanib eye drops TID with allowance for as-needed ranibizumab injection
Drug: pazopanib eye drops
investigational arm 5
Experimental
10 mg/mL pazopanib eye drops QID with allowance for as-needed ranibizumab injection
Drug: pazopanib eye drops
placebo control arm
Placebo Comparator
Interventions
Name
Type
Description
Arm Group Labels
Other Names
pazopanib eye drops
Drug
A tyrosine kinase inhibitor of multiple receptors including vascular endothelial growth factor receptors and platelet-derived growth factor receptors.
investigational arm 1
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Change From Baseline in Best-corrected Visual Acuity (BCVA) as Measured by the Number of Letters Read on the Early Treatment of Diabetic Retinopathy Study (ETDRS) Grading Charts at a Starting Distance of 4 Meters at Week 52
BCVA was measured in the study eye using the ETDRS grading charts starting at a test distance of 4 meters. The ETDRS grading chart was of at least 24 to 78 letters. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved. There were seven cut off points in change from baseline visual acuity on ETDRS grading chart which are, 15 to 29, 10 to 14, 5 to 9, -4 to 4, -5 to -9, -10 to -14 and -15 to -29 letters. The change from baseline was calculated by subtracting the baseline values from the individual post-randomization values. If either the baseline or post-randomization value was missing, the change from baseline was set to missing as well. Day 1 values are considered as Baseline in this study.
Day 1 and 52 weeks
Secondary Outcomes
Measure
Description
Time Frame
Percentage of Ranibizumab Re-injections Received Over 28 and 52 Weeks
The investigator interpreted each Week 4 to Week 52 Optical coherence tomography (OCT) scan, BCVA score, and available Fluorescein angiography (FA)/Fundus photography (FP) and re-injected if one or more criteria were met. The criteria were: Evidence of Intraretinal (IR) (with or without cysts) fluid or Subretinal (SR) fluid, a serous retinal pigment epithelial detachment, a notable decline in Visual Acuity, new SR or IR macular hemorrhage that the investigator judges is associated with Choroidal neovascularization, increased lesion size on FA relative to the last angiogram as judged by the investigator or leakage on FA that the investigator judges would benefit from re-injection. Injection rate over 52 weeks was computed by taking the number of injections received divided by the number of visits for the participant. Likewise for 28 weeks it was estimated as the number of post baseline injections received divided by the number of post baseline visits at or before the week 28 visit.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Men and women aged ≥50 years.
Active subfoveal choroidal neovascularization (CNV) lesion secondary to AMD in study eye: Total lesion area ≤12 disc areas with CNV ≥50% total lesion area.
Anti-Vascular endothelial growth factor (VEGF) intravitreal injection experienced and in need of re-treatment.
Best-corrected visual acuity of at least 24 letters (equates to approximately 20/320 Snellen equivalents or better).
Exclusion Criteria:
Prior ocular investigational drug/device for choroidal neovascularization, photodynamic therapy, radiation, subfoveal or juxtafoveal focal laser photocoagulation.
Prior failure to anti-VEGF intravitreal injection therapy.
Recent ocular investigational drug/device for non-CNV condition.
Prior ocular surgeries (vitrectomy, scleral buckle, or glaucoma filtering/shunt surgery). Cataract surgery permitted if ≥3 months and has posterior chamber intraocular lens.
Center-fovea involvement of any of the following: fibrosis, atrophy, serous retinal pigment epithelial detachment, or retinal pigment epithelial tear.
CNV in either eye due to other causes.
Clinical evidence of diabetic retinopathy or diabetic macular edema.
Recent myocardial infarction or cerebrovascular accident.
Uncontrolled hypertension in spite of antihypertensive medications.
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
50 Years
Maximum Age
Not provided
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
GSK Clinical Trials
GlaxoSmithKline
Study Director
Locations
Facility
Status
City
State
ZIP
Country
Contacts
GSK Investigational Site
Peoria
Arizona
85381
United States
GSK Investigational Site
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
No data available
No data is available for this block.
Results Section
Participant Flow Module
Pre-assignment Details
A total of 510 participants were randomized for the study. After a 1-2 week screening period, participants entered a 52-week treatment period. There were 449 screen failures in this study.
Recruitment Details
This was a multicenter, randomized, parallel-group, double-masked eye drops, and active-controlled study from 01 June 2010 to 05 October 2012. The study was conducted at 77 sites in 9 countries from North America, Europe, Australia and Japan.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Placebo Control Arm QID
Only the study eye (one eye) per participant enrolled in the study received Placebo QID. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week treatment period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
Placebo eye drops QID with allowance for as-needed ranibizumab injection
Drug: placebo
active open-label control arm
Active Comparator
Ranibizumab intravitreal injection every 4 weeks
Biological: ranibizumab intravitreal injection
investigational arm 2
investigational arm 3
investigational arm 4
investigational arm 5
placebo
Drug
placebo eye drops
placebo control arm
ranibizumab intravitreal injection
Biological
Humanized recombinant monoclonal antibody fragment targeted against human vascular endothelial growth factor A
active open-label control arm
Up to 52 weeks
Number of Participants With BCVA Over Time
BCVA was measured in the study eye using the ETDRS grading charts starting at a test distance of 4 meters. The ETDRS grading chart was of at least 24 to 78 letters. There were seven cut off points in change from baseline visual acuity on ETDRS grading chart which are, 15 to 29, 10 to 14, 5 to 9, -4 to 4, -5 to -9, -10 to -14 and -15 to -29 letters.
Up to Week 52
Number of Participants Analyzed for Visual Acuity (VA) Response Over Time
VA was measured in the study eye using the ETDRS grading charts starting at a test distance of 4 meters.The ETDRS grading chart was of at least 24 to 78 letters. There were seven cut off points in change from baseline visual acuity on ETDRS grading chart which are, 15 to 29, 10 to 14, 5 to 9, -4 to 4, -5 to -9, -10 to -14 and -15 to -29 letters. This outcome measure contains the number of participants who were analyzed for VA response.
Week 52
Change From Baseline in Center Point Thickness (CPT) Over Time
CPT was the inner limiting membrane to the beginning of the retinal pigment epithelium (RPE) inclusive of SR fluid. The outer boundary included the outer segment of the photoreceptors and not included the RPE. The change from baseline was calculated by subtracting the baseline values from the individual post-randomization values. If either the baseline or post-randomization value was missing, the change from baseline was set to missing as well. Day 1 values are considered as Baseline in this study. In amendment 3, inclusion criterion number 5 was revised to remove the required quantitative OCT component. OCT examination was used to supplement FA findings and provided qualitative (presence of SR and/or IR fluid) and quantitative (a CPT that is at least 250 microns) evidence of an active subfoveal lesion. Hence data for pre and post amendment have been provided separately.
Baseline and Week 52
Number of Participants That Met Criteria for Re-injection
The investigator interpreted each Week 4 to Week 52 Optical coherence tomography (OCT) scan, BCVA score, and available Fluorescein angiography (FA)/Fundus photography (FP) and re-injected if one or more criteria were met. The criteria were: Evidence of Intraretinal (IR) (with or without cysts) fluid or Subretinal (SR) fluid, a serous retinal pigment epithelial detachment, a notable decline in Visual Acuity, new SR or IR macular hemorrhage that the investigator judges is associated with Choroidal neovascularization, increased lesion size on FA relative to the last angiogram as judged by the investigator or leakage on FA that the investigator judges would benefit from re-injection.
Up to Week 52
Change From Baseline in the Area of Choroidal Neovascularisation (CNV)
Choroidal neovascularisation is progressive worsening of vision that can cause hemorrhage and exudation, and finally disciform scarring and retinal atrophy. The change from baseline was calculated by subtracting the baseline values from the individual post-randomization values. If either the baseline or post-randomization value was missing, the change from baseline was set to missing as well. Day 1 values are considered as Baseline in this study.
Day 1, Week 28 and Week 52
Change From Baseline in the Area of the CNV Lesion Complex (i.e. CNV, Blood, PED, and Fibrosis)
CNV is progressive worsening of vision that can cause hemorrhage and exudation, and finally disciform scarring and retinal atrophy. The change from baseline was calculated by subtracting the baseline values from the individual post-randomization values. If either the baseline or post-randomization value was missing, the change from baseline was set to missing as well. Day 1 values are considered as Baseline in this study.
Day 1, Week 28 and Week 52
Change From Baseline in the Area of Fluorescein Leakage
Fluorescein angiograms was performed at the Screening, Week 12, Week 28, and Week 52 Visits. All images, including any that were performed at the investigator's medical discretion, were transferred to the FPRC. Fluorescein was injected intravenously according to usual clinic procedures. Dose response was also examined under different aspects of re-injection, such as time to first injection, the percentage of participants that required an injection by Week 28, as well as the estimation of the probability of reinjection. FA assessments of area of fluorescein leakage, CNV area and area of CNV lesion complex were also examined for dose differentiation.
Day 1, Week 28 and Week 52
Change in Area of Serous Sensory Retinal Detachment (SSRD)
This is an Optical coherence tomography (OCT) parameter used to manually measure thickness along any scan. OCT was performed at week 28 and week 52.
Day 1, Week 28 and Week 52
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is any untoward medical occurrence that, at any dose results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect.
Up to 52 Weeks
Summary of Potentially Clinically Important Findings for Ophthalmic Examinations
Opthalmicexaminations were done on Ocular alignment and motility, pupillary function, and visual fields by confrontation. Slit-lamp biomicroscopic examination of the anterior segment structure was performed. Fundus slit-lamp biomicroscopic examination, including use of accessory diagnostic lenses, to view the vitreous, retina (including posterior pole and periphery), macula, vasculature, and optic nerve was also performed. These examinations were performed on the study eye (SE) and the Fellow eye (FE). Participants with abnormal findings are listed here.
Up to Week 52
Summary of Intraocular Pressure Exam Findings
Intraocular pressure (IOP) measurement was done with Goldmann tonometer. Intraocular pressure was measured prior to dilating the pupil and, to account for diurnal variation, at approximately the same time of day for every visit.
Up to week 52
Number of Participants With Vital Sign Values Outside of Clinical Concern Range
Vital signs including systolic and diastolic blood pressure and heart rate were measured throughout the study. Number of participants with vital signs outside of clinical concern Range were summarized. 'High' denotes above normal range and 'Low' denotes below normal range for all the categories. The potential clinical importance ranges (low and high) of the vital sign parameters were for systolic blood pressure (<85 and >160 millimeter of mercury [mmHg]), diastolic blood pressure (<45 and >100 mmHg) and heart rate (<40 and >110 beats per minute). Only those parameters for which at least one value of potential clinical importance was reported are summarized. The number of participants with potential clinical important vital parameter findings at any visit were reported.
Up to Week 52
Summary of Abnormal Electrocardiogram (ECG) Findings
12-Lead ECGs were performed in triplicate and were obtained on Weeks 4 to Week 28 and Week 52. The on-treatment ECGs were used to ascertain any risk of QTc interval prolongation at extremely low pazopanib exposures compared to what was routinely observed in participants with cancer. The on-treatment ECG data collected from participants assigned to one of the control arms also provided ECG background rate data for participants not exposed to pazopanib. Participants with Clinically significant abnormal ECGs are included here.
Week 4, Week 28, Week 44 and Week 52
Summary of Hematology and Clinical Chemistry Parameters Data of Clinical Concern
The Laboratory Parameters included Alanine Amino Transferase (ALT), Albumin, Alkaline Phosphatase, Aspartate Amino Transferase (AST), Calcium, Bicarbonate, Creatinine, Glucose, Hemoglobin, Lymphocytes, Platelet count, Potassium, Sodium, Thyroid Stimulating Hormone (TSH), Total Bilirubin, Total Neutrophils, Blood Urea Nitrogen (BUN) and White Blood Cell count (WBC). Number of participants with Laboratory outside of clinical concern Range were summarized here. Data of high and low from the clinical concern range has been provided here. Here 'High' denotes above normal range and 'Low' denotes below normal range for all the categories.
Up to Week 52
Number of Participants With Laboratory Data of Clinical Concern for Urine Protein
Urine Samples were collected from Day 1 to Week 28 and Week 52 for analyses. In this dipstick test, the level of protein in urine samples was recorded as negative (Neg), trace (tr), 1+, 2+, and 3+ (the plus sign increases with a higher level of proteins in the urine: 1+=slightly positive, 2+=positive, 3+=high positive). Neg indicated no proteinuria and 3+(high positive) indicated worst proteinuria.
Day 1 to Week 28 and Week 52
Plasma Concentrations of Pazopanib
All participants in the eye drop containing arms had a single blood sample drawn for assessment of pazopanib plasma concentration at the Week 4, Week 24 and Week 24. The sample was drawn without restriction for the time interval between blood draw and the last dose of IP eye drops.
Week 4, Week 24 and Week 52
Phoenix
Arizona
85014
United States
GSK Investigational Site
Phoenix
Arizona
85020
United States
GSK Investigational Site
Tucson
Arizona
85704
United States
GSK Investigational Site
Tucson
Arizona
85710
United States
GSK Investigational Site
Irvine
California
92697
United States
GSK Investigational Site
Loma Linda
California
92354
United States
GSK Investigational Site
Poway
California
92064
United States
GSK Investigational Site
Santa Ana
California
92705
United States
GSK Investigational Site
Golden
Colorado
80401
United States
GSK Investigational Site
Fort Myers
Florida
33901
United States
GSK Investigational Site
Winter Haven
Florida
33880
United States
GSK Investigational Site
Chicago
Illinois
60612
United States
GSK Investigational Site
Leawood
Kansas
66211
United States
GSK Investigational Site
Paducah
Kentucky
42001
United States
GSK Investigational Site
Baltimore
Maryland
21287
United States
GSK Investigational Site
Boston
Massachusetts
02114
United States
GSK Investigational Site
Royal Oak
Michigan
48073
United States
GSK Investigational Site
Traverse City
Michigan
49686
United States
GSK Investigational Site
New York
New York
10003
United States
GSK Investigational Site
Asheville
North Carolina
28803
United States
GSK Investigational Site
Chapel Hill
North Carolina
27599
United States
GSK Investigational Site
Charlotte
North Carolina
28210
United States
GSK Investigational Site
Beachwood
Ohio
44122
United States
GSK Investigational Site
Cleveland
Ohio
44130
United States
GSK Investigational Site
Cleveland
Ohio
44195
United States
GSK Investigational Site
Columbus
Ohio
43212
United States
GSK Investigational Site
Ashland
Oregon
97520
United States
GSK Investigational Site
Portland
Oregon
97239
United States
GSK Investigational Site
Philadelphia
Pennsylvania
19107
United States
GSK Investigational Site
Austin
Texas
78705
United States
GSK Investigational Site
Dallas
Texas
75231
United States
GSK Investigational Site
Fort Worth
Texas
76104
United States
GSK Investigational Site
Salt Lake City
Utah
84107
United States
GSK Investigational Site
Seattle
Washington
98104
United States
GSK Investigational Site
Silverdale
Washington
98383
United States
GSK Investigational Site
Madison
Wisconsin
53705
United States
GSK Investigational Site
Sydney
New South Wales
2000
Australia
GSK Investigational Site
Sydney
New South Wales
2150
Australia
GSK Investigational Site
Melbourne
Victoria
Australia
GSK Investigational Site
Nedlands
Western Australia
6009
Australia
GSK Investigational Site
Brussels
1020
Belgium
GSK Investigational Site
Liège
4000
Belgium
GSK Investigational Site
Vancouver
British Columbia
V5Z 3N9
Canada
GSK Investigational Site
Victoria
British Columbia
V8V 4X3
Canada
GSK Investigational Site
Halifax
Nova Scotia
B3H 2Y9
Canada
GSK Investigational Site
London
Ontario
N6A 4V2
Canada
GSK Investigational Site
Mississauga
Ontario
L4W 1W9
Canada
GSK Investigational Site
Toronto
Ontario
M4N 3M5
Canada
GSK Investigational Site
Aarhus
DK-8000
Denmark
GSK Investigational Site
Glostrup Municipality
Denmark
GSK Investigational Site
Freiburg im Breisgau
Baden-Wurttemberg
79106
Germany
GSK Investigational Site
Tübingen
Baden-Wurttemberg
72076
Germany
GSK Investigational Site
Munich
Bavaria
80336
Germany
GSK Investigational Site
Bonn
North Rhine-Westphalia
53127
Germany
GSK Investigational Site
Dresden
Saxony
01307
Germany
GSK Investigational Site
Leipzig
Saxony
04103
Germany
GSK Investigational Site
Kiel
Schleswig-Holstein
24105
Germany
GSK Investigational Site
Udine
Friuli Venezia Giulia
33100
Italy
GSK Investigational Site
Milan
Lombardy
20132
Italy
GSK Investigational Site
Milan
Lombardy
20157
Italy
GSK Investigational Site
Turin
Piedmont
10122
Italy
GSK Investigational Site
Padova
Veneto
35128
Italy
GSK Investigational Site
Aichi
460-0011
Japan
GSK Investigational Site
Aichi
462-0825
Japan
GSK Investigational Site
Aichi
466-8560
Japan
GSK Investigational Site
Chiba
279-0021
Japan
GSK Investigational Site
Fukuoka
812-8582
Japan
GSK Investigational Site
Fukushima
960-1295
Japan
GSK Investigational Site
Hokkaido
001-0016
Japan
GSK Investigational Site
Hokkaido
060-8604
Japan
GSK Investigational Site
Kagawa
761-0793
Japan
GSK Investigational Site
Tokyo
101-8309
Japan
GSK Investigational Site
Linköping
SE-581 85
Sweden
GSK Investigational Site
Örebro
SE-701 85
Sweden
GSK Investigational Site
Stockholm
SE-112 82
Sweden
GSK Investigational Site
Uppsala
SE-751 85
Sweden
FG001
Pazopanib Eye Drops 5 mg/mL TID
Only the study eye (one eye) per participant enrolled in the study received pazopanib eye drops 5 milligram/milliliter (mg/mL) TID. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week Treatment Period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
FG002
Pazopanib Eye Drops 5 mg/mL QID
Only the study eye (one eye) per participant enrolled in the study received pazopanib eye drops 5 mg/mL QID. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week Treatment Period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
FG003
Pazopanib Eye Drops 10 mg/mL BID
Only the study eye (one eye) per participant enrolled in the study received pazopanib eye drops 10 mg/mL twice daily. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week Treatment Period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
FG004
Pazopanib Eye Drops 10 mg/mL TID
Only the study eye (one eye) per participant enrolled in the study received pazopanib eye drops 10 mg/mL thrice daily. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week Treatment Period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
FG005
Pazopanib Eye Drops 10 mg/mL QID
Only the study eye (one eye) per participant enrolled in the study received pazopanib eye drops 10 mg/mL four times daily. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week Treatment Period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
FG006
Ranibizumab Injections Active Open-label Control Arm
Participants enrolled in this arm received no eye drops. They received a 0.20 mL to 0.23 mL fill of 10 mg/mL Ranibizumab injection once every four weeks throughout the entire 52 weeks of the study.
FG00073 subjects
FG00172 subjects
FG00274 subjects
FG00373 subjects
FG00473 subjects
FG00572 subjects
FG00673 subjects
COMPLETED
FG00065 subjects
FG00166 subjects
FG00271 subjects
FG00367 subjects
FG00467 subjects
FG00565 subjects
FG00662 subjects
NOT COMPLETED
FG0008 subjects
FG0016 subjects
FG0023 subjects
FG0036 subjects
FG0046 subjects
FG0057 subjects
FG00611 subjects
Type
Comment
Reasons
Adverse Event
FG0005 subjects
FG0012 subjects
FG0022 subjects
FG0032 subjects
FG0045 subjects
FG0057 subjects
FG0062 subjects
Lost to Follow-up
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0031 subjects
FG004
Withdrawal by Subject
FG0003 subjects
FG0013 subjects
FG0021 subjects
FG0032 subjects
FG004
Protocol Violation
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG004
Physician Decision
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Placebo Control Arm QID
Only the study eye (one eye) per participant enrolled in the study received Placebo QID. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week treatment period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
BG001
Pazopanib Eye Drops 5 mg/mL TID
Only the study eye (one eye) per participant enrolled in the study received pazopanib eye drops 5 mg/mL TID. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week Treatment Period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
BG002
Pazopanib Eye Drops 5 mg/mL QID
Only the study eye (one eye) per participant enrolled in the study received pazopanib eye drops 5 mg/mL QID. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week Treatment Period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
BG003
Pazopanib Eye Drops 10 mg/mL BID
Only the study eye (one eye) per participant enrolled in the study received pazopanib eye drops 10 mg/mL twice daily. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week Treatment Period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
BG004
Pazopanib Eye Drops 10 mg/mL TID
Only the study eye (one eye) per participant enrolled in the study received pazopanib eye drops 10 mg/mL thrice daily. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week Treatment Period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
BG005
Pazopanib Eye Drops 10 mg/mL QID
Only the study eye (one eye) per participant enrolled in the study received pazopanib eye drops 10 mg/mL four times daily. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week Treatment Period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
BG006
Ranibizumab Injections Active Open-label Control Arm
Participants enrolled in this arm received no eye drops. They received a 0.20 mL to 0.23 mL fill of 10 mg/mL Ranibizumab injection once every four weeks throughout the entire 52 weeks of the study.
BG007
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00073
BG00172
BG00274
BG00373
BG00473
BG00572
BG00673
BG007510
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
Years
Title
Denominators
Categories
Title
Measurements
BG00075.6± 9.42
BG00174.4± 7.60
BG00275.1± 8.19
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00039
BG00143
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Change From Baseline in Best-corrected Visual Acuity (BCVA) as Measured by the Number of Letters Read on the Early Treatment of Diabetic Retinopathy Study (ETDRS) Grading Charts at a Starting Distance of 4 Meters at Week 52
BCVA was measured in the study eye using the ETDRS grading charts starting at a test distance of 4 meters. The ETDRS grading chart was of at least 24 to 78 letters. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved. There were seven cut off points in change from baseline visual acuity on ETDRS grading chart which are, 15 to 29, 10 to 14, 5 to 9, -4 to 4, -5 to -9, -10 to -14 and -15 to -29 letters. The change from baseline was calculated by subtracting the baseline values from the individual post-randomization values. If either the baseline or post-randomization value was missing, the change from baseline was set to missing as well. Day 1 values are considered as Baseline in this study.
Intent to Treat Population - It consisted of all randomized participants, according to the treatment groups assigned by randomization (i.e., planned rather than the actual treatment regimen), who received at least one dose of study medication. Only participants with data available at the indicated time points were analyzed.
Posted
Least Squares Mean
Standard Error
Letters
Day 1 and 52 weeks
ID
Title
Description
OG000
Placebo Control Arm QID
Only the study eye (one eye) per participant enrolled in the study received Placebo QID. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week treatment period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
OG001
Pazopanib Eye Drops 5 mg/mL TID
Only the study eye (one eye) per participant enrolled in the study received pazopanib eye drops 5 mg/mL TID. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week Treatment Period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
OG002
Pazopanib Eye Drops 5 mg/mL QID
Only the study eye (one eye) per participant enrolled in the study received pazopanib eye drops 5 mg/mL QID. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week Treatment Period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
OG003
Units
Counts
Participants
OG00073
OG00172
OG00274
OG003
Title
Denominators
Categories
Title
Measurements
OG0000.22± 1.006
OG0011.15± 1.004
OG0021.81± 0.975
OG003
Secondary
Percentage of Ranibizumab Re-injections Received Over 28 and 52 Weeks
The investigator interpreted each Week 4 to Week 52 Optical coherence tomography (OCT) scan, BCVA score, and available Fluorescein angiography (FA)/Fundus photography (FP) and re-injected if one or more criteria were met. The criteria were: Evidence of Intraretinal (IR) (with or without cysts) fluid or Subretinal (SR) fluid, a serous retinal pigment epithelial detachment, a notable decline in Visual Acuity, new SR or IR macular hemorrhage that the investigator judges is associated with Choroidal neovascularization, increased lesion size on FA relative to the last angiogram as judged by the investigator or leakage on FA that the investigator judges would benefit from re-injection. Injection rate over 52 weeks was computed by taking the number of injections received divided by the number of visits for the participant. Likewise for 28 weeks it was estimated as the number of post baseline injections received divided by the number of post baseline visits at or before the week 28 visit.
Intent to Treat Population
Posted
Least Squares Mean
Standard Error
Percentage of re-injections
Up to 52 weeks
ID
Title
Description
OG000
Placebo Control Arm QID
Only the study eye (one eye) per participant enrolled in the study received Placebo QID. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week treatment period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
Secondary
Number of Participants With BCVA Over Time
BCVA was measured in the study eye using the ETDRS grading charts starting at a test distance of 4 meters. The ETDRS grading chart was of at least 24 to 78 letters. There were seven cut off points in change from baseline visual acuity on ETDRS grading chart which are, 15 to 29, 10 to 14, 5 to 9, -4 to 4, -5 to -9, -10 to -14 and -15 to -29 letters.
Intent to Treat Population. Only participants with data available at the indicated time points were analyzed.
Posted
Count of Participants
Participants
Up to Week 52
ID
Title
Description
OG000
Placebo Control Arm QID
Only the study eye (one eye) per participant enrolled in the study received Placebo QID. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week treatment period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
OG001
Pazopanib Eye Drops 5 mg/mL TID
Only the study eye (one eye) per participant enrolled in the study received pazopanib eye drops 5 mg/mL TID. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week Treatment Period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
Secondary
Number of Participants Analyzed for Visual Acuity (VA) Response Over Time
VA was measured in the study eye using the ETDRS grading charts starting at a test distance of 4 meters.The ETDRS grading chart was of at least 24 to 78 letters. There were seven cut off points in change from baseline visual acuity on ETDRS grading chart which are, 15 to 29, 10 to 14, 5 to 9, -4 to 4, -5 to -9, -10 to -14 and -15 to -29 letters. This outcome measure contains the number of participants who were analyzed for VA response.
Intent to Treat Population
Posted
Count of Participants
Participants
Week 52
ID
Title
Description
OG000
Placebo Control Arm QID
Only the study eye (one eye) per participant enrolled in the study received Placebo QID. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week treatment period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
OG001
Pazopanib Eye Drops 5 mg/mL TID
Only the study eye (one eye) per participant enrolled in the study received pazopanib eye drops 5 mg/mL TID. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week Treatment Period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
Secondary
Change From Baseline in Center Point Thickness (CPT) Over Time
CPT was the inner limiting membrane to the beginning of the retinal pigment epithelium (RPE) inclusive of SR fluid. The outer boundary included the outer segment of the photoreceptors and not included the RPE. The change from baseline was calculated by subtracting the baseline values from the individual post-randomization values. If either the baseline or post-randomization value was missing, the change from baseline was set to missing as well. Day 1 values are considered as Baseline in this study. In amendment 3, inclusion criterion number 5 was revised to remove the required quantitative OCT component. OCT examination was used to supplement FA findings and provided qualitative (presence of SR and/or IR fluid) and quantitative (a CPT that is at least 250 microns) evidence of an active subfoveal lesion. Hence data for pre and post amendment have been provided separately.
Intent to Treat Population
Posted
Mean
Standard Deviation
Microns
Baseline and Week 52
ID
Title
Description
OG000
Placebo Control Arm QID
Only the study eye (one eye) per participant enrolled in the study received Placebo QID. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week treatment period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
Secondary
Number of Participants That Met Criteria for Re-injection
The investigator interpreted each Week 4 to Week 52 Optical coherence tomography (OCT) scan, BCVA score, and available Fluorescein angiography (FA)/Fundus photography (FP) and re-injected if one or more criteria were met. The criteria were: Evidence of Intraretinal (IR) (with or without cysts) fluid or Subretinal (SR) fluid, a serous retinal pigment epithelial detachment, a notable decline in Visual Acuity, new SR or IR macular hemorrhage that the investigator judges is associated with Choroidal neovascularization, increased lesion size on FA relative to the last angiogram as judged by the investigator or leakage on FA that the investigator judges would benefit from re-injection.
Intent to Treat Population
Posted
Count of Participants
Participants
Up to Week 52
ID
Title
Description
OG000
Placebo Control Arm QID
Only the study eye (one eye) per participant enrolled in the study received Placebo QID. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week treatment period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
OG001
Pazopanib Eye Drops 5 mg/mL TID
Secondary
Change From Baseline in the Area of Choroidal Neovascularisation (CNV)
Choroidal neovascularisation is progressive worsening of vision that can cause hemorrhage and exudation, and finally disciform scarring and retinal atrophy. The change from baseline was calculated by subtracting the baseline values from the individual post-randomization values. If either the baseline or post-randomization value was missing, the change from baseline was set to missing as well. Day 1 values are considered as Baseline in this study.
Intent to Treat Population
Posted
Least Squares Mean
Standard Error
Millimeter (mm)^2
Day 1, Week 28 and Week 52
ID
Title
Description
OG000
Placebo Control Arm QID
Only the study eye (one eye) per participant enrolled in the study received Placebo QID. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week treatment period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
OG001
Pazopanib Eye Drops 5 mg/mL TID
Only the study eye (one eye) per participant enrolled in the study received pazopanib eye drops 5 mg/mL TID. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week Treatment Period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
Secondary
Change From Baseline in the Area of the CNV Lesion Complex (i.e. CNV, Blood, PED, and Fibrosis)
CNV is progressive worsening of vision that can cause hemorrhage and exudation, and finally disciform scarring and retinal atrophy. The change from baseline was calculated by subtracting the baseline values from the individual post-randomization values. If either the baseline or post-randomization value was missing, the change from baseline was set to missing as well. Day 1 values are considered as Baseline in this study.
Intent to Treat Population
Posted
Least Squares Mean
Standard Error
mm^2
Day 1, Week 28 and Week 52
ID
Title
Description
OG000
Placebo Control Arm QID
Only the study eye (one eye) per participant enrolled in the study received Placebo QID. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week treatment period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
OG001
Pazopanib Eye Drops 5 mg/mL TID
Only the study eye (one eye) per participant enrolled in the study received pazopanib eye drops 5 mg/mL TID. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week Treatment Period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
Secondary
Change From Baseline in the Area of Fluorescein Leakage
Fluorescein angiograms was performed at the Screening, Week 12, Week 28, and Week 52 Visits. All images, including any that were performed at the investigator's medical discretion, were transferred to the FPRC. Fluorescein was injected intravenously according to usual clinic procedures. Dose response was also examined under different aspects of re-injection, such as time to first injection, the percentage of participants that required an injection by Week 28, as well as the estimation of the probability of reinjection. FA assessments of area of fluorescein leakage, CNV area and area of CNV lesion complex were also examined for dose differentiation.
Intent to Treat Population
Posted
Least Squares Mean
Standard Error
mm^2
Day 1, Week 28 and Week 52
ID
Title
Description
OG000
Placebo Control Arm QID
Only the study eye (one eye) per participant enrolled in the study received Placebo QID. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week treatment period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
OG001
Pazopanib Eye Drops 5 mg/mL TID
Secondary
Change in Area of Serous Sensory Retinal Detachment (SSRD)
This is an Optical coherence tomography (OCT) parameter used to manually measure thickness along any scan. OCT was performed at week 28 and week 52.
Intent to Treat Population
Posted
Least Squares Mean
Standard Error
mm^2
Day 1, Week 28 and Week 52
ID
Title
Description
OG000
Placebo Control Arm QID
Only the study eye (one eye) per participant enrolled in the study received Placebo QID. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week treatment period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
OG001
Pazopanib Eye Drops 5 mg/mL TID
Only the study eye (one eye) per participant enrolled in the study received pazopanib eye drops 5 mg/mL TID. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week Treatment Period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
Secondary
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is any untoward medical occurrence that, at any dose results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect.
Safety Population
Posted
Count of Participants
Participants
Up to 52 Weeks
ID
Title
Description
OG000
Placebo Control Arm QID
Only the study eye (one eye) per participant enrolled in the study received Placebo QID. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week treatment period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
OG001
Pazopanib Eye Drops 5 mg/mL TID
Only the study eye (one eye) per participant enrolled in the study received pazopanib eye drops 5 mg/mL TID. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week Treatment Period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
Secondary
Summary of Potentially Clinically Important Findings for Ophthalmic Examinations
Opthalmicexaminations were done on Ocular alignment and motility, pupillary function, and visual fields by confrontation. Slit-lamp biomicroscopic examination of the anterior segment structure was performed. Fundus slit-lamp biomicroscopic examination, including use of accessory diagnostic lenses, to view the vitreous, retina (including posterior pole and periphery), macula, vasculature, and optic nerve was also performed. These examinations were performed on the study eye (SE) and the Fellow eye (FE). Participants with abnormal findings are listed here.
Safety population
Posted
Count of Participants
Participants
Up to Week 52
ID
Title
Description
OG000
Placebo Control Arm QID
Only the study eye (one eye) per participant enrolled in the study received Placebo QID. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week treatment period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
OG001
Pazopanib Eye Drops 5 mg/mL TID
Secondary
Summary of Intraocular Pressure Exam Findings
Intraocular pressure (IOP) measurement was done with Goldmann tonometer. Intraocular pressure was measured prior to dilating the pupil and, to account for diurnal variation, at approximately the same time of day for every visit.
Safety Population
Posted
Count of Participants
Participants
Up to week 52
ID
Title
Description
OG000
Placebo Control Arm QID
Only the study eye (one eye) per participant enrolled in the study received Placebo QID. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week treatment period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
OG001
Pazopanib Eye Drops 5 mg/mL TID
Only the study eye (one eye) per participant enrolled in the study received pazopanib eye drops 5 mg/mL TID. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week Treatment Period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
Secondary
Number of Participants With Vital Sign Values Outside of Clinical Concern Range
Vital signs including systolic and diastolic blood pressure and heart rate were measured throughout the study. Number of participants with vital signs outside of clinical concern Range were summarized. 'High' denotes above normal range and 'Low' denotes below normal range for all the categories. The potential clinical importance ranges (low and high) of the vital sign parameters were for systolic blood pressure (<85 and >160 millimeter of mercury [mmHg]), diastolic blood pressure (<45 and >100 mmHg) and heart rate (<40 and >110 beats per minute). Only those parameters for which at least one value of potential clinical importance was reported are summarized. The number of participants with potential clinical important vital parameter findings at any visit were reported.
Safety Population. Only participants with data available at the indicated time points were analyzed.
Posted
Count of Participants
Participants
Up to Week 52
ID
Title
Description
OG000
Placebo Control Arm QID
Only the study eye (one eye) per participant enrolled in the study received Placebo QID. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week treatment period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
Secondary
Summary of Abnormal Electrocardiogram (ECG) Findings
12-Lead ECGs were performed in triplicate and were obtained on Weeks 4 to Week 28 and Week 52. The on-treatment ECGs were used to ascertain any risk of QTc interval prolongation at extremely low pazopanib exposures compared to what was routinely observed in participants with cancer. The on-treatment ECG data collected from participants assigned to one of the control arms also provided ECG background rate data for participants not exposed to pazopanib. Participants with Clinically significant abnormal ECGs are included here.
Safety population. Only participants with data available at the indicated time points were analyzed.
Posted
Count of Participants
Participants
Week 4, Week 28, Week 44 and Week 52
ID
Title
Description
OG000
Placebo Control Arm QID
Only the study eye (one eye) per participant enrolled in the study received Placebo QID. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week treatment period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
OG001
Pazopanib Eye Drops 5 mg/mL TID
Secondary
Summary of Hematology and Clinical Chemistry Parameters Data of Clinical Concern
The Laboratory Parameters included Alanine Amino Transferase (ALT), Albumin, Alkaline Phosphatase, Aspartate Amino Transferase (AST), Calcium, Bicarbonate, Creatinine, Glucose, Hemoglobin, Lymphocytes, Platelet count, Potassium, Sodium, Thyroid Stimulating Hormone (TSH), Total Bilirubin, Total Neutrophils, Blood Urea Nitrogen (BUN) and White Blood Cell count (WBC). Number of participants with Laboratory outside of clinical concern Range were summarized here. Data of high and low from the clinical concern range has been provided here. Here 'High' denotes above normal range and 'Low' denotes below normal range for all the categories.
Safety Population. Only participants with data available at the indicated time points were analyzed.
Posted
Count of Participants
Participants
Up to Week 52
ID
Title
Description
OG000
Placebo Control Arm QID
Only the study eye (one eye) per participant enrolled in the study received Placebo QID. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week treatment period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
OG001
Secondary
Number of Participants With Laboratory Data of Clinical Concern for Urine Protein
Urine Samples were collected from Day 1 to Week 28 and Week 52 for analyses. In this dipstick test, the level of protein in urine samples was recorded as negative (Neg), trace (tr), 1+, 2+, and 3+ (the plus sign increases with a higher level of proteins in the urine: 1+=slightly positive, 2+=positive, 3+=high positive). Neg indicated no proteinuria and 3+(high positive) indicated worst proteinuria.
Safety Population
Posted
Count of Participants
Participants
Day 1 to Week 28 and Week 52
ID
Title
Description
OG000
Placebo Control Arm QID
Only the study eye (one eye) per participant enrolled in the study received Placebo QID. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week treatment period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
OG001
Pazopanib Eye Drops 5 mg/mL TID
Only the study eye (one eye) per participant enrolled in the study received pazopanib eye drops 5 mg/mL TID. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week Treatment Period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
Secondary
Plasma Concentrations of Pazopanib
All participants in the eye drop containing arms had a single blood sample drawn for assessment of pazopanib plasma concentration at the Week 4, Week 24 and Week 24. The sample was drawn without restriction for the time interval between blood draw and the last dose of IP eye drops.
Safety Population. Only participants with data available at the indicated time points were analyzed.
Posted
Mean
95% Confidence Interval
nanogram/milliliter
Week 4, Week 24 and Week 52
ID
Title
Description
OG000
Pazopanib Eye Drops 5 mg/mL TID
Only the study eye (one eye) per participant enrolled in the study received pazopanib eye drops 5 mg/mL TID. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week Treatment Period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
OG001
Pazopanib Eye Drops 5 mg/mL QID
Only the study eye (one eye) per participant enrolled in the study received pazopanib eye drops 5 mg/mL QID. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week Treatment Period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
Time Frame
All AEs and SAEs were collected during the treatment period (up to 52 weeks)
Description
All AEs and SAEs were reported on Safety Population.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Placebo Control Arm QID
Only the study eye (one eye) per participant enrolled in the study received Placebo QID. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week treatment period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
2
73
11
73
52
73
EG001
Pazopanib Eye Drops 5 mg/mL TID
Only the study eye (one eye) per participant enrolled in the study received pazopanib eye drops 5 mg/mL TID. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week Treatment Period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
1
72
10
72
34
72
EG002
Pazopanib Eye Drops 5 mg/mL QID
Only the study eye (one eye) per participant enrolled in the study received pazopanib eye drops 5 mg/mL QID. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week Treatment Period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
1
74
12
74
47
74
EG003
Pazopanib Eye Drops 10 mg/mL BID
Only the study eye (one eye) per participant enrolled in the study received pazopanib eye drops 10 mg/mL twice daily. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week Treatment Period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
0
73
11
73
44
73
EG004
Pazopanib Eye Drops 10 mg/mL TID
Only the study eye (one eye) per participant enrolled in the study received pazopanib eye drops 10 mg/mL thrice daily. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week Treatment Period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
3
73
10
73
46
73
EG005
Pazopanib Eye Drops 10 mg/mL QID
Only the study eye (one eye) per participant enrolled in the study received pazopanib eye drops 10 mg/mL four times daily. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week Treatment Period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
0
72
11
72
41
72
EG006
Ranibizumab Injections Active Open-label Control Arm
Participants enrolled in this arm received no eye drops. They received a 0.20 mL to 0.23 mL fill of 10 mg/mL Ranibizumab injection once every four weeks throughout the entire 52 weeks of the study.
1
73
6
73
42
73
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Cerebrovascular accident
Nervous system disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected73 at risk
EG0011 affected72 at risk
EG0021 affected74 at risk
EG0030 affected73 at risk
EG0041 affected73 at risk
EG0050 affected72 at risk
EG0060 affected73 at risk
Syncope
Nervous system disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected73 at risk
EG0011 affected72 at risk
EG0020 affected74 at risk
EG003
Transient ischaemic attack
Nervous system disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected73 at risk
EG0010 affected72 at risk
EG0021 affected74 at risk
EG003
Ataxia
Nervous system disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected73 at risk
EG0010 affected72 at risk
EG0020 affected74 at risk
EG003
Brain Stem Stroke
Nervous system disorders
Brain stem stroke
Systematic Assessment
EG0000 affected73 at risk
EG0010 affected72 at risk
EG0020 affected74 at risk
EG003
Cerebral haemorrhage
Nervous system disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected73 at risk
EG0011 affected72 at risk
EG0020 affected74 at risk
EG003
Cervical myelopathy
Nervous system disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected73 at risk
EG0010 affected72 at risk
EG0020 affected74 at risk
EG003
Encephalopathy
Nervous system disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected73 at risk
EG0010 affected72 at risk
EG0020 affected74 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected73 at risk
EG0010 affected72 at risk
EG0021 affected74 at risk
EG003
Small intestinal obstruction
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected73 at risk
EG0010 affected72 at risk
EG0020 affected74 at risk
EG003
Abdominal hernia
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected73 at risk
EG0010 affected72 at risk
EG0020 affected74 at risk
EG003
Colitis
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected73 at risk
EG0010 affected72 at risk
EG0020 affected74 at risk
EG003
Crohn's disease
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected73 at risk
EG0011 affected72 at risk
EG0020 affected74 at risk
EG003
Duodenal ulcer
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected73 at risk
EG0010 affected72 at risk
EG0020 affected74 at risk
EG003
Gastric ulcer haemorrhage
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected73 at risk
EG0010 affected72 at risk
EG0020 affected74 at risk
EG003
Gastritis
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected73 at risk
EG0010 affected72 at risk
EG0020 affected74 at risk
EG003
Intestinal perforation
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected73 at risk
EG0011 affected72 at risk
EG0020 affected74 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0000 affected73 at risk
EG0010 affected72 at risk
EG0020 affected74 at risk
EG003
Endophthalmitis
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0000 affected73 at risk
EG0010 affected72 at risk
EG0020 affected74 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0002 affected73 at risk
EG0010 affected72 at risk
EG0020 affected74 at risk
EG003
Abscess intestinal
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0000 affected73 at risk
EG0010 affected72 at risk
EG0020 affected74 at risk
EG003
Erysipelas
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0000 affected73 at risk
EG0010 affected72 at risk
EG0020 affected74 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0000 affected73 at risk
EG0010 affected72 at risk
EG0020 affected74 at risk
EG003
Infection
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0001 affected73 at risk
EG0010 affected72 at risk
EG0020 affected74 at risk
EG003
Periorbital cellulitis
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0000 affected73 at risk
EG0010 affected72 at risk
EG0021 affected74 at risk
EG003
Bladder cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.0
Systematic Assessment
EG0001 affected73 at risk
EG0010 affected72 at risk
EG0020 affected74 at risk
EG003
Colon cancer metastatic
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.0
Systematic Assessment
EG0000 affected73 at risk
EG0010 affected72 at risk
EG0020 affected74 at risk
EG003
Colon neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.0
Systematic Assessment
EG0000 affected73 at risk
EG0010 affected72 at risk
EG0020 affected74 at risk
EG003
Gastrointestinal cancer metastatic
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.0
Systematic Assessment
EG0000 affected73 at risk
EG0010 affected72 at risk
EG0021 affected74 at risk
EG003
Lung cancer metastatic
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.0
Systematic Assessment
EG0001 affected73 at risk
EG0010 affected72 at risk
EG0020 affected74 at risk
EG003
Lung neoplasm malignant
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.0
Systematic Assessment
EG0001 affected73 at risk
EG0010 affected72 at risk
EG0020 affected74 at risk
EG003
Neoplasm malignant
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.0
Systematic Assessment
EG0000 affected73 at risk
EG0010 affected72 at risk
EG0020 affected74 at risk
EG003
Ovarian cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.0
Systematic Assessment
EG0000 affected73 at risk
EG0010 affected72 at risk
EG0020 affected74 at risk
EG003
Prostate cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.0
Systematic Assessment
EG0000 affected73 at risk
EG0010 affected72 at risk
EG0021 affected74 at risk
EG003
Cartilage injury
Injury, poisoning and procedural complications
MedDRA 18.0
Systematic Assessment
EG0000 affected73 at risk
EG0010 affected72 at risk
EG0020 affected74 at risk
EG003
Hip fracture
Injury, poisoning and procedural complications
MedDRA 18.0
Systematic Assessment
EG0000 affected73 at risk
EG0010 affected72 at risk
EG0020 affected74 at risk
EG003
Humerus fracture
Injury, poisoning and procedural complications
MedDRA 18.0
Systematic Assessment
EG0000 affected73 at risk
EG0011 affected72 at risk
EG0020 affected74 at risk
EG003
Pelvic fracture
Injury, poisoning and procedural complications
MedDRA 18.0
Systematic Assessment
EG0001 affected73 at risk
EG0010 affected72 at risk
EG0020 affected74 at risk
EG003
Post procedural complication
Injury, poisoning and procedural complications
MedDRA 18.0
Systematic Assessment
EG0000 affected73 at risk
EG0011 affected72 at risk
EG0020 affected74 at risk
EG003
Post-traumatic neck syndrome
Injury, poisoning and procedural complications
MedDRA 18.0
Systematic Assessment
EG0000 affected73 at risk
EG0010 affected72 at risk
EG0020 affected74 at risk
EG003
Rib fracture
Injury, poisoning and procedural complications
MedDRA 18.0
Systematic Assessment
EG0000 affected73 at risk
EG0010 affected72 at risk
EG0020 affected74 at risk
EG003
Road traffic accident
Injury, poisoning and procedural complications
MedDRA 18.0
Systematic Assessment
EG0000 affected73 at risk
EG0010 affected72 at risk
EG0020 affected74 at risk
EG003
Spinal cord injury
Injury, poisoning and procedural complications
MedDRA 18.0
Systematic Assessment
EG0000 affected73 at risk
EG0010 affected72 at risk
EG0020 affected74 at risk
EG003
Angina pectoris
Cardiac disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected73 at risk
EG0010 affected72 at risk
EG0022 affected74 at risk
EG003
Atrioventricular block second degree
Cardiac disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected73 at risk
EG0010 affected72 at risk
EG0020 affected74 at risk
EG003
Cardiac failure congestive
Cardiac disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected73 at risk
EG0010 affected72 at risk
EG0020 affected74 at risk
EG003
Coronary artery disease
Cardiac disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected73 at risk
EG0010 affected72 at risk
EG0021 affected74 at risk
EG003
Mitral valve disease
Cardiac disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected73 at risk
EG0010 affected72 at risk
EG0020 affected74 at risk
EG003
Myocardial infarction
Cardiac disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected73 at risk
EG0010 affected72 at risk
EG0021 affected74 at risk
EG003
Chronic obstructive pulmonary disease
Respiratory, thoracic and mediastinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected73 at risk
EG0010 affected72 at risk
EG0021 affected74 at risk
EG003
Pneumonia aspiration
Respiratory, thoracic and mediastinal disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected73 at risk
EG0010 affected72 at risk
EG0020 affected74 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected73 at risk
EG0010 affected72 at risk
EG0020 affected74 at risk
EG003
Fluid overload
Metabolism and nutrition disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected73 at risk
EG0010 affected72 at risk
EG0020 affected74 at risk
EG003
Hypercalcaemia
Metabolism and nutrition disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected73 at risk
EG0010 affected72 at risk
EG0020 affected74 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected73 at risk
EG0010 affected72 at risk
EG0020 affected74 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected73 at risk
EG0010 affected72 at risk
EG0020 affected74 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected73 at risk
EG0011 affected72 at risk
EG0020 affected74 at risk
EG003
Lumbar spinal stenosis
Musculoskeletal and connective tissue disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected73 at risk
EG0010 affected72 at risk
EG0021 affected74 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected73 at risk
EG0010 affected72 at risk
EG0020 affected74 at risk
EG003
Osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected73 at risk
EG0010 affected72 at risk
EG0020 affected74 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected73 at risk
EG0011 affected72 at risk
EG0020 affected74 at risk
EG003
Hypertensive nephropathy
Renal and urinary disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected73 at risk
EG0010 affected72 at risk
EG0020 affected74 at risk
EG003
Renal artery stenosis
Renal and urinary disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected73 at risk
EG0010 affected72 at risk
EG0020 affected74 at risk
EG003
Renal cyst haemorrhage
Renal and urinary disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected73 at risk
EG0011 affected72 at risk
EG0020 affected74 at risk
EG003
Renal failure acute
Renal and urinary disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected73 at risk
EG0010 affected72 at risk
EG0021 affected74 at risk
EG003
Bile duct obstruction
Hepatobiliary disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected73 at risk
EG0010 affected72 at risk
EG0020 affected74 at risk
EG003
Bile duct stone
Hepatobiliary disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected73 at risk
EG0010 affected72 at risk
EG0020 affected74 at risk
EG003
Cholecystitis acute
Hepatobiliary disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected73 at risk
EG0010 affected72 at risk
EG0020 affected74 at risk
EG003
Cholelithiasis
Hepatobiliary disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected73 at risk
EG0010 affected72 at risk
EG0020 affected74 at risk
EG003
Aortic aneurysm
Vascular disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected73 at risk
EG0011 affected72 at risk
EG0020 affected74 at risk
EG003
Hypertension
Vascular disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected73 at risk
EG0010 affected72 at risk
EG0020 affected74 at risk
EG003
Shock
Vascular disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected73 at risk
EG0010 affected72 at risk
EG0020 affected74 at risk
EG003
Vertigo
Ear and labyrinth disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected73 at risk
EG0010 affected72 at risk
EG0020 affected74 at risk
EG003
Benign prostatic hyperplasia
Reproductive system and breast disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected73 at risk
EG0010 affected72 at risk
EG0020 affected74 at risk
EG003
Prostatomegaly
Reproductive system and breast disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected73 at risk
EG0010 affected72 at risk
EG0021 affected74 at risk
EG003
Haemorrhagic arteriovenous malformation
Congenital, familial and genetic disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected73 at risk
EG0010 affected72 at risk
EG0020 affected74 at risk
EG003
Retinal haemorrhage
Eye disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected73 at risk
EG0011 affected72 at risk
EG0020 affected74 at risk
EG003
Device failure
General disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected73 at risk
EG0010 affected72 at risk
EG0020 affected74 at risk
EG003
Prothrombin time prolonged
Investigations
MedDRA 18.0
Systematic Assessment
EG0001 affected73 at risk
EG0010 affected72 at risk
EG0020 affected74 at risk
EG003
Iron deficiency anaemia
Blood and lymphatic system disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected73 at risk
EG0010 affected72 at risk
EG0020 affected74 at risk
EG003
Myasthenia gravis
Nervous system disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected73 at risk
EG0010 affected72 at risk
EG0020 affected74 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Nasopharyngitis
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG00011 affected73 at risk
EG0015 affected72 at risk
EG0026 affected74 at risk
EG00317 affected73 at risk
EG0045 affected73 at risk
EG00513 affected72 at risk
EG0065 affected73 at risk
Hypertension
Vascular disorders
MedDRA 18.0
Systematic Assessment
EG0003 affected73 at risk
EG0014 affected72 at risk
EG0025 affected74 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0009 affected73 at risk
EG0013 affected72 at risk
EG0021 affected74 at risk
EG003
Conjunctival haemorrhage
Eye disorders
MedDRA 18.0
Systematic Assessment
EG0005 affected73 at risk
EG0012 affected72 at risk
EG0021 affected74 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 18.0
Systematic Assessment
EG0008 affected73 at risk
EG0013 affected72 at risk
EG0026 affected74 at risk
EG003
Headache
Nervous system disorders
MedDRA 18.0
Systematic Assessment
EG0003 affected73 at risk
EG0012 affected72 at risk
EG0021 affected74 at risk
EG003
Retinal haemorrhage
Eye disorders
MedDRA 18.0
Systematic Assessment
EG0005 affected73 at risk
EG0013 affected72 at risk
EG0023 affected74 at risk
EG003
Visual acuity reduced
Eye disorders
MedDRA 18.0
Systematic Assessment
EG0003 affected73 at risk
EG0013 affected72 at risk
EG0022 affected74 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 18.0
Systematic Assessment
EG0005 affected73 at risk
EG0012 affected72 at risk
EG0025 affected74 at risk
EG003
Eye pain
Eye disorders
MedDRA 18.0
Systematic Assessment
EG0007 affected73 at risk
EG0011 affected72 at risk
EG0021 affected74 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0002 affected73 at risk
EG0011 affected72 at risk
EG0026 affected74 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0004 affected73 at risk
EG0013 affected72 at risk
EG0022 affected74 at risk
EG003
Sinusitis
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0001 affected73 at risk
EG0011 affected72 at risk
EG0024 affected74 at risk
EG003
Vitreous floaters
Eye disorders
MedDRA 18.0
Systematic Assessment
EG0003 affected73 at risk
EG0012 affected72 at risk
EG0022 affected74 at risk
EG003
Bronchitis
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0003 affected73 at risk
EG0011 affected72 at risk
EG0022 affected74 at risk
EG003
Vision blurred
Eye disorders
MedDRA 18.0
Systematic Assessment
EG0004 affected73 at risk
EG0011 affected72 at risk
EG0022 affected74 at risk
EG003
Influenza
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0000 affected73 at risk
EG0015 affected72 at risk
EG0022 affected74 at risk
EG003
Pain
General disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected73 at risk
EG0014 affected72 at risk
EG0022 affected74 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 18.0
Systematic Assessment
EG0002 affected73 at risk
EG0013 affected72 at risk
EG0024 affected74 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected73 at risk
EG0011 affected72 at risk
EG0020 affected74 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 18.0
Systematic Assessment
EG0002 affected73 at risk
EG0012 affected72 at risk
EG0021 affected74 at risk
EG003
Blepharitis
Eye disorders
MedDRA 18.0
Systematic Assessment
EG0002 affected73 at risk
EG0010 affected72 at risk
EG0023 affected74 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA 18.0
Systematic Assessment
EG0002 affected73 at risk
EG0014 affected72 at risk
EG0022 affected74 at risk
EG003
Punctate keratitis
Eye disorders
MedDRA 18.0
Systematic Assessment
EG0004 affected73 at risk
EG0011 affected72 at risk
EG0020 affected74 at risk
EG003
Seasonal allergy
Immune system disorders
MedDRA 18.0
Systematic Assessment
EG0003 affected73 at risk
EG0011 affected72 at risk
EG0024 affected74 at risk
EG003
Lacrimation increased
Eye disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected73 at risk
EG0011 affected72 at risk
EG0021 affected74 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected73 at risk
EG0011 affected72 at risk
EG0021 affected74 at risk
EG003
Anaemia
Blood and lymphatic system disorders
MedDRA 18.0
Systematic Assessment
EG0003 affected73 at risk
EG0010 affected72 at risk
EG0020 affected74 at risk
EG003
Conjunctivitis
Eye disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected73 at risk
EG0010 affected72 at risk
EG0022 affected74 at risk
EG003
Dry eye
Eye disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected73 at risk
EG0011 affected72 at risk
EG0021 affected74 at risk
EG003
Injection site haemorrhage
General disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected73 at risk
EG0010 affected72 at risk
EG0021 affected74 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0002 affected73 at risk
EG0010 affected72 at risk
EG0024 affected74 at risk
EG003
Conjunctival hyperaemia
Eye disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected73 at risk
EG0011 affected72 at risk
EG0024 affected74 at risk
EG003
Cataract cortical
Eye disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected73 at risk
EG0010 affected72 at risk
EG0024 affected74 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected73 at risk
EG0010 affected72 at risk
EG0020 affected74 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Point of Contact
Title
Organization
Phone
Extension
Email
GSK Response Center
GlaxoSmithKline
866-435-7343
ID
Term
D008268
Macular Degeneration
Ancestor Terms
ID
Term
D012162
Retinal Degeneration
D012164
Retinal Diseases
D005128
Eye Diseases
Browse Leaves
Not provided
Browse Branches
Not provided
ID
Term
D000069579
Ranibizumab
Ancestor Terms
ID
Term
D061067
Antibodies, Monoclonal, Humanized
D000911
Antibodies, Monoclonal
D000906
Antibodies
D007136
Immunoglobulins
D007162
Immunoproteins
D001798
Blood Proteins
D011506
Proteins
D000602
Amino Acids, Peptides, and Proteins
D012712
Serum Globulins
D005916
Globulins
Browse Leaves
Not provided
Browse Branches
Not provided
0 subjects
FG0050 subjects
FG0060 subjects
0 subjects
FG0050 subjects
FG0068 subjects
1 subjects
FG0050 subjects
FG0060 subjects
0 subjects
FG0050 subjects
FG0061 subjects
75.4
± 8.42
BG00475.6± 8.71
BG00576.2± 8.00
BG00674.9± 7.27
BG00775.3± 8.23
42
BG00345
BG00440
BG00546
BG00641
BG007296
Male
BG00034
BG00129
BG00232
BG00328
BG00433
BG00526
BG00632
BG007214
0
BG0030
BG0040
BG0050
BG0060
BG0070
Asian
BG0005
BG0014
BG0025
BG0036
BG0045
BG0054
BG0066
BG00735
Native Hawaiian or Other Pacific Islander
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
Black or African American
BG0000
BG0011
BG0020
BG0030
BG0040
BG0050
BG0060
BG0071
White
BG00068
BG00167
BG00269
BG00367
BG00468
BG00568
BG00667
BG007474
More than one race
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
Unknown or Not Reported
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
Pazopanib Eye Drops 10 mg/mL BID
Only the study eye (one eye) per participant enrolled in the study received pazopanib eye drops 10 mg/mL twice daily. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week Treatment Period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
OG004
Pazopanib Eye Drops 10 mg/mL TID
Only the study eye (one eye) per participant enrolled in the study received pazopanib eye drops 10 mg/mL thrice daily. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week Treatment Period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
OG005
Pazopanib Eye Drops 10 mg/mL QID
Only the study eye (one eye) per participant enrolled in the study received pazopanib eye drops 10 mg/mL four times daily. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week Treatment Period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
OG006
Ranibizumab Injections Active Open-label Control Arm
Participants enrolled in this arm received no eye drops. They received a 0.20 mL to 0.23 mL fill of 10 mg/mL Ranibizumab injection once every four weeks throughout the entire 52 weeks of the study.
73
OG00473
OG00572
OG00673
0.76
± 0.995
OG0040.28± 0.992
OG0050.62± 1.007
OG0061.42± 1.020
OG001
Pazopanib Eye Drops 5 mg/mL TID
Only the study eye (one eye) per participant enrolled in the study received pazopanib eye drops 5 mg/mL TID. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week Treatment Period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
OG002
Pazopanib Eye Drops 5 mg/mL QID
Only the study eye (one eye) per participant enrolled in the study received pazopanib eye drops 5 mg/mL QID. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week Treatment Period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
OG003
Pazopanib Eye Drops 10 mg/mL BID
Only the study eye (one eye) per participant enrolled in the study received pazopanib eye drops 10 mg/mL twice daily. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week Treatment Period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
OG004
Pazopanib Eye Drops 10 mg/mL TID
Only the study eye (one eye) per participant enrolled in the study received pazopanib eye drops 10 mg/mL thrice daily. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week Treatment Period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
OG005
Pazopanib Eye Drops 10 mg/mL QID
Only the study eye (one eye) per participant enrolled in the study received pazopanib eye drops 10 mg/mL four times daily. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week Treatment Period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
Units
Counts
Participants
OG00073
OG00172
OG00274
OG00373
OG00473
OG00572
Title
Denominators
Categories
Injection Rate at 28 Weeks
Title
Measurements
OG00065.04± 3.418
OG00155.03± 3.441
OG00267.92± 3.395
OG00366.11± 3.418
OG00461.61± 3.418
OG00559.42± 3.441
Overall Injection Rate at 52 weeks
Title
Measurements
OG00064.24± 3.263
OG00155.09± 3.286
OG00265.87± 3.241
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Statistics for Injection Rate at 28 Weeks is presented
ANOVA
0.1974
Adjusted p-Value has been presented.
Superiority or Other
OG000
OG002
Statistics for Injection Rate at 28 Weeks is presented
ANOVA
0.8263
Adjusted p-Value has been presented.
Superiority or Other
OG000
OG003
Statistics for Injection Rate at 28 Weeks is presented
ANOVA
0.8263
Adjusted p-Value has been presented.
Superiority or Other
OG000
OG004
Statistics for Injection Rate at 28 Weeks is presented
ANOVA
0.8263
Adjusted p-Value has been presented.
Superiority or Other
OG000
OG005
Statistics for Injection Rate at 28 Weeks is presented
ANOVA
0.7418
Adjusted p-Value has been presented.
Superiority or Other
OG000
OG001
Statistics for Overall Injection Rate at 52 weeks is presented
ANOVA
0.2429
Adjusted p-Value has been presented.
Superiority or Other
OG000
OG002
Statistics for Overall Injection Rate at 52 weeks is presented
ANOVA
0.9700
Adjusted p-Value has been presented.
Superiority or Other
OG000
OG003
Statistics for Overall Injection Rate at 52 weeks is presented
ANOVA
0.9700
Adjusted p-Value has been presented.
Superiority or Other
OG000
OG004
Statistics for Overall Injection Rate at 52 weeks is presented
ANOVA
0.9700
Adjusted p-Value has been presented.
Superiority or Other
OG000
OG005
Statistics for Overall Injection Rate at 52 weeks is presented
ANOVA
0.7673
Adjusted p-Value has been presented.
Superiority or Other
OG002
Pazopanib Eye Drops 5 mg/mL QID
Only the study eye (one eye) per participant enrolled in the study received pazopanib eye drops 5 mg/mL QID. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week Treatment Period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
OG003
Pazopanib Eye Drops 10 mg/mL BID
Only the study eye (one eye) per participant enrolled in the study received 10 mg/mL twice daily. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week Treatment Period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
OG004
Pazopanib Eye Drops 10 mg/mL TID
Only the study eye (one eye) per participant enrolled in the study received pazopanib eye drops 10 mg/mL thrice daily. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week Treatment Period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
OG005
Pazopanib Eye Drops 10 mg/mL QID
Only the study eye (one eye) per participant enrolled in the study received pazopanib eye drops 10 mg/mL four times daily. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week Treatment Period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
OG006
Ranibizumab Injections Active Open-label Control Arm
Participants enrolled in this arm received no eye drops. They received a 0.20 mL to 0.23 mL fill of 10 mg/mL Ranibizumab injection once every four weeks throughout the entire 52 weeks of the study.
Units
Counts
Participants
OG00073
OG00172
OG00274
OG00373
OG00473
OG00572
OG00673
Title
Denominators
Categories
Week 4, Study Eye
ParticipantsOG00071
ParticipantsOG00171
ParticipantsOG00274
ParticipantsOG00372
ParticipantsOG00473
ParticipantsOG00571
ParticipantsOG00673
Title
Measurements
within 5 letters
OG00049
OG00149
OG00257
OG003
Week 4, Fellow Eye
ParticipantsOG00072
ParticipantsOG00171
ParticipantsOG00273
ParticipantsOG00372
Week 8, Study Eye
ParticipantsOG00071
ParticipantsOG00170
ParticipantsOG00274
ParticipantsOG00373
Week 8, Fellow Eye
ParticipantsOG00072
ParticipantsOG00170
ParticipantsOG00273
ParticipantsOG00373
Week 12, Study Eye
ParticipantsOG00071
ParticipantsOG00168
ParticipantsOG00274
ParticipantsOG00372
Week 12, Fellow Eye
ParticipantsOG00072
ParticipantsOG00168
ParticipantsOG00273
ParticipantsOG00371
Week 16, Study Eye
ParticipantsOG00071
ParticipantsOG00168
ParticipantsOG00273
ParticipantsOG00370
Week 16, Fellow Eye
ParticipantsOG00072
ParticipantsOG00168
ParticipantsOG00272
ParticipantsOG00370
Week 20, Study Eye
ParticipantsOG00069
ParticipantsOG00168
ParticipantsOG00271
ParticipantsOG00370
Week 20, Fellow Eye
ParticipantsOG00070
ParticipantsOG00168
ParticipantsOG00270
ParticipantsOG00369
Week 24, Study Eye
ParticipantsOG00069
ParticipantsOG00168
ParticipantsOG00272
ParticipantsOG00369
Week 24, Fellow Eye
ParticipantsOG00070
ParticipantsOG00168
ParticipantsOG00271
ParticipantsOG00369
Week 28, Study Eye
ParticipantsOG00068
ParticipantsOG00168
ParticipantsOG00271
ParticipantsOG00369
Week 28, Fellow Eye
ParticipantsOG00069
ParticipantsOG00168
ParticipantsOG00270
ParticipantsOG00368
Week 32, Study Eye
ParticipantsOG00067
ParticipantsOG00168
ParticipantsOG00270
ParticipantsOG00369
Week 32, Fellow Eye
ParticipantsOG00068
ParticipantsOG00168
ParticipantsOG00269
ParticipantsOG00369
Week 36, Study Eye
ParticipantsOG00065
ParticipantsOG00166
ParticipantsOG00271
ParticipantsOG00368
Week 36, Fellow Eye
ParticipantsOG00067
ParticipantsOG00166
ParticipantsOG00270
ParticipantsOG00368
Week 40, Study Eye
ParticipantsOG00067
ParticipantsOG00168
ParticipantsOG00270
ParticipantsOG00368
Week 40, Fellow Eye
ParticipantsOG00068
ParticipantsOG00168
ParticipantsOG00269
ParticipantsOG00368
Week 44, Study Eye
ParticipantsOG00066
ParticipantsOG00168
ParticipantsOG00270
ParticipantsOG00367
Week 44, Fellow Eye
ParticipantsOG00067
ParticipantsOG00168
ParticipantsOG00269
ParticipantsOG00367
Week 48, Study Eye
ParticipantsOG00064
ParticipantsOG00167
ParticipantsOG00271
ParticipantsOG00367
Week 48, Fellow Eye
ParticipantsOG00065
ParticipantsOG00167
ParticipantsOG00270
ParticipantsOG00366
Week 52, Study Eye
ParticipantsOG00064
ParticipantsOG00166
ParticipantsOG00271
ParticipantsOG00367
Week 52, Fellow Eye
ParticipantsOG00064
ParticipantsOG00166
ParticipantsOG00270
ParticipantsOG00367
OG002
Pazopanib Eye Drops 5 mg/mL QID
Only the study eye (one eye) per participant enrolled in the study received pazopanib eye drops 5 mg/mL QID. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week Treatment Period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
OG003
Pazopanib Eye Drops 10 mg/mL BID
Only the study eye (one eye) per participant enrolled in the study received pazopanib eye drops 10 mg/mL twice daily. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week Treatment Period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
OG004
Pazopanib Eye Drops 10 mg/mL TID
Only the study eye (one eye) per participant enrolled in the study received pazopanib eye drops 10 mg/mL thrice daily. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week Treatment Period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
OG005
Pazopanib Eye Drops 10 mg/mL QID
Only the study eye (one eye) per participant enrolled in the study received pazopanib eye drops 10 mg/mL four times daily. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week Treatment Period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
OG006
Ranibizumab Injections Active Open-label Control Arm
Participants enrolled in this arm received no eye drops. They received a 0.20 mL to 0.23 mL fill of 10 mg/mL Ranibizumab injection once every four weeks throughout the entire 52 weeks of the study.
Units
Counts
Participants
OG00073
OG00172
OG00274
OG00373
OG00473
OG00572
OG00673
Title
Denominators
Categories
Title
Measurements
OG00025
OG00119
OG00220
OG00318
OG00421
OG00523
OG00615
OG001
Pazopanib Eye Drops 5 mg/mL TID
Only the study eye (one eye) per participant enrolled in the study received pazopanib eye drops 5 mg/mL TID. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week Treatment Period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
OG002
Pazopanib Eye Drops 5 mg/mL QID
Only the study eye (one eye) per participant enrolled in the study received pazopanib eye drops 5 mg/mL QID. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week Treatment Period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
OG003
Pazopanib Eye Drops 10 mg/mL BID
Only the study eye (one eye) per participant enrolled in the study received pazopanib eye drops 10 mg/mL twice daily. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week Treatment Period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
OG004
Pazopanib Eye Drops 10 mg/mL TID
Only the study eye (one eye) per participant enrolled in the study received pazopanib eye drops 10 mg/mL thrice daily. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week Treatment Period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
OG005
Pazopanib Eye Drops 10 mg/mL QID
Only the study eye (one eye) per participant enrolled in the study received pazopanib eye drops 10 mg/mL four times daily. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week Treatment Period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
OG006
Ranibizumab Injections Active Open-label Control Arm
Participants enrolled in this arm received no eye drops. They received a 0.20 mL to 0.23 mL fill of 10 mg/mL Ranibizumab injection once every four weeks throughout the entire 52 weeks of the study.
Units
Counts
Participants
OG00073
OG00172
OG00274
OG00373
OG00473
OG00572
OG00673
Title
Denominators
Categories
Subgroup-Genotype, Week 28, CC
ParticipantsOG00022
ParticipantsOG00119
ParticipantsOG00221
ParticipantsOG00325
ParticipantsOG00418
ParticipantsOG00522
ParticipantsOG00621
Title
Measurements
OG00010.0± 55.29
OG00112.3± 48.05
OG0023.4± 56.23
OG003
Subgroup-Genotype, Week 28, CT
ParticipantsOG00032
ParticipantsOG00137
ParticipantsOG00230
ParticipantsOG00324
Subgroup-Genotype, Week 52, CC
ParticipantsOG00021
ParticipantsOG00119
ParticipantsOG00221
ParticipantsOG00323
Subgroup-Genotype, Week 52, CT
ParticipantsOG00029
ParticipantsOG00135
ParticipantsOG00230
ParticipantsOG00322
Subgroup-Pre-amendment 3, Week 28
ParticipantsOG0008
ParticipantsOG00112
ParticipantsOG00212
ParticipantsOG00310
Subgroup-Post-amendment 3, Week 28
ParticipantsOG00061
ParticipantsOG00156
ParticipantsOG00259
ParticipantsOG00359
Subgroup-Pre-amendment 3, Week 52
ParticipantsOG0007
ParticipantsOG00112
ParticipantsOG00212
ParticipantsOG0039
Subgroup-Post-amendment 3, Week 52
ParticipantsOG00057
ParticipantsOG00154
ParticipantsOG00259
ParticipantsOG00356
Only the study eye (one eye) per participant enrolled in the study received pazopanib eye drops 5 mg/mL TID. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week Treatment Period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
OG002
Pazopanib Eye Drops 5 mg/mL QID
Only the study eye (one eye) per participant enrolled in the study received pazopanib eye drops 5 mg/mL QID. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week Treatment Period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
OG003
Pazopanib Eye Drops 10 mg/mL BID
Only the study eye (one eye) per participant enrolled in the study received pazopanib eye drops 10 mg/mL twice daily. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week Treatment Period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
OG004
Pazopanib Eye Drops 10 mg/mL TID
Only the study eye (one eye) per participant enrolled in the study received pazopanib eye drops 10 mg/mL thrice daily. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week Treatment Period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
OG005
Pazopanib Eye Drops 10 mg/mL QID
Only the study eye (one eye) per participant enrolled in the study received pazopanib eye drops 10 mg/mL four times daily. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week Treatment Period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
Units
Counts
Participants
OG00073
OG00172
OG00274
OG00373
OG00473
OG00572
Title
Denominators
Categories
Week 4
ParticipantsOG00064
ParticipantsOG00159
ParticipantsOG00266
ParticipantsOG00367
ParticipantsOG00461
ParticipantsOG00562
Title
Measurements
OG00049
OG00133
OG00254
OG003
Week 12
ParticipantsOG00060
ParticipantsOG00160
ParticipantsOG00268
ParticipantsOG00366
Week 16
ParticipantsOG0001
ParticipantsOG0010
ParticipantsOG0021
ParticipantsOG0030
Week 20
ParticipantsOG00073
ParticipantsOG00172
ParticipantsOG00274
ParticipantsOG00373
Week 28
ParticipantsOG00054
ParticipantsOG00158
ParticipantsOG00262
ParticipantsOG00360
Week 32
ParticipantsOG00073
ParticipantsOG00172
ParticipantsOG00274
ParticipantsOG0031
Week 44
ParticipantsOG00073
ParticipantsOG0011
ParticipantsOG00274
ParticipantsOG00373
Week 52
ParticipantsOG00050
ParticipantsOG00152
ParticipantsOG00261
ParticipantsOG00355
OG002
Pazopanib Eye Drops 5 mg/mL QID
Only the study eye (one eye) per participant enrolled in the study received pazopanib eye drops 5 mg/mL QID. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week Treatment Period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
OG003
Pazopanib Eye Drops 10 mg/mL BID
Only the study eye (one eye) per participant enrolled in the study received pazopanib eye drops 10 mg/mL twice daily. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week Treatment Period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
OG004
Pazopanib Eye Drops 10 mg/mL TID
Only the study eye (one eye) per participant enrolled in the study received pazopanib eye drops 10 mg/mL thrice daily. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week Treatment Period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
OG005
Pazopanib Eye Drops 10 mg/mL QID
Only the study eye (one eye) per participant enrolled in the study received pazopanib eye drops 10 mg/mL four times daily. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week Treatment Period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
OG006
Ranibizumab Injections Active Open-label Control Arm
Participants enrolled in this arm received no eye drops. They received a 0.20 mL to 0.23 mL fill of 10 mg/mL Ranibizumab injection once every four weeks throughout the entire 52 weeks of the study.
Units
Counts
Participants
OG00073
OG00172
OG00274
OG00373
OG00473
OG00572
OG00673
Title
Denominators
Categories
Week 28
Title
Measurements
OG0000.10± 0.113
OG0010.16± 0.114
OG0020.09± 0.111
OG0030.06± 0.114
OG004-0.05± 0.112
OG0050.13± 0.114
OG006-0.08± 0.118
Week 52
Title
Measurements
OG0000.10± 0.134
OG0010.13± 0.133
OG0020.08± 0.129
OG003
OG002
Pazopanib Eye Drops 5 mg/mL QID
Only the study eye (one eye) per participant enrolled in the study received pazopanib eye drops 5 mg/mL QID. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week Treatment Period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
OG003
Pazopanib Eye Drops 10 mg/mL BID
Only the study eye (one eye) per participant enrolled in the study received pazopanib eye drops 10 mg/mL twice daily. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week Treatment Period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
OG004
Pazopanib Eye Drops 10 mg/mL TID
Only the study eye (one eye) per participant enrolled in the study received pazopanib eye drops 10 mg/mL thrice daily. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week Treatment Period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
OG005
Pazopanib Eye Drops 10 mg/mL QID
Only the study eye (one eye) per participant enrolled in the study received pazopanib eye drops 10 mg/mL four times daily. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week Treatment Period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
OG006
Ranibizumab Injections Active Open-label Control Arm
Participants enrolled in this arm received no eye drops. They received a 0.20 mL to 0.23 mL fill of 10 mg/mL Ranibizumab injection once every four weeks throughout the entire 52 weeks of the study.
Units
Counts
Participants
OG00073
OG00172
OG00274
OG00373
OG00473
OG00572
OG00673
Title
Denominators
Categories
Week 28
Title
Measurements
OG0000.18± 0.131
OG0010.32± 0.132
OG0020.23± 0.129
OG0030.12± 0.132
OG0040.00± 0.130
OG0050.13± 0.132
OG006-0.13± 0.137
Week 52
Title
Measurements
OG0000.40± 0.152
OG0010.51± 0.151
OG0020.09± 0.146
OG003
Only the study eye (one eye) per participant enrolled in the study received pazopanib eye drops 5 mg/mL TID. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week Treatment Period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
OG002
Pazopanib Eye Drops 5 mg/mL QID
Only the study eye (one eye) per participant enrolled in the study received pazopanib eye drops 5 mg/mL QID. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week Treatment Period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
OG003
Pazopanib Eye Drops 10 mg/mL BID
Only the study eye (one eye) per participant enrolled in the study received pazopanib eye drops 10 mg/mL twice daily. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week Treatment Period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
OG004
Pazopanib Eye Drops 10 mg/mL TID
Only the study eye (one eye) per participant enrolled in the study received pazopanib eye drops 10 mg/mL thrice daily. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week Treatment Period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
OG005
Pazopanib Eye Drops 10 mg/mL QID
Only the study eye (one eye) per participant enrolled in the study received pazopanib eye drops 10 mg/mL four times daily. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week Treatment Period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
OG006
Ranibizumab Injections Active Open-label Control Arm
Participants enrolled in this arm received no eye drops. They received a 0.20 mL to 0.23 mL fill of 10 mg/mL Ranibizumab injection once every four weeks throughout the entire 52 weeks of the study.
Units
Counts
Participants
OG00073
OG00172
OG00274
OG00373
OG00473
OG00572
OG00673
Title
Denominators
Categories
Week 28
Title
Measurements
OG000-0.33± 0.150
OG001-0.27± 0.151
OG002-0.32± 0.148
OG003-0.40± 0.151
OG004-0.61± 0.149
OG005-0.33± 0.151
OG006-0.60± 0.156
Week 52
Title
Measurements
OG000-0.40± 0.177
OG001-0.45± 0.176
OG002-0.19± 0.171
OG003
OG002
Pazopanib Eye Drops 5 mg/mL QID
Only the study eye (one eye) per participant enrolled in the study received pazopanib eye drops 5 mg/mL QID. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week Treatment Period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
OG003
Pazopanib Eye Drops 10 mg/mL BID
Only the study eye (one eye) per participant enrolled in the study received pazopanib eye drops 10 mg/mL twice daily. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week Treatment Period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
OG004
Pazopanib Eye Drops 10 mg/mL TID
Only the study eye (one eye) per participant enrolled in the study received pazopanib eye drops 10 mg/mL thrice daily. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week Treatment Period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
OG005
Pazopanib Eye Drops 10 mg/mL QID
Only the study eye (one eye) per participant enrolled in the study received pazopanib eye drops 10 mg/mL four times daily. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week Treatment Period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
OG006
Ranibizumab Injections Active Open-label Control Arm
Participants enrolled in this arm received no eye drops. They received a 0.20 mL to 0.23 mL fill of 10 mg/mL Ranibizumab injection once every four weeks throughout the entire 52 weeks of the study.
Units
Counts
Participants
OG00073
OG00172
OG00274
OG00373
OG00473
OG00572
OG00673
Title
Denominators
Categories
Week 28
Title
Measurements
OG000-0.30± 0.259
OG001-0.28± 0.264
OG002-0.14± 0.255
OG003-0.55± 0.261
OG004-0.64± 0.261
OG005-0.46± 0.264
OG006-0.95± 0.273
Week 52
Title
Measurements
OG000-0.52± 0.317
OG001-0.76± 0.315
OG002-0.79± 0.300
OG003
OG002
Pazopanib Eye Drops 5 mg/mL QID
Only the study eye (one eye) per participant enrolled in the study received pazopanib eye drops 5 mg/mL QID. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week Treatment Period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
OG003
Pazopanib Eye Drops 10 mg/mL BID
Only the study eye (one eye) per participant enrolled in the study received pazopanib eye drops 10 mg/mL twice daily. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week Treatment Period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
OG004
Pazopanib Eye Drops 10 mg/mL TID
Only the study eye (one eye) per participant enrolled in the study received pazopanib eye drops 10 mg/mL thrice daily. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week Treatment Period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
OG005
Pazopanib Eye Drops 10 mg/mL QID
Only the study eye (one eye) per participant enrolled in the study received pazopanib eye drops 10 mg/mL four times daily. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week Treatment Period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
OG006
Ranibizumab Injections Active Open-label Control Arm
Participants enrolled in this arm received no eye drops. They received a 0.20 mL to 0.23 mL fill of 10 mg/mL Ranibizumab injection once every four weeks throughout the entire 52 weeks of the study.
Units
Counts
Participants
OG00073
OG00172
OG00274
OG00373
OG00473
OG00572
OG00673
Title
Denominators
Categories
Adverse Events (AEs)
Title
Measurements
OG00011
OG00110
OG00212
OG00311
OG00410
OG00511
OG0066
Serious Adverse Events (SAEs)
Title
Measurements
OG00052
OG00134
OG00247
OG003
Only the study eye (one eye) per participant enrolled in the study received pazopanib eye drops 5 mg/mL TID. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week Treatment Period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
OG002
Pazopanib Eye Drops 5 mg/mL QID
Only the study eye (one eye) per participant enrolled in the study received pazopanib eye drops 5 mg/mL QID. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week Treatment Period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
OG003
Pazopanib Eye Drops 10 mg/mL BID
Only the study eye (one eye) per participant enrolled in the study received pazopanib eye drops 10 mg/mL twice daily. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week Treatment Period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
OG004
Pazopanib Eye Drops 10 mg/mL TID
Only the study eye (one eye) per participant enrolled in the study received pazopanib eye drops 10 mg/mL thrice daily. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week Treatment Period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
OG005
Pazopanib Eye Drops 10 mg/mL QID
Only the study eye (one eye) per participant enrolled in the study received pazopanib eye drops 10 mg/mL four times daily. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week Treatment Period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
OG006
Ranibizumab Injections Active Open-label Control Arm
Participants enrolled in this arm received no eye drops. They received a 0.20 mL to 0.23 mL fill of 10 mg/mL Ranibizumab injection once every four weeks throughout the entire 52 weeks of the study.
Units
Counts
Participants
OG00073
OG00172
OG00274
OG00373
OG00473
OG00572
OG00673
Title
Denominators
Categories
Afferent papillary defect present, SE
Title
Measurements
OG0004
OG0012
OG0024
OG0032
OG0041
OG0052
OG0063
Afferent papillary defect present, FE
Title
Measurements
OG0004
OG0011
OG0025
OG003
Eye motility abnormal, SE
Title
Measurements
OG0001
OG0010
OG0020
OG003
Eye motility abnormal, FE
Title
Measurements
OG0001
OG0010
OG0020
OG003
Confrontation visual field abnormal, SE
Title
Measurements
OG0002
OG0011
OG0020
OG003
Confrontation visual field abnormal, FE
Title
Measurements
OG0002
OG0010
OG0022
OG003
Ptosis present, SE
Title
Measurements
OG0002
OG0011
OG0021
OG003
Ptosis present, FE
Title
Measurements
OG0001
OG0013
OG0021
OG003
2-step worsening of Meibomian gland dysfunction,SE
Title
Measurements
OG0000
OG0010
OG0022
OG003
2-step worsening of Meibomian gland dysfunction,FE
Title
Measurements
OG0000
OG0010
OG0024
OG003
2-step worsening of Conjunctival injection, SE
Title
Measurements
OG0002
OG0010
OG0021
OG003
2-step worsening of Conjunctival injection, FE
Title
Measurements
OG0001
OG0011
OG0021
OG003
2-step worsening of Chemosis, SE
Title
Measurements
OG0000
OG0010
OG0020
OG003
2-step worsening of Chemosis, FE
Title
Measurements
OG0000
OG0010
OG0020
OG003
2-step worsening of punctate keratopathy, SE
Title
Measurements
OG0000
OG0010
OG0021
OG003
2-step worsening of punctate keratopathy, FE
Title
Measurements
OG0000
OG0011
OG0022
OG003
2-step worsening of epithelial edema, SE
Title
Measurements
OG0000
OG0010
OG0020
OG003
2-step worsening of epithelial edema, FE
Title
Measurements
OG0000
OG0010
OG0020
OG003
Abnormal postbaseline finding of active opacity,SE
Title
Measurements
OG0001
OG0010
OG0023
OG003
Abnormal postbaseline finding of active opacity,FE
Title
Measurements
OG0002
OG0010
OG0023
OG003
Abnormal post-baseline finding of active edema, SE
Title
Measurements
OG0000
OG0010
OG0020
OG003
Abnormal post-baseline finding of active edema, FE
Title
Measurements
OG0001
OG0010
OG0020
OG003
Grade 1+ of Anterior chamber cell, SE
Title
Measurements
OG0000
OG0011
OG0020
OG003
Grade 1+ of Anterior chamber cell, FE
Title
Measurements
OG0001
OG0011
OG0020
OG003
Anterior chamber hypopyon present, SE
Title
Measurements
OG0000
OG0011
OG0020
OG003
Anterior chamber hypopyon present, FE
Title
Measurements
OG0000
OG0010
OG0022
OG003
Grade 2+ of Anterior chamber flare, SE
Title
Measurements
OG0000
OG0010
OG0020
OG003
Grade 2+ of Anterior chamber flare, FE
Title
Measurements
OG0000
OG0010
OG0020
OG003
2+ increases in Any Lens Opacity, SE
Title
Measurements
OG0004
OG0011
OG0025
OG003
2+ increases in Any Lens Opacity, FE
Title
Measurements
OG0003
OG0011
OG0024
OG003
VA =>15 loss from Baseline or Previous Visit, SE
Title
Measurements
OG00015
OG0018
OG0027
OG003
VA =>15 loss from Baseline or Previous Visit, FE
Title
Measurements
OG00010
OG0015
OG0026
OG003
OG002
Pazopanib Eye Drops 5 mg/mL QID
Only the study eye (one eye) per participant enrolled in the study received pazopanib eye drops 5 mg/mL QID. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week Treatment Period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
OG003
Pazopanib Eye Drops 10 mg/mL BID
Only the study eye (one eye) per participant enrolled in the study received pazopanib eye drops 10 mg/mL twice daily. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week Treatment Period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
OG004
Pazopanib Eye Drops 10 mg/mL TID
Only the study eye (one eye) per participant enrolled in the study received pazopanib eye drops 10 mg/mL thrice daily. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week Treatment Period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
OG005
Pazopanib Eye Drops 10 mg/mL QID
Only the study eye (one eye) per participant enrolled in the study received pazopanib eye drops 10 mg/mL four times daily. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week Treatment Period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
OG006
Ranibizumab Injections Active Open-label Control Arm
Participants enrolled in this arm received no eye drops. They received a 0.20 mL to 0.23 mL fill of 10 mg/mL Ranibizumab injection once every four weeks throughout the entire 52 weeks of the study.
Units
Counts
Participants
OG00073
OG00172
OG00274
OG00373
OG00473
OG00572
OG00673
Title
Denominators
Categories
Any post-baseline IOP >=30 study eye
Title
Measurements
OG0000
OG0010
OG0021
OG0031
OG0040
OG0051
OG0061
IOP Lowering Medication for study eye
Title
Measurements
OG0001
OG0014
OG0025
OG003
IOP Lowering procedure for study eye
Title
Measurements
OG0001
OG0011
OG0020
OG003
Any post-baseline IOP >=30 fellow eye
Title
Measurements
OG0000
OG0010
OG0020
OG003
IOP Lowering Medication for fellow eye
Title
Measurements
OG0002
OG0013
OG0023
OG003
IOP Lowering procedure for fellow eye
Title
Measurements
OG0001
OG0011
OG0021
OG003
OG001
Pazopanib Eye Drops 5 mg/mL TID
Only the study eye (one eye) per participant enrolled in the study received pazopanib eye drops 5 mg/mL TID. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week Treatment Period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
OG002
Pazopanib Eye Drops 5 mg/mL QID
Only the study eye (one eye) per participant enrolled in the study received pazopanib eye drops 5 mg/mL QID. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week Treatment Period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
OG003
Pazopanib Eye Drops 10 mg/mL BID
Only the study eye (one eye) per participant enrolled in the study received pazopanib eye drops 10 mg/mL twice daily. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week Treatment Period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
OG004
Pazopanib Eye Drops 10 mg/mL TID
Only the study eye (one eye) per participant enrolled in the study received pazopanib eye drops 10 mg/mL thrice daily. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week Treatment Period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
OG005
Pazopanib Eye Drops 10 mg/mL QID
Only the study eye (one eye) per participant enrolled in the study received pazopanib eye drops 10 mg/mL four times daily. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week Treatment Period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
OG006
Ranibizumab Injections Active Open-label Control Arm
Participants enrolled in this arm received no eye drops. They received a 0.20 mL to 0.23 mL fill of 10 mg/mL Ranibizumab injection once every four weeks throughout the entire 52 weeks of the study.
Units
Counts
Participants
OG00073
OG00172
OG00274
OG00373
OG00473
OG00572
OG00673
Title
Denominators
Categories
Average diastolic blood pressure, Week 4, High
ParticipantsOG00072
ParticipantsOG00171
ParticipantsOG00274
ParticipantsOG00373
ParticipantsOG00473
ParticipantsOG00571
ParticipantsOG00673
Title
Measurements
OG0000
OG0010
OG0020
OG003
Average diastolic blood pressure, Week 4, Low
ParticipantsOG00072
ParticipantsOG00171
ParticipantsOG00274
ParticipantsOG00373
Average diastolic blood pressure, Week 8, High
ParticipantsOG00072
ParticipantsOG00170
ParticipantsOG00274
ParticipantsOG00373
Average diastolic blood pressure, Week 12, High
ParticipantsOG00072
ParticipantsOG00168
ParticipantsOG00274
ParticipantsOG003
Average diastolic blood pressure, Week 16, High
ParticipantsOG00072
ParticipantsOG00168
ParticipantsOG00273
ParticipantsOG003
Average diastolic blood pressure, Week 20, High
ParticipantsOG00070
ParticipantsOG00168
ParticipantsOG00272
ParticipantsOG003
Average diastolic blood pressure, Week 24, High
ParticipantsOG00070
ParticipantsOG00168
ParticipantsOG00272
ParticipantsOG003
Average diastolic blood pressure, Week 24, Low
ParticipantsOG00070
ParticipantsOG00168
ParticipantsOG00272
ParticipantsOG00369
Average diastolic blood pressure, Week 28, Low
ParticipantsOG00069
ParticipantsOG00168
ParticipantsOG00271
ParticipantsOG00369
Average diastolic blood pressure, Week 32, High
ParticipantsOG00068
ParticipantsOG00168
ParticipantsOG00270
ParticipantsOG003
Average diastolic blood pressure, Week 36, Low
ParticipantsOG00067
ParticipantsOG00166
ParticipantsOG00271
ParticipantsOG003
Average diastolic blood pressure, Week 44, High
ParticipantsOG00067
ParticipantsOG00168
ParticipantsOG00270
ParticipantsOG003
Average diastolic blood pressure, Week 48, High
ParticipantsOG00065
ParticipantsOG00166
ParticipantsOG00271
ParticipantsOG003
Average diastolic blood pressure, Week 52, High
ParticipantsOG00065
ParticipantsOG00166
ParticipantsOG00271
ParticipantsOG003
Average systolic blood pressure, Day 1, High
ParticipantsOG00073
ParticipantsOG00172
ParticipantsOG00274
ParticipantsOG00373
Average systolic blood pressure, Week 4, High
ParticipantsOG00072
ParticipantsOG00171
ParticipantsOG00274
ParticipantsOG00373
Average systolic blood pressure, Week 8, High
ParticipantsOG00072
ParticipantsOG00170
ParticipantsOG00274
ParticipantsOG00373
Average systolic blood pressure, Week 12, High
ParticipantsOG00072
ParticipantsOG00168
ParticipantsOG00274
ParticipantsOG003
Average systolic blood pressure, Week 16, High
ParticipantsOG00072
ParticipantsOG00168
ParticipantsOG00273
ParticipantsOG003
Average systolic blood pressure, Week 20, High
ParticipantsOG00070
ParticipantsOG00168
ParticipantsOG00272
ParticipantsOG003
Average systolic blood pressure, Week 24, High
ParticipantsOG00070
ParticipantsOG00168
ParticipantsOG00272
ParticipantsOG003
Average systolic blood pressure, Week 28, High
ParticipantsOG00069
ParticipantsOG00168
ParticipantsOG00271
ParticipantsOG003
Average systolic blood pressure, Week 32, High
ParticipantsOG00068
ParticipantsOG00168
ParticipantsOG00270
ParticipantsOG003
Average systolic blood pressure, Week 36, High
ParticipantsOG00067
ParticipantsOG00166
ParticipantsOG00271
ParticipantsOG003
Average systolic blood pressure, Week 40, High
ParticipantsOG00068
ParticipantsOG00168
ParticipantsOG00270
ParticipantsOG003
Average systolic blood pressure, Week 44, High
ParticipantsOG00067
ParticipantsOG00168
ParticipantsOG00270
ParticipantsOG003
Average systolic blood pressure, Week 44, Low
ParticipantsOG00067
ParticipantsOG00168
ParticipantsOG00270
ParticipantsOG00373
Average systolic blood pressure, Week 48, High
ParticipantsOG00065
ParticipantsOG00166
ParticipantsOG00271
ParticipantsOG003
Average systolic blood pressure, Week 52, High
ParticipantsOG00065
ParticipantsOG00166
ParticipantsOG00271
ParticipantsOG003
Heart Rate, Week 16, High
ParticipantsOG00071
ParticipantsOG00168
ParticipantsOG00273
ParticipantsOG00370
Heart Rate, Week 20, High
ParticipantsOG00070
ParticipantsOG00168
ParticipantsOG00272
ParticipantsOG00370
Heart Rate, Week 24, High
ParticipantsOG00070
ParticipantsOG00168
ParticipantsOG00272
ParticipantsOG00369
Heart Rate, Week 32, High
ParticipantsOG00068
ParticipantsOG00168
ParticipantsOG00270
ParticipantsOG00369
Heart Rate, Week 36, High
ParticipantsOG00067
ParticipantsOG00166
ParticipantsOG00271
ParticipantsOG00368
Heart Rate, Week 40, High
ParticipantsOG00068
ParticipantsOG00168
ParticipantsOG00270
ParticipantsOG00368
Heart Rate, Week 48, High
ParticipantsOG00065
ParticipantsOG00166
ParticipantsOG00271
ParticipantsOG00368
Only the study eye (one eye) per participant enrolled in the study received pazopanib eye drops 5 mg/mL TID. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week Treatment Period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
OG002
Pazopanib Eye Drops 5 mg/mL QID
Only the study eye (one eye) per participant enrolled in the study received pazopanib eye drops 5 mg/mL QID. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week Treatment Period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
OG003
Pazopanib Eye Drops 10 mg/mL BID
Only the study eye (one eye) per participant enrolled in the study received pazopanib eye drops 10 mg/mL twice daily. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week Treatment Period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
OG004
Pazopanib Eye Drops 10 mg/mL TID
Only the study eye (one eye) per participant enrolled in the study received pazopanib eye drops 10 mg/mL thrice daily. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week Treatment Period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
OG005
Pazopanib Eye Drops 10 mg/mL QID
Only the study eye (one eye) per participant enrolled in the study received pazopanib eye drops 10 mg/mL four times daily. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week Treatment Period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
OG006
Ranibizumab Injections Active Open-label Control Arm
Participants enrolled in this arm received no eye drops. They received a 0.20 mL to 0.23 mL fill of 10 mg/mL Ranibizumab injection once every four weeks throughout the entire 52 weeks of the study.
Units
Counts
Participants
OG00073
OG00172
OG00274
OG00373
OG00473
OG00572
OG00673
Title
Denominators
Categories
Week 4, Abnormal - Clinically significant
ParticipantsOG00072
ParticipantsOG00170
ParticipantsOG00274
ParticipantsOG00373
ParticipantsOG00472
ParticipantsOG00572
ParticipantsOG00671
Title
Measurements
OG00010
OG00111
OG00213
OG003
Week 4, Abnormal - Not Clinically significant
ParticipantsOG00072
ParticipantsOG00170
ParticipantsOG00274
ParticipantsOG00373
Week 28, Abnormal - Clinically significant
ParticipantsOG00052
ParticipantsOG00149
ParticipantsOG00254
ParticipantsOG00352
Week 28, Abnormal - Not Clinically significant
ParticipantsOG00052
ParticipantsOG00149
ParticipantsOG00254
ParticipantsOG00352
Week 44, Abnormal - Clinically significant
ParticipantsOG0000
ParticipantsOG0011
ParticipantsOG0020
ParticipantsOG0030
Week 44, Abnormal - Not Clinically significant
ParticipantsOG0000
ParticipantsOG0011
ParticipantsOG0020
ParticipantsOG0030
Week 52, Abnormal - Clinically significant
ParticipantsOG00057
ParticipantsOG00154
ParticipantsOG00263
ParticipantsOG00359
Week 52, Abnormal - Not Clinically significant
ParticipantsOG00057
ParticipantsOG00154
ParticipantsOG00263
ParticipantsOG00359
Pazopanib Eye Drops 5 mg/mL TID
Only the study eye (one eye) per participant enrolled in the study received pazopanib eye drops 5 mg/mL TID. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week Treatment Period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
OG002
Pazopanib Eye Drops 5 mg/mL QID
Only the study eye (one eye) per participant enrolled in the study received pazopanib eye drops 5 mg/mL QID. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week Treatment Period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
OG003
Pazopanib Eye Drops 10 mg/mL BID
Only the study eye (one eye) per participant enrolled in the study received pazopanib eye drops 10 mg/mL twice daily. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week Treatment Period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
OG004
Pazopanib Eye Drops 10 mg/mL TID
Only the study eye (one eye) per participant enrolled in the study received pazopanib eye drops 10 mg/mL thrice daily. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week Treatment Period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
OG005
Pazopanib Eye Drops 10 mg/mL QID
Only the study eye (one eye) per participant enrolled in the study received pazopanib eye drops 10 mg/mL four times daily. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week Treatment Period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
OG006
Ranibizumab Injections Active Open-label Control Arm
Participants enrolled in this arm received no eye drops. They received a 0.20 mL to 0.23 mL fill of 10 mg/mL Ranibizumab injection once every four weeks throughout the entire 52 weeks of the study.
Units
Counts
Participants
OG00073
OG00172
OG00274
OG00373
OG00473
OG00572
OG00673
Title
Denominators
Categories
ALT, Week 4, High
ParticipantsOG00071
ParticipantsOG00170
ParticipantsOG00272
ParticipantsOG00370
ParticipantsOG00471
ParticipantsOG00570
ParticipantsOG00673
Title
Measurements
OG0000
OG0010
OG0022
OG003
ALT, Week 8, High
ParticipantsOG00069
ParticipantsOG00168
ParticipantsOG00272
ParticipantsOG00369
ALT, Week 12, High
ParticipantsOG00070
ParticipantsOG00167
ParticipantsOG00271
ParticipantsOG00370
ALT, Week 52, High
ParticipantsOG00065
ParticipantsOG00162
ParticipantsOG00268
ParticipantsOG00363
Albumin, Week 4, Low
ParticipantsOG00071
ParticipantsOG00170
ParticipantsOG00272
ParticipantsOG00370
Alkaline Phosphatase, Week 12, High
ParticipantsOG00070
ParticipantsOG00167
ParticipantsOG00271
ParticipantsOG00370
Alkaline Phosphatase, Week 16, High
ParticipantsOG00065
ParticipantsOG00166
ParticipantsOG00270
ParticipantsOG00366
Alkaline Phosphatase, Week 20, High
ParticipantsOG00068
ParticipantsOG00166
ParticipantsOG00272
ParticipantsOG00370
Alkaline Phosphatase, Week 24, High
ParticipantsOG00068
ParticipantsOG00164
ParticipantsOG00272
ParticipantsOG00368
AST, Week 8, High
ParticipantsOG00069
ParticipantsOG00168
ParticipantsOG00272
ParticipantsOG00369
AST, Week 12, High
ParticipantsOG00070
ParticipantsOG00167
ParticipantsOG00270
ParticipantsOG00369
AST, Week 16, High
ParticipantsOG00064
ParticipantsOG00167
ParticipantsOG00271
ParticipantsOG00367
AST, Week 20, High
ParticipantsOG00068
ParticipantsOG00166
ParticipantsOG00272
ParticipantsOG00370
AST, Week 48, High
ParticipantsOG00065
ParticipantsOG00164
ParticipantsOG00266
ParticipantsOG00363
Calcium, Day 1, High
ParticipantsOG00072
ParticipantsOG00170
ParticipantsOG00270
ParticipantsOG00369
Calcium, Week 4, High
ParticipantsOG00071
ParticipantsOG00170
ParticipantsOG00272
ParticipantsOG00370
Calcium, Week 12, High
ParticipantsOG00069
ParticipantsOG00166
ParticipantsOG00270
ParticipantsOG00369
Calcium, Week 28, High
ParticipantsOG00067
ParticipantsOG00165
ParticipantsOG00267
ParticipantsOG00367
Calcium, Week 52, Low
ParticipantsOG00065
ParticipantsOG00161
ParticipantsOG00268
ParticipantsOG00363
Bicarbonate, Day 1, High
ParticipantsOG00072
ParticipantsOG00170
ParticipantsOG00270
ParticipantsOG00369
Bicarbonate, Week4, Low
ParticipantsOG00071
ParticipantsOG00170
ParticipantsOG00272
ParticipantsOG00370
Bicarbonate, Week 8, Low
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0021
ParticipantsOG0032
Bicarbonate, Week 12, Low
ParticipantsOG00069
ParticipantsOG00166
ParticipantsOG00270
ParticipantsOG00369
Bicarbonate, Week 28, Low
ParticipantsOG00067
ParticipantsOG00165
ParticipantsOG00267
ParticipantsOG00367
Bicarbonate, Week 32, Low
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0022
ParticipantsOG0030
Bicarbonate, Week 40, Low
ParticipantsOG00065
ParticipantsOG00163
ParticipantsOG00268
ParticipantsOG00365
Bicarbonate, Week 52, Low
ParticipantsOG00065
ParticipantsOG00161
ParticipantsOG00268
ParticipantsOG00363
Creatinine, Day 1, High
ParticipantsOG00072
ParticipantsOG00171
ParticipantsOG00270
ParticipantsOG00370
Creatinine, Week 4, High
ParticipantsOG00071
ParticipantsOG00170
ParticipantsOG00272
ParticipantsOG00370
Creatinine, Week 12, High
ParticipantsOG00069
ParticipantsOG00166
ParticipantsOG00271
ParticipantsOG00370
Creatinine, Week 28, High
ParticipantsOG00067
ParticipantsOG00166
ParticipantsOG00269
ParticipantsOG00367
Creatinine, Week 52, High
ParticipantsOG00065
ParticipantsOG00162
ParticipantsOG00268
ParticipantsOG00362
Glucose, Day 1, High
ParticipantsOG00072
ParticipantsOG00171
ParticipantsOG00270
ParticipantsOG00370
Glucose, Day 1, Low
ParticipantsOG00072
ParticipantsOG00171
ParticipantsOG00270
ParticipantsOG00370
Glucose, Week 4, High
ParticipantsOG00071
ParticipantsOG00170
ParticipantsOG00272
ParticipantsOG00370
Glucose, Week 4, Low
ParticipantsOG00071
ParticipantsOG00170
ParticipantsOG00272
ParticipantsOG00370
Glucose, Week 8, High
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0021
ParticipantsOG0032
Glucose, Week 12, High
ParticipantsOG00069
ParticipantsOG00166
ParticipantsOG00271
ParticipantsOG00370
Glucose, Week 12, Low
ParticipantsOG00069
ParticipantsOG00166
ParticipantsOG00271
ParticipantsOG00370
Glucose, Week 28, High
ParticipantsOG00067
ParticipantsOG00166
ParticipantsOG00269
ParticipantsOG00367
Glucose, Week 28, Low
ParticipantsOG00067
ParticipantsOG00166
ParticipantsOG00269
ParticipantsOG00367
Glucose, Week 32, High
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0022
ParticipantsOG0030
Glucose, Week 36, High
ParticipantsOG0000
ParticipantsOG0011
ParticipantsOG0020
ParticipantsOG0030
Glucose, Week 40, High
ParticipantsOG00065
ParticipantsOG00163
ParticipantsOG00268
ParticipantsOG00365
Glucose, Week 40, Low
ParticipantsOG00065
ParticipantsOG00163
ParticipantsOG00268
ParticipantsOG00365
Glucose, Week 52, High
ParticipantsOG00065
ParticipantsOG00162
ParticipantsOG00268
ParticipantsOG00363
Haemoglobin, Week 8, High
ParticipantsOG0001
ParticipantsOG0014
ParticipantsOG0021
ParticipantsOG0032
Lymphocytes, Day 1, Low
ParticipantsOG00069
ParticipantsOG00170
ParticipantsOG00272
ParticipantsOG00371
Lymphocytes, Week 4, Low
ParticipantsOG00070
ParticipantsOG00165
ParticipantsOG00271
ParticipantsOG00371
Lymphocytes, Week 12, Low
ParticipantsOG00070
ParticipantsOG00164
ParticipantsOG00271
ParticipantsOG00369
Lymphocytes, Week 28, Low
ParticipantsOG00066
ParticipantsOG00166
ParticipantsOG00269
ParticipantsOG00366
Lymphocytes, Week 40, Low
ParticipantsOG00064
ParticipantsOG00164
ParticipantsOG00266
ParticipantsOG00367
Lymphocytes, Week 52, Low
ParticipantsOG00065
ParticipantsOG00166
ParticipantsOG00266
ParticipantsOG00364
Platelet count, Day 1, High
ParticipantsOG00068
ParticipantsOG00169
ParticipantsOG00272
ParticipantsOG00371
Platelet count, Day 1, Low
ParticipantsOG00068
ParticipantsOG00169
ParticipantsOG00272
ParticipantsOG00371
Platelet count, Week 4, High
ParticipantsOG00069
ParticipantsOG00164
ParticipantsOG00269
ParticipantsOG00370
Platelet count, Week 4, Low
ParticipantsOG00069
ParticipantsOG00164
ParticipantsOG00269
ParticipantsOG00370
Platelet count, Week 12, High
ParticipantsOG00070
ParticipantsOG00161
ParticipantsOG00271
ParticipantsOG00369
Platelet count, Week 12, Low
ParticipantsOG00070
ParticipantsOG00161
ParticipantsOG00271
ParticipantsOG00369
Platelet count, Week 28, High
ParticipantsOG00064
ParticipantsOG00166
ParticipantsOG00268
ParticipantsOG00366
Platelet count, Week 28, Low
ParticipantsOG00064
ParticipantsOG00166
ParticipantsOG00268
ParticipantsOG00366
Platelet count, Week 40, High
ParticipantsOG00063
ParticipantsOG00164
ParticipantsOG00267
ParticipantsOG00367
Platelet count, Week 44, High
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0020
ParticipantsOG0030
Platelet count, Week 52, High
ParticipantsOG00065
ParticipantsOG00166
ParticipantsOG00267
ParticipantsOG00366
Potassium, Day 1, High
ParticipantsOG00072
ParticipantsOG00170
ParticipantsOG00270
ParticipantsOG00369
Potassium, Day 1, Low
ParticipantsOG00072
ParticipantsOG00170
ParticipantsOG00270
ParticipantsOG00369
Potassium, Week 4, High
ParticipantsOG00071
ParticipantsOG00170
ParticipantsOG00272
ParticipantsOG00370
Potassium, Week 4, Low
ParticipantsOG00071
ParticipantsOG00170
ParticipantsOG00272
ParticipantsOG00370
Potassium, Week 12, High
ParticipantsOG00069
ParticipantsOG00166
ParticipantsOG00270
ParticipantsOG00369
Potassium, Week 12, Low
ParticipantsOG00069
ParticipantsOG00166
ParticipantsOG00270
ParticipantsOG00369
Potassium, Week 28, High
ParticipantsOG00067
ParticipantsOG00165
ParticipantsOG00267
ParticipantsOG00367
Potassium, Week 40, High
ParticipantsOG00065
ParticipantsOG00163
ParticipantsOG00268
ParticipantsOG00365
Potassium, Week 52, High
ParticipantsOG00065
ParticipantsOG00161
ParticipantsOG00268
ParticipantsOG00362
Sodium, Week 12, High
ParticipantsOG00069
ParticipantsOG00166
ParticipantsOG00271
ParticipantsOG00370
Sodium, Week 40, Low
ParticipantsOG00065
ParticipantsOG00163
ParticipantsOG00267
ParticipantsOG00365
Sodium, Week 52, Low
ParticipantsOG00065
ParticipantsOG00162
ParticipantsOG00268
ParticipantsOG00362
TSH, Day 1, High
ParticipantsOG00059
ParticipantsOG00162
ParticipantsOG00263
ParticipantsOG00363
TSH, Week 12, High
ParticipantsOG00059
ParticipantsOG00162
ParticipantsOG00263
ParticipantsOG00363
TSH, Week 24, High
ParticipantsOG00064
ParticipantsOG00164
ParticipantsOG00266
ParticipantsOG00362
TSH, Week 36, High
ParticipantsOG00065
ParticipantsOG00164
ParticipantsOG00263
ParticipantsOG00360
TSH, Week 52, High
ParticipantsOG00062
ParticipantsOG00158
ParticipantsOG00262
ParticipantsOG00363
Total Bilirubin, Week 24, High
ParticipantsOG00068
ParticipantsOG00164
ParticipantsOG00272
ParticipantsOG00368
Total Bilirubin, Week 32, High
ParticipantsOG00067
ParticipantsOG00164
ParticipantsOG00266
ParticipantsOG00364
Total Bilirubin, Week 44, High
ParticipantsOG00062
ParticipantsOG00163
ParticipantsOG00269
ParticipantsOG00365
Total Neutrophils, Day 1, Low
ParticipantsOG00069
ParticipantsOG00170
ParticipantsOG00272
ParticipantsOG00371
Total Neutrophils, Week 4, Low
ParticipantsOG00070
ParticipantsOG00165
ParticipantsOG00271
ParticipantsOG00371
Total Neutrophils, Week 12, Low
ParticipantsOG00070
ParticipantsOG00164
ParticipantsOG00271
ParticipantsOG00369
Total Neutrophils, Week 32, Low
ParticipantsOG0002
ParticipantsOG0011
ParticipantsOG0020
ParticipantsOG0030
Total Neutrophils, Week 40, Low
ParticipantsOG00064
ParticipantsOG00164
ParticipantsOG00266
ParticipantsOG00367
Total Neutrophils, Week 52, Low
ParticipantsOG00065
ParticipantsOG00166
ParticipantsOG00266
ParticipantsOG00364
BUN, Day 1, High
ParticipantsOG00072
ParticipantsOG00171
ParticipantsOG00270
ParticipantsOG00370
BUN, Week 4, High
ParticipantsOG00071
ParticipantsOG00170
ParticipantsOG00272
ParticipantsOG00370
BUN, Week 12, High
ParticipantsOG00069
ParticipantsOG00166
ParticipantsOG00271
ParticipantsOG00370
BUN, Week 16, High
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0021
ParticipantsOG0031
BUN, Week 28, High
ParticipantsOG00067
ParticipantsOG00166
ParticipantsOG00269
ParticipantsOG00367
BUN, Week 40, High
ParticipantsOG00065
ParticipantsOG00163
ParticipantsOG00268
ParticipantsOG00365
WBC, DAy 1, Low
ParticipantsOG00069
ParticipantsOG00170
ParticipantsOG00272
ParticipantsOG00371
WBC, Week 28, Low
ParticipantsOG00066
ParticipantsOG00166
ParticipantsOG00269
ParticipantsOG00367
WBC, Week 52, High
ParticipantsOG00065
ParticipantsOG00166
ParticipantsOG00266
ParticipantsOG00365
OG002
Pazopanib Eye Drops 5 mg/mL QID
Only the study eye (one eye) per participant enrolled in the study received pazopanib eye drops 5 mg/mL QID. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week Treatment Period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
OG003
Pazopanib Eye Drops 10 mg/mL BID
Only the study eye (one eye) per participant enrolled in the study received pazopanib eye drops 10 mg/mL twice daily. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week Treatment Period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
OG004
Pazopanib Eye Drops 10 mg/mL TID
Only the study eye (one eye) per participant enrolled in the study received pazopanib eye drops 10 mg/mL thrice daily. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week Treatment Period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
OG005
Pazopanib Eye Drops 10 mg/mL QID
Only the study eye (one eye) per participant enrolled in the study received pazopanib eye drops 10 mg/mL four times daily. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week Treatment Period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
OG006
Ranibizumab Injections Active Open-label Control Arm
Participants enrolled in this arm received no eye drops. They received a 0.20 mL to 0.23 mL fill of 10 mg/mL Ranibizumab injection once every four weeks throughout the entire 52 weeks of the study.
Units
Counts
Participants
OG00073
OG00172
OG00274
OG00373
OG00473
OG00572
OG00673
Title
Denominators
Categories
Week 4
ParticipantsOG00071
ParticipantsOG00168
ParticipantsOG00272
ParticipantsOG00367
ParticipantsOG00472
ParticipantsOG00569
ParticipantsOG00672
Title
Measurements
OG0007
OG0013
OG0025
OG003
Week 8
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0022
ParticipantsOG0032
Week 16
ParticipantsOG0001
ParticipantsOG0010
ParticipantsOG0022
ParticipantsOG0030
Week 28
ParticipantsOG00061
ParticipantsOG00168
ParticipantsOG00270
ParticipantsOG00368
Week 32
ParticipantsOG0003
ParticipantsOG0012
ParticipantsOG0020
ParticipantsOG0030
Week 52
ParticipantsOG00060
ParticipantsOG00164
ParticipantsOG00269
ParticipantsOG00365
OG002
Pazopanib Eye Drops 10 mg/mL BID
Only the study eye (one eye) per participant enrolled in the study received pazopanib eye drops 10 mg/mL twice daily. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week Treatment Period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
OG003
Pazopanib Eye Drops 10 mg/mL TID
Only the study eye (one eye) per participant enrolled in the study received pazopanib eye drops 10 mg/mL thrice daily. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week Treatment Period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
OG004
Pazopanib Eye Drops 10 mg/mL QID
Only the study eye (one eye) per participant enrolled in the study received pazopanib eye drops 10 mg/mL four times daily. Participants in this treatment arm were educated on the packaging and labeling of the eye drop, required refrigerated storage conditions, and proper dosing method. The study staff witnessed participants self-administering the first dose of the eye drop. Caregiver assistance was permitted. This witnessed dose occurred in the clinic on Day 1 of treatment. Participants continued to administer the eye drop daily for the duration of the 52-week Treatment Period. Ranibizumab IP injection was given whenever re-injection was necessary throughout the study.
Units
Counts
Participants
OG00072
OG00174
OG00273
OG00373
OG00472
Title
Denominators
Categories
Week 4
ParticipantsOG00067
ParticipantsOG00172
ParticipantsOG00271
ParticipantsOG00370
ParticipantsOG00470
Title
Measurements
OG00080.20(64.66 to 95.74)
OG001103.38(89.68 to 117.08)
OG00293.82(72.51 to 115.13)
OG003
Week 24
ParticipantsOG00068
ParticipantsOG00172
ParticipantsOG00269
ParticipantsOG00366
Week 52
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0023
ParticipantsOG0032
1 affected
73 at risk
EG0040 affected73 at risk
EG0050 affected72 at risk
EG0060 affected73 at risk
1 affected
73 at risk
EG0040 affected73 at risk
EG0050 affected72 at risk
EG0060 affected73 at risk
0 affected
73 at risk
EG0041 affected73 at risk
EG0050 affected72 at risk
EG0060 affected73 at risk
0 affected
73 at risk
EG0040 affected73 at risk
EG0051 affected72 at risk
EG0060 affected73 at risk
0 affected
73 at risk
EG0040 affected73 at risk
EG0050 affected72 at risk
EG0060 affected73 at risk
0 affected
73 at risk
EG0040 affected73 at risk
EG0051 affected72 at risk
EG0060 affected73 at risk
0 affected
73 at risk
EG0040 affected73 at risk
EG0050 affected72 at risk
EG0060 affected73 at risk
0 affected
73 at risk
EG0040 affected73 at risk
EG0050 affected72 at risk
EG0061 affected73 at risk
0 affected
73 at risk
EG0040 affected73 at risk
EG0052 affected72 at risk
EG0060 affected73 at risk
0 affected
73 at risk
EG0040 affected73 at risk
EG0050 affected72 at risk
EG0060 affected73 at risk
0 affected
73 at risk
EG0040 affected73 at risk
EG0051 affected72 at risk
EG0060 affected73 at risk
0 affected
73 at risk
EG0040 affected73 at risk
EG0050 affected72 at risk
EG0060 affected73 at risk
0 affected
73 at risk
EG0040 affected73 at risk
EG0050 affected72 at risk
EG0060 affected73 at risk
1 affected
73 at risk
EG0040 affected73 at risk
EG0050 affected72 at risk
EG0060 affected73 at risk
0 affected
73 at risk
EG0041 affected73 at risk
EG0050 affected72 at risk
EG0060 affected73 at risk
0 affected
73 at risk
EG0041 affected73 at risk
EG0050 affected72 at risk
EG0060 affected73 at risk
0 affected
73 at risk
EG0041 affected73 at risk
EG0050 affected72 at risk
EG0060 affected73 at risk
1 affected
73 at risk
EG0041 affected73 at risk
EG0050 affected72 at risk
EG0060 affected73 at risk
0 affected
73 at risk
EG0040 affected73 at risk
EG0050 affected72 at risk
EG0060 affected73 at risk
0 affected
73 at risk
EG0041 affected73 at risk
EG0050 affected72 at risk
EG0060 affected73 at risk
0 affected
73 at risk
EG0040 affected73 at risk
EG0050 affected72 at risk
EG0061 affected73 at risk
0 affected
73 at risk
EG0041 affected73 at risk
EG0050 affected72 at risk
EG0060 affected73 at risk
0 affected
73 at risk
EG0040 affected73 at risk
EG0050 affected72 at risk
EG0060 affected73 at risk
0 affected
73 at risk
EG0040 affected73 at risk
EG0050 affected72 at risk
EG0060 affected73 at risk
0 affected
73 at risk
EG0040 affected73 at risk
EG0050 affected72 at risk
EG0060 affected73 at risk
0 affected
73 at risk
EG0041 affected73 at risk
EG0050 affected72 at risk
EG0060 affected73 at risk
1 affected
73 at risk
EG0040 affected73 at risk
EG0050 affected72 at risk
EG0060 affected73 at risk
0 affected
73 at risk
EG0040 affected73 at risk
EG0050 affected72 at risk
EG0060 affected73 at risk
0 affected
73 at risk
EG0040 affected73 at risk
EG0050 affected72 at risk
EG0060 affected73 at risk
0 affected
73 at risk
EG0040 affected73 at risk
EG0050 affected72 at risk
EG0060 affected73 at risk
0 affected
73 at risk
EG0041 affected73 at risk
EG0050 affected72 at risk
EG0060 affected73 at risk
0 affected
73 at risk
EG0040 affected73 at risk
EG0051 affected72 at risk
EG0060 affected73 at risk
0 affected
73 at risk
EG0040 affected73 at risk
EG0050 affected72 at risk
EG0060 affected73 at risk
0 affected
73 at risk
EG0040 affected73 at risk
EG0050 affected72 at risk
EG0061 affected73 at risk
0 affected
73 at risk
EG0040 affected73 at risk
EG0051 affected72 at risk
EG0060 affected73 at risk
0 affected
73 at risk
EG0040 affected73 at risk
EG0050 affected72 at risk
EG0060 affected73 at risk
0 affected
73 at risk
EG0040 affected73 at risk
EG0050 affected72 at risk
EG0060 affected73 at risk
0 affected
73 at risk
EG0040 affected73 at risk
EG0050 affected72 at risk
EG0060 affected73 at risk
0 affected
73 at risk
EG0040 affected73 at risk
EG0050 affected72 at risk
EG0061 affected73 at risk
0 affected
73 at risk
EG0040 affected73 at risk
EG0050 affected72 at risk
EG0061 affected73 at risk
0 affected
73 at risk
EG0041 affected73 at risk
EG0050 affected72 at risk
EG0060 affected73 at risk
0 affected
73 at risk
EG0040 affected73 at risk
EG0051 affected72 at risk
EG0060 affected73 at risk
0 affected
73 at risk
EG0040 affected73 at risk
EG0050 affected72 at risk
EG0060 affected73 at risk
0 affected
73 at risk
EG0040 affected73 at risk
EG0050 affected72 at risk
EG0060 affected73 at risk
0 affected
73 at risk
EG0040 affected73 at risk
EG0050 affected72 at risk
EG0060 affected73 at risk
0 affected
73 at risk
EG0040 affected73 at risk
EG0050 affected72 at risk
EG0060 affected73 at risk
0 affected
73 at risk
EG0040 affected73 at risk
EG0051 affected72 at risk
EG0060 affected73 at risk
0 affected
73 at risk
EG0040 affected73 at risk
EG0050 affected72 at risk
EG0060 affected73 at risk
1 affected
73 at risk
EG0040 affected73 at risk
EG0050 affected72 at risk
EG0061 affected73 at risk
0 affected
73 at risk
EG0040 affected73 at risk
EG0050 affected72 at risk
EG0060 affected73 at risk
1 affected
73 at risk
EG0040 affected73 at risk
EG0050 affected72 at risk
EG0060 affected73 at risk
0 affected
73 at risk
EG0040 affected73 at risk
EG0050 affected72 at risk
EG0060 affected73 at risk
0 affected
73 at risk
EG0040 affected73 at risk
EG0050 affected72 at risk
EG0060 affected73 at risk
0 affected
73 at risk
EG0040 affected73 at risk
EG0050 affected72 at risk
EG0060 affected73 at risk
0 affected
73 at risk
EG0040 affected73 at risk
EG0050 affected72 at risk
EG0060 affected73 at risk
0 affected
73 at risk
EG0040 affected73 at risk
EG0050 affected72 at risk
EG0060 affected73 at risk
0 affected
73 at risk
EG0040 affected73 at risk
EG0050 affected72 at risk
EG0060 affected73 at risk
1 affected
73 at risk
EG0040 affected73 at risk
EG0050 affected72 at risk
EG0060 affected73 at risk
1 affected
73 at risk
EG0040 affected73 at risk
EG0050 affected72 at risk
EG0060 affected73 at risk
0 affected
73 at risk
EG0040 affected73 at risk
EG0050 affected72 at risk
EG0060 affected73 at risk
0 affected
73 at risk
EG0040 affected73 at risk
EG0051 affected72 at risk
EG0060 affected73 at risk
1 affected
73 at risk
EG0040 affected73 at risk
EG0050 affected72 at risk
EG0060 affected73 at risk
0 affected
73 at risk
EG0040 affected73 at risk
EG0050 affected72 at risk
EG0060 affected73 at risk
0 affected
73 at risk
EG0040 affected73 at risk
EG0050 affected72 at risk
EG0060 affected73 at risk
0 affected
73 at risk
EG0040 affected73 at risk
EG0051 affected72 at risk
EG0060 affected73 at risk
0 affected
73 at risk
EG0040 affected73 at risk
EG0051 affected72 at risk
EG0060 affected73 at risk
0 affected
73 at risk
EG0040 affected73 at risk
EG0050 affected72 at risk
EG0060 affected73 at risk
1 affected
73 at risk
EG0040 affected73 at risk
EG0050 affected72 at risk
EG0060 affected73 at risk
0 affected
73 at risk
EG0040 affected73 at risk
EG0050 affected72 at risk
EG0060 affected73 at risk
0 affected
73 at risk
EG0040 affected73 at risk
EG0050 affected72 at risk
EG0060 affected73 at risk
0 affected
73 at risk
EG0040 affected73 at risk
EG0050 affected72 at risk
EG0061 affected73 at risk
0 affected
73 at risk
EG0040 affected73 at risk
EG0052 affected72 at risk
EG0060 affected73 at risk
0 affected
73 at risk
EG0040 affected73 at risk
EG0050 affected72 at risk
EG0061 affected73 at risk
0 affected
73 at risk
EG0040 affected73 at risk
EG0050 affected72 at risk
EG0060 affected73 at risk
0 affected
73 at risk
EG0040 affected73 at risk
EG0051 affected72 at risk
EG0060 affected73 at risk
0 affected
73 at risk
EG0040 affected73 at risk
EG0050 affected72 at risk
EG0060 affected73 at risk
1 affected
73 at risk
EG0040 affected73 at risk
EG0050 affected72 at risk
EG0060 affected73 at risk
0 affected
73 at risk
EG0040 affected73 at risk
EG0050 affected72 at risk
EG0060 affected73 at risk
1 affected
73 at risk
EG0040 affected73 at risk
EG0050 affected72 at risk
EG0060 affected73 at risk
0 affected
73 at risk
EG0040 affected73 at risk
EG0050 affected72 at risk
EG0061 affected73 at risk
4 affected
73 at risk
EG0046 affected73 at risk
EG0056 affected72 at risk
EG0067 affected73 at risk
6 affected
73 at risk
EG0046 affected73 at risk
EG0054 affected72 at risk
EG0063 affected73 at risk
7 affected
73 at risk
EG0046 affected73 at risk
EG0056 affected72 at risk
EG0062 affected73 at risk
4 affected
73 at risk
EG0042 affected73 at risk
EG0053 affected72 at risk
EG0063 affected73 at risk
5 affected
73 at risk
EG0045 affected73 at risk
EG0057 affected72 at risk
EG0066 affected73 at risk
2 affected
73 at risk
EG0044 affected73 at risk
EG0053 affected72 at risk
EG0064 affected73 at risk
1 affected
73 at risk
EG0046 affected73 at risk
EG0053 affected72 at risk
EG0064 affected73 at risk
2 affected
73 at risk
EG0044 affected73 at risk
EG0052 affected72 at risk
EG0061 affected73 at risk
1 affected
73 at risk
EG0044 affected73 at risk
EG0052 affected72 at risk
EG0065 affected73 at risk
2 affected
73 at risk
EG0044 affected73 at risk
EG0053 affected72 at risk
EG0063 affected73 at risk
5 affected
73 at risk
EG0042 affected73 at risk
EG0053 affected72 at risk
EG0061 affected73 at risk
3 affected
73 at risk
EG0041 affected73 at risk
EG0054 affected72 at risk
EG0065 affected73 at risk
3 affected
73 at risk
EG0042 affected73 at risk
EG0053 affected72 at risk
EG0064 affected73 at risk
2 affected
73 at risk
EG0044 affected73 at risk
EG0052 affected72 at risk
EG0064 affected73 at risk
2 affected
73 at risk
EG0044 affected73 at risk
EG0052 affected72 at risk
EG0062 affected73 at risk
3 affected
73 at risk
EG0043 affected73 at risk
EG0050 affected72 at risk
EG0063 affected73 at risk
3 affected
73 at risk
EG0042 affected73 at risk
EG0053 affected72 at risk
EG0061 affected73 at risk
2 affected
73 at risk
EG0042 affected73 at risk
EG0053 affected72 at risk
EG0060 affected73 at risk
3 affected
73 at risk
EG0043 affected73 at risk
EG0054 affected72 at risk
EG0063 affected73 at risk
2 affected
73 at risk
EG0040 affected73 at risk
EG0053 affected72 at risk
EG0064 affected73 at risk
1 affected
73 at risk
EG0043 affected73 at risk
EG0050 affected72 at risk
EG0064 affected73 at risk
2 affected
73 at risk
EG0042 affected73 at risk
EG0051 affected72 at risk
EG0060 affected73 at risk
1 affected
73 at risk
EG0043 affected73 at risk
EG0053 affected72 at risk
EG0061 affected73 at risk
2 affected
73 at risk
EG0040 affected73 at risk
EG0051 affected72 at risk
EG0062 affected73 at risk
2 affected
73 at risk
EG0041 affected73 at risk
EG0055 affected72 at risk
EG0061 affected73 at risk
0 affected
73 at risk
EG0040 affected73 at risk
EG0055 affected72 at risk
EG0063 affected73 at risk
0 affected
73 at risk
EG0044 affected73 at risk
EG0052 affected72 at risk
EG0060 affected73 at risk
0 affected
73 at risk
EG0041 affected73 at risk
EG0056 affected72 at risk
EG0060 affected73 at risk
0 affected
73 at risk
EG0041 affected73 at risk
EG0054 affected72 at risk
EG0061 affected73 at risk
1 affected
73 at risk
EG0042 affected73 at risk
EG0050 affected72 at risk
EG0064 affected73 at risk
3 affected
73 at risk
EG0040 affected73 at risk
EG0050 affected72 at risk
EG0060 affected73 at risk
1 affected
73 at risk
EG0040 affected73 at risk
EG0050 affected72 at risk
EG0062 affected73 at risk
0 affected
73 at risk
EG0040 affected73 at risk
EG0051 affected72 at risk
EG0061 affected73 at risk
1 affected
73 at risk
EG0044 affected73 at risk
EG0050 affected72 at risk
EG0060 affected73 at risk
62.50
± 3.263
OG00464.42± 3.263
OG00558.19± 3.286
57
OG00458
OG00557
OG00662
within 10 letters
OG00011
OG00115
OG00212
OG00313
OG00412
OG00511
OG0068
within 15 letters
OG0006
OG0015
OG0025
OG0031
OG0043
OG0052
OG0063
more than 15 letters
OG0005
OG0012
OG0020
OG0031
OG0040
OG0051
OG0060
ParticipantsOG00473
ParticipantsOG00571
ParticipantsOG00673
Title
Measurements
within 5 letters
OG00053
OG00157
OG00265
OG00359
OG00461
OG00560
OG00660
within 10 letters
OG00016
OG00112
OG0026
OG00312
OG004
within 15 letters
OG0002
OG0012
OG0022
OG0031
OG004
more than 15 letters
OG0001
OG0010
OG0020
OG0030
OG004
ParticipantsOG00471
ParticipantsOG00571
ParticipantsOG00672
Title
Measurements
within 5 letters
OG00034
OG00136
OG00251
OG00351
OG00444
OG00547
OG00654
within 10 letters
OG00021
OG00123
OG00218
OG00318
OG004
within 15 letters
OG00011
OG0017
OG0025
OG0031
OG004
more than 15 letters
OG0005
OG0014
OG0020
OG0033
OG004
ParticipantsOG00471
ParticipantsOG00571
ParticipantsOG00672
Title
Measurements
within 5 letters
OG00042
OG00148
OG00260
OG00352
OG00452
OG00555
OG00651
within 10 letters
OG00019
OG00117
OG00210
OG00320
OG004
within 15 letters
OG0009
OG0015
OG0022
OG0031
OG004
more than 15 letters
OG0002
OG0010
OG0021
OG0030
OG004
ParticipantsOG00472
ParticipantsOG00569
ParticipantsOG00670
Title
Measurements
within 5 letters
OG00026
OG00125
OG00248
OG00341
OG00435
OG00534
OG00646
within 10 letters
OG00027
OG00130
OG00217
OG00323
OG004
within 15 letters
OG00013
OG0018
OG0028
OG0034
OG004
more than 15 letters
OG0005
OG0015
OG0021
OG0034
OG004
ParticipantsOG00472
ParticipantsOG00569
ParticipantsOG00670
Title
Measurements
within 5 letters
OG00036
OG00141
OG00252
OG00346
OG00447
OG00549
OG00645
within 10 letters
OG00023
OG00118
OG00218
OG00320
OG004
within 15 letters
OG0009
OG0018
OG0022
OG0034
OG004
more than 15 letters
OG0004
OG0011
OG0021
OG0031
OG004
ParticipantsOG00471
ParticipantsOG00569
ParticipantsOG00668
Title
Measurements
within 5 letters
OG00024
OG00120
OG00241
OG00336
OG00426
OG00526
OG00635
within 10 letters
OG00028
OG00137
OG00222
OG00325
OG004
within 15 letters
OG00010
OG0014
OG0029
OG0034
OG004
more than 15 letters
OG0009
OG0017
OG0021
OG0035
OG004
ParticipantsOG00471
ParticipantsOG00569
ParticipantsOG00668
Title
Measurements
within 5 letters
OG00035
OG00132
OG00247
OG00340
OG00442
OG00543
OG00639
within 10 letters
OG00024
OG00124
OG00221
OG00325
OG004
within 15 letters
OG0009
OG0018
OG0023
OG0034
OG004
more than 15 letters
OG0004
OG0014
OG0021
OG0031
OG004
ParticipantsOG00471
ParticipantsOG00569
ParticipantsOG00667
Title
Measurements
within 5 letters
OG00021
OG00119
OG00232
OG00332
OG00426
OG00521
OG00630
within 10 letters
OG00032
OG00136
OG00225
OG00326
OG004
within 15 letters
OG00010
OG0015
OG00212
OG0038
OG004
more than 15 letters
OG0006
OG0018
OG0022
OG0034
OG004
ParticipantsOG00471
ParticipantsOG00569
ParticipantsOG00667
Title
Measurements
within 5 letters
OG00028
OG00128
OG00241
OG00334
OG00432
OG00540
OG00635
within 10 letters
OG00028
OG00127
OG00225
OG00328
OG004
within 15 letters
OG00010
OG0019
OG0023
OG0034
OG004
more than 15 letters
OG0004
OG0014
OG0021
OG0033
OG004
ParticipantsOG00471
ParticipantsOG00569
ParticipantsOG00666
Title
Measurements
within 5 letters
OG00019
OG00116
OG00228
OG00326
OG00423
OG00520
OG00625
within 10 letters
OG00029
OG00136
OG00230
OG00331
OG004
within 15 letters
OG00014
OG0018
OG00212
OG0039
OG004
more than 15 letters
OG0007
OG0018
OG0022
OG0033
OG004
ParticipantsOG00471
ParticipantsOG00569
ParticipantsOG00666
Title
Measurements
within 5 letters
OG00027
OG00124
OG00236
OG00332
OG00432
OG00536
OG00633
within 10 letters
OG00030
OG00129
OG00229
OG00325
OG004
within 15 letters
OG0008
OG00111
OG0025
OG0039
OG004
more than 15 letters
OG0005
OG0014
OG0021
OG0033
OG004
ParticipantsOG00470
ParticipantsOG00568
ParticipantsOG00666
Title
Measurements
within 5 letters
OG00019
OG00113
OG00226
OG00324
OG00422
OG00517
OG00618
within 10 letters
OG00030
OG00137
OG00229
OG00333
OG004
within 15 letters
OG00014
OG0019
OG00214
OG0039
OG004
more than 15 letters
OG0005
OG0019
OG0022
OG0033
OG004
ParticipantsOG00470
ParticipantsOG00568
ParticipantsOG00666
Title
Measurements
within 5 letters
OG00026
OG00124
OG00234
OG00327
OG00429
OG00534
OG00631
within 10 letters
OG00029
OG00130
OG00227
OG00327
OG004
within 15 letters
OG0007
OG00110
OG0027
OG0039
OG004
more than 15 letters
OG0007
OG0014
OG0022
OG0035
OG004
ParticipantsOG00468
ParticipantsOG00566
ParticipantsOG00663
Title
Measurements
within 5 letters
OG00017
OG00111
OG00223
OG00323
OG00420
OG00514
OG00612
within 10 letters
OG00032
OG00137
OG00233
OG00332
OG004
within 15 letters
OG00014
OG00111
OG00211
OG00310
OG004
more than 15 letters
OG0004
OG0019
OG0023
OG0034
OG004
ParticipantsOG00468
ParticipantsOG00566
ParticipantsOG00663
Title
Measurements
within 5 letters
OG00023
OG00123
OG00230
OG00324
OG00427
OG00530
OG00624
within 10 letters
OG00031
OG00131
OG00231
OG00330
OG004
within 15 letters
OG0008
OG00110
OG0025
OG0038
OG004
more than 15 letters
OG0006
OG0014
OG0023
OG0037
OG004
ParticipantsOG00469
ParticipantsOG00567
ParticipantsOG00663
Title
Measurements
within 5 letters
OG00016
OG00110
OG00222
OG00320
OG00419
OG00513
OG00612
within 10 letters
OG00031
OG00136
OG00234
OG00334
OG004
within 15 letters
OG00014
OG00111
OG00213
OG0037
OG004
more than 15 letters
OG0004
OG0019
OG0022
OG0037
OG004
ParticipantsOG00469
ParticipantsOG00567
ParticipantsOG00663
Title
Measurements
within 5 letters
OG00022
OG00119
OG00229
OG00321
OG00425
OG00526
OG00621
within 10 letters
OG00031
OG00131
OG00232
OG00334
OG004
within 15 letters
OG0006
OG00112
OG0026
OG0038
OG004
more than 15 letters
OG0008
OG0014
OG0023
OG0035
OG004
ParticipantsOG00468
ParticipantsOG00567
ParticipantsOG00662
Title
Measurements
within 5 letters
OG00014
OG00111
OG00219
OG00320
OG00418
OG00513
OG00612
within 10 letters
OG00033
OG00132
OG00235
OG00334
OG004
within 15 letters
OG00012
OG00116
OG00214
OG0037
OG004
more than 15 letters
OG0008
OG0019
OG0022
OG0037
OG004
ParticipantsOG00467
ParticipantsOG00567
ParticipantsOG00663
Title
Measurements
within 5 letters
OG00020
OG00116
OG00223
OG00321
OG00423
OG00525
OG00621
within 10 letters
OG00031
OG00136
OG00237
OG00335
OG004
within 15 letters
OG0009
OG00113
OG0026
OG0037
OG004
more than 15 letters
OG0008
OG0013
OG0023
OG0035
OG004
ParticipantsOG00467
ParticipantsOG00565
ParticipantsOG00662
Title
Measurements
within 5 letters
OG00011
OG00110
OG00218
OG00317
OG00417
OG00513
OG00611
within 10 letters
OG00036
OG00133
OG00235
OG00332
OG004
within 15 letters
OG00010
OG00116
OG00214
OG00312
OG004
more than 15 letters
OG0009
OG0019
OG0023
OG0036
OG004
ParticipantsOG00467
ParticipantsOG00565
ParticipantsOG00663
Title
Measurements
within 5 letters
OG00015
OG00116
OG00222
OG00320
OG00421
OG00525
OG00619
within 10 letters
OG00035
OG00136
OG00236
OG00332
OG004
within 15 letters
OG0008
OG00112
OG0027
OG0039
OG004
more than 15 letters
OG0009
OG0014
OG0024
OG0036
OG004
ParticipantsOG00468
ParticipantsOG00566
ParticipantsOG00662
Title
Measurements
within 5 letters
OG00010
OG0019
OG00214
OG00316
OG00415
OG00513
OG00611
within 10 letters
OG00036
OG00132
OG00237
OG00331
OG004
within 15 letters
OG0009
OG00118
OG00216
OG00313
OG004
more than 15 letters
OG0009
OG0018
OG0024
OG0037
OG004
ParticipantsOG00468
ParticipantsOG00566
ParticipantsOG00662
Title
Measurements
within 5 letters
OG00014
OG00114
OG00220
OG00318
OG00421
OG00524
OG00617
within 10 letters
OG00035
OG00136
OG00240
OG00333
OG004
within 15 letters
OG0008
OG00112
OG0025
OG0038
OG004
more than 15 letters
OG0008
OG0015
OG0025
OG0037
OG004
ParticipantsOG00467
ParticipantsOG00564
ParticipantsOG00662
Title
Measurements
within 5 letters
OG00011
OG0018
OG00212
OG00315
OG00413
OG00513
OG00610
within 10 letters
OG00032
OG00131
OG00238
OG00331
OG004
within 15 letters
OG00011
OG00119
OG00215
OG00314
OG004
more than 15 letters
OG00010
OG0018
OG0026
OG0037
OG004
ParticipantsOG00467
ParticipantsOG00564
ParticipantsOG00661
Title
Measurements
within 5 letters
OG00013
OG00114
OG00220
OG00319
OG00418
OG00521
OG00616
within 10 letters
OG00035
OG00135
OG00239
OG00331
OG004
within 15 letters
OG0008
OG00111
OG0025
OG0039
OG004
more than 15 letters
OG0008
OG0016
OG0026
OG0038
OG004
-27.6
± 136.79
OG00416.6± 75.36
OG0059.7± 76.41
OG006-10.4± 79.28
ParticipantsOG00431
ParticipantsOG00534
ParticipantsOG00632
Title
Measurements
OG0009.6± 77.04
OG00111.1± 62.94
OG0029.4± 84.10
OG003-8.9± 54.05
OG004-8.4± 87.97
OG0054.2± 72.25
OG006-18.1± 101.47
ParticipantsOG00416
ParticipantsOG00521
ParticipantsOG00621
Title
Measurements
OG00012.7± 76.07
OG0016.9± 63.99
OG0023.6± 95.68
OG003-37.3± 118.33
OG00431.4± 56.63
OG0057.4± 93.46
OG006-40.8± 72.12
ParticipantsOG00430
ParticipantsOG00532
ParticipantsOG00631
Title
Measurements
OG000-2.9± 48.00
OG0015.5± 73.67
OG002-10.5± 65.41
OG003-9.7± 61.55
OG004-12.3± 101.63
OG005-7.2± 89.75
OG006-14.2± 108.24
ParticipantsOG00411
ParticipantsOG00512
ParticipantsOG00612
Title
Measurements
OG00020.9± 104.87
OG00130.8± 75.58
OG002-15.9± 64.65
OG003-44.4± 114.54
OG00427.8± 113.06
OG005-28.5± 101.42
OG006-16.6± 89.64
ParticipantsOG00459
ParticipantsOG00556
ParticipantsOG00652
Title
Measurements
OG0009.9± 72.13
OG00111.0± 53.06
OG0028.5± 65.28
OG003-8.6± 92.03
OG004-7.7± 66.09
OG00514.1± 65.43
OG006-15.0± 87.50
ParticipantsOG00410
ParticipantsOG00512
ParticipantsOG00611
Title
Measurements
OG000-24.1± 66.83
OG00113.8± 120.91
OG002-57.8± 85.39
OG003-50.3± 63.87
OG004-8.2± 56.80
OG005-9.0± 142.59
OG006-29.0± 91.44
ParticipantsOG00457
ParticipantsOG00552
ParticipantsOG00652
Title
Measurements
OG0000.1± 64.33
OG0019.6± 61.19
OG0022.2± 74.83
OG003-13.7± 97.67
OG0043.2± 86.08
OG005-3.0± 67.15
OG006-23.5± 90.13
48
OG00445
OG00544
Participants
OG004
59
ParticipantsOG00557
Title
Measurements
OG00045
OG00140
OG00249
OG00347
OG00446
OG00542
Participants
OG004
0
ParticipantsOG0050
Title
Measurements
OG0001
OG0010
OG0020
OG0030
OG0040
OG0050
Participants
OG004
73
ParticipantsOG00572
Title
Measurements
OG0000
OG0010
OG0020
OG0031
OG0040
OG0050
Participants
OG004
56
ParticipantsOG00550
Title
Measurements
OG00038
OG00141
OG00245
OG00347
OG00439
OG00536
Participants
OG004
73
ParticipantsOG0051
Title
Measurements
OG0000
OG0010
OG0020
OG0031
OG0040
OG0051
Participants
OG004
73
ParticipantsOG00572
Title
Measurements
OG0000
OG0011
OG0020
OG0030
OG0040
OG0050
Participants
OG004
52
ParticipantsOG00554
Title
Measurements
OG00036
OG00128
OG00243
OG00337
OG00445
OG00536
-0.16
± 0.134
OG004-0.10± 0.132
OG0050.13± 0.134
OG006-0.08± 0.137
0.01
± 0.151
OG004-0.05± 0.150
OG0050.20± 0.152
OG006-0.11± 0.155
-0.77
± 0.177
OG004-0.57± 0.175
OG005-0.37± 0.178
OG006-0.66± 0.181
-1.24
± 0.312
OG004-1.17± 0.321
OG005-0.83± 0.321
OG006-1.02± 0.322
44
OG00446
OG00541
OG00642
2
OG0043
OG0052
OG0063
1
OG0040
OG0050
OG0061
0
OG0040
OG0051
OG0060
0
OG0040
OG0051
OG0060
1
OG0042
OG0050
OG0062
0
OG0048
OG0052
OG0062
1
OG0049
OG0052
OG0063
0
OG0042
OG0050
OG0060
0
OG0042
OG0050
OG0060
0
OG0041
OG0055
OG0060
1
OG0041
OG0053
OG0061
0
OG0041
OG0051
OG0060
0
OG0041
OG0051
OG0060
0
OG0042
OG0054
OG0060
0
OG0041
OG0050
OG0062
0
OG0040
OG0050
OG0060
0
OG0040
OG0050
OG0060
0
OG0041
OG0050
OG0060
0
OG0042
OG0050
OG0060
0
OG0040
OG0050
OG0060
1
OG0040
OG0050
OG0060
1
OG0041
OG0050
OG0061
1
OG0040
OG0050
OG0061
0
OG0040
OG0050
OG0060
2
OG0040
OG0050
OG0060
0
OG0040
OG0050
OG0060
1
OG0040
OG0050
OG0060
6
OG0045
OG0057
OG0066
4
OG0044
OG0054
OG0066
9
OG0049
OG00516
OG0065
10
OG0045
OG0055
OG0066
6
OG0044
OG0053
OG0066
0
OG0040
OG0050
OG0060
1
OG0040
OG0050
OG0062
5
OG0041
OG0052
OG0064
0
OG0040
OG0050
OG0060
0
OG0041
OG0050
OG0060
ParticipantsOG00473
ParticipantsOG00571
ParticipantsOG00673
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0061
ParticipantsOG00472
ParticipantsOG00571
ParticipantsOG00672
Title
Measurements
OG0001
OG0010
OG0020
OG0030
OG0041
OG0051
OG0060
73
ParticipantsOG00472
ParticipantsOG00571
ParticipantsOG00669
Title
Measurements
OG0001
OG0010
OG0021
OG0030
OG0040
OG0052
OG0061
70
ParticipantsOG00471
ParticipantsOG00569
ParticipantsOG00668
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0041
OG0050
OG0060
70
ParticipantsOG00471
ParticipantsOG00569
ParticipantsOG00667
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0041
OG0050
OG0060
69
ParticipantsOG00471
ParticipantsOG00569
ParticipantsOG00666
Title
Measurements
OG0000
OG0010
OG0021
OG0030
OG0041
OG0051
OG0060
ParticipantsOG00471
ParticipantsOG00569
ParticipantsOG00666
Title
Measurements
OG0000
OG0010
OG0020
OG0031
OG0040
OG0050
OG0060
ParticipantsOG00470
ParticipantsOG00568
ParticipantsOG00666
Title
Measurements
OG0000
OG0010
OG0020
OG0031
OG0040
OG0050
OG0060
69
ParticipantsOG00468
ParticipantsOG00567
ParticipantsOG00662
Title
Measurements
OG0001
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
68
ParticipantsOG00469
ParticipantsOG00567
ParticipantsOG00664
Title
Measurements
OG0000
OG0010
OG0020
OG0032
OG0040
OG0050
OG0061
67
ParticipantsOG00467
ParticipantsOG00565
ParticipantsOG00663
Title
Measurements
OG0001
OG0010
OG0020
OG0030
OG0040
OG0050
OG0061
66
ParticipantsOG00468
ParticipantsOG00566
ParticipantsOG00662
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0051
OG0060
67
ParticipantsOG00467
ParticipantsOG00564
ParticipantsOG00662
Title
Measurements
OG0000
OG0010
OG0021
OG0030
OG0040
OG0050
OG0060
ParticipantsOG00473
ParticipantsOG00572
ParticipantsOG00673
Title
Measurements
OG0000
OG0011
OG0020
OG0030
OG0040
OG0050
OG0062
ParticipantsOG00473
ParticipantsOG00571
ParticipantsOG00673
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0041
OG0051
OG0060
ParticipantsOG00472
ParticipantsOG00571
ParticipantsOG00672
Title
Measurements
OG0000
OG0011
OG0020
OG0031
OG0040
OG0051
OG0061
72
ParticipantsOG00472
ParticipantsOG00569
ParticipantsOG00669
Title
Measurements
OG0000
OG0010
OG0020
OG0032
OG0041
OG0055
OG0062
70
ParticipantsOG00471
ParticipantsOG00569
ParticipantsOG00668
Title
Measurements
OG0000
OG0011
OG0020
OG0031
OG0042
OG0051
OG0062
70
ParticipantsOG00471
ParticipantsOG00569
ParticipantsOG00667
Title
Measurements
OG0001
OG0010
OG0023
OG0030
OG0043
OG0051
OG0061
69
ParticipantsOG00471
ParticipantsOG00569
ParticipantsOG00666
Title
Measurements
OG0000
OG0010
OG0023
OG0031
OG0043
OG0051
OG0062
69
ParticipantsOG00470
ParticipantsOG00568
ParticipantsOG00666
Title
Measurements
OG0001
OG0010
OG0020
OG0035
OG0041
OG0053
OG0065
69
ParticipantsOG00468
ParticipantsOG00567
ParticipantsOG00662
Title
Measurements
OG0000
OG0010
OG0022
OG0030
OG0041
OG0052
OG0060
68
ParticipantsOG00469
ParticipantsOG00567
ParticipantsOG00664
Title
Measurements
OG0001
OG0010
OG0022
OG0032
OG0040
OG0052
OG0061
68
ParticipantsOG00467
ParticipantsOG00567
ParticipantsOG00663
Title
Measurements
OG0001
OG0010
OG0022
OG0031
OG0040
OG0051
OG0061
73
ParticipantsOG00473
ParticipantsOG00572
ParticipantsOG00673
Title
Measurements
OG0002
OG0010
OG0020
OG0031
OG0042
OG0050
OG0060
ParticipantsOG00473
ParticipantsOG00572
ParticipantsOG00673
Title
Measurements
OG0001
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
73
ParticipantsOG00473
ParticipantsOG00572
ParticipantsOG00673
Title
Measurements
OG0001
OG0010
OG0020
OG0030
OG0040
OG0051
OG0062
73
ParticipantsOG00473
ParticipantsOG00572
ParticipantsOG00673
Title
Measurements
OG0002
OG0012
OG0022
OG0031
OG0042
OG0052
OG0062
ParticipantsOG00471
ParticipantsOG00569
ParticipantsOG00668
Title
Measurements
OG0000
OG0011
OG0020
OG0030
OG0040
OG0050
OG0060
ParticipantsOG00471
ParticipantsOG00569
ParticipantsOG00667
Title
Measurements
OG0000
OG0011
OG0020
OG0031
OG0040
OG0051
OG0060
ParticipantsOG00471
ParticipantsOG00569
ParticipantsOG00666
Title
Measurements
OG0000
OG0011
OG0020
OG0030
OG0040
OG0050
OG0060
ParticipantsOG00468
ParticipantsOG00566
ParticipantsOG00662
Title
Measurements
OG0000
OG0010
OG0020
OG0031
OG0040
OG0050
OG0060
ParticipantsOG00469
ParticipantsOG00567
ParticipantsOG00664
Title
Measurements
OG0001
OG0011
OG0020
OG0030
OG0040
OG0050
OG0060
ParticipantsOG00467
ParticipantsOG00567
ParticipantsOG00663
Title
Measurements
OG0000
OG0011
OG0020
OG0030
OG0040
OG0050
OG0060
ParticipantsOG00466
ParticipantsOG00568
ParticipantsOG00662
Title
Measurements
OG0000
OG0011
OG0020
OG0030
OG0040
OG0050
OG0060
10
OG00413
OG00517
OG00615
ParticipantsOG00472
ParticipantsOG00572
ParticipantsOG00671
Title
Measurements
OG00024
OG00125
OG00225
OG00325
OG00424
OG00531
OG00627
ParticipantsOG00446
ParticipantsOG00549
ParticipantsOG00649
Title
Measurements
OG00010
OG0018
OG0029
OG00310
OG0047
OG0057
OG00616
ParticipantsOG00446
ParticipantsOG00549
ParticipantsOG00649
Title
Measurements
OG00021
OG00122
OG00217
OG00322
OG00418
OG00525
OG00618
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG0061
Title
Measurements
OG0010
OG0061
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG0061
Title
Measurements
OG0011
OG0060
ParticipantsOG00460
ParticipantsOG00552
ParticipantsOG00653
Title
Measurements
OG00011
OG0015
OG00211
OG00310
OG0048
OG0059
OG00610
ParticipantsOG00460
ParticipantsOG00552
ParticipantsOG00653
Title
Measurements
OG00023
OG00129
OG00225
OG00321
OG00424
OG00522
OG00620
0
OG0040
OG0050
OG0060
ParticipantsOG00468
ParticipantsOG00567
ParticipantsOG00669
Title
Measurements
OG0000
OG0010
OG0020
OG0031
OG0040
OG0050
OG0060
ParticipantsOG00470
ParticipantsOG00567
ParticipantsOG00665
Title
Measurements
OG0000
OG0010
OG0020
OG0031
OG0040
OG0050
OG0060
ParticipantsOG00465
ParticipantsOG00563
ParticipantsOG00661
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0061
ParticipantsOG00472
ParticipantsOG00570
ParticipantsOG00673
Title
Measurements
OG0001
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
ParticipantsOG00470
ParticipantsOG00567
ParticipantsOG00665
Title
Measurements
OG0001
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
ParticipantsOG00470
ParticipantsOG00567
ParticipantsOG00665
Title
Measurements
OG0001
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
ParticipantsOG00470
ParticipantsOG00569
ParticipantsOG00664
Title
Measurements
OG0001
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
ParticipantsOG00466
ParticipantsOG00565
ParticipantsOG00662
Title
Measurements
OG0001
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
ParticipantsOG00469
ParticipantsOG00567
ParticipantsOG00669
Title
Measurements
OG0000
OG0010
OG0020
OG0031
OG0040
OG0050
OG0060
ParticipantsOG00470
ParticipantsOG00566
ParticipantsOG00665
Title
Measurements
OG0000
OG0010
OG0020
OG0031
OG0040
OG0050
OG0060
ParticipantsOG00470
ParticipantsOG00568
ParticipantsOG00666
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0051
OG0060
ParticipantsOG00470
ParticipantsOG00569
ParticipantsOG00664
Title
Measurements
OG0000
OG0011
OG0020
OG0030
OG0040
OG0050
OG0061
ParticipantsOG00464
ParticipantsOG00563
ParticipantsOG00662
Title
Measurements
OG0000
OG0011
OG0020
OG0030
OG0040
OG0050
OG0060
ParticipantsOG00463
ParticipantsOG00570
ParticipantsOG00671
Title
Measurements
OG0002
OG0011
OG0020
OG0030
OG0040
OG0050
OG0060
ParticipantsOG00472
ParticipantsOG00570
ParticipantsOG00673
Title
Measurements
OG0001
OG0010
OG0020
OG0031
OG0041
OG0050
OG0060
ParticipantsOG00469
ParticipantsOG00566
ParticipantsOG00665
Title
Measurements
OG0002
OG0010
OG0020
OG0030
OG0041
OG0050
OG0060
ParticipantsOG00468
ParticipantsOG00565
ParticipantsOG00663
Title
Measurements
OG0001
OG0010
OG0020
OG0030
OG0041
OG0050
OG0060
ParticipantsOG00465
ParticipantsOG00563
ParticipantsOG00661
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0051
OG0060
ParticipantsOG00469
ParticipantsOG00570
ParticipantsOG00671
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0051
OG0060
ParticipantsOG00471
ParticipantsOG00570
ParticipantsOG00673
Title
Measurements
OG0001
OG0010
OG0021
OG0030
OG0041
OG0052
OG0062
ParticipantsOG0040
ParticipantsOG0051
ParticipantsOG0062
Title
Measurements
OG0000
OG0011
OG0020
OG0031
OG0040
OG0050
OG0060
ParticipantsOG00469
ParticipantsOG00566
ParticipantsOG00665
Title
Measurements
OG0000
OG0011
OG0021
OG0031
OG0042
OG0051
OG0061
ParticipantsOG00468
ParticipantsOG00565
ParticipantsOG00663
Title
Measurements
OG0003
OG0011
OG0020
OG0030
OG0040
OG0054
OG0061
ParticipantsOG0040
ParticipantsOG0052
ParticipantsOG0061
Title
Measurements
OG0001
OG0011
OG0020
OG0030
OG0040
OG0050
OG0060
ParticipantsOG00468
ParticipantsOG00565
ParticipantsOG00662
Title
Measurements
OG0000
OG0011
OG0021
OG0031
OG0040
OG0051
OG0061
ParticipantsOG00465
ParticipantsOG00563
ParticipantsOG00661
Title
Measurements
OG0001
OG0013
OG0021
OG0032
OG0041
OG0052
OG0062
ParticipantsOG00469
ParticipantsOG00570
ParticipantsOG00672
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0051
OG0060
ParticipantsOG00472
ParticipantsOG00570
ParticipantsOG00673
Title
Measurements
OG0001
OG0010
OG0020
OG0030
OG0040
OG0051
OG0060
ParticipantsOG00470
ParticipantsOG00567
ParticipantsOG00665
Title
Measurements
OG0000
OG0010
OG0020
OG0031
OG0041
OG0051
OG0060
ParticipantsOG00468
ParticipantsOG00565
ParticipantsOG00663
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0062
ParticipantsOG00466
ParticipantsOG00563
ParticipantsOG00661
Title
Measurements
OG0000
OG0011
OG0020
OG0031
OG0040
OG0051
OG0060
ParticipantsOG00469
ParticipantsOG00570
ParticipantsOG00672
Title
Measurements
OG0006
OG0015
OG0023
OG0033
OG0041
OG0053
OG0067
ParticipantsOG00469
ParticipantsOG00570
ParticipantsOG00672
Title
Measurements
OG0000
OG0010
OG0021
OG0030
OG0040
OG0051
OG0060
ParticipantsOG00472
ParticipantsOG00570
ParticipantsOG00673
Title
Measurements
OG0002
OG0013
OG0023
OG0034
OG0042
OG0052
OG0063
ParticipantsOG00472
ParticipantsOG00570
ParticipantsOG00673
Title
Measurements
OG0000
OG0011
OG0022
OG0030
OG0040
OG0051
OG0062
ParticipantsOG0040
ParticipantsOG0051
ParticipantsOG0062
Title
Measurements
OG0000
OG0010
OG0020
OG0031
OG0040
OG0050
OG0060
ParticipantsOG00470
ParticipantsOG00567
ParticipantsOG00665
Title
Measurements
OG0003
OG0015
OG0023
OG0032
OG0044
OG0052
OG0068
ParticipantsOG00470
ParticipantsOG00567
ParticipantsOG00665
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0061
ParticipantsOG00468
ParticipantsOG00565
ParticipantsOG00663
Title
Measurements
OG0003
OG0014
OG0023
OG0034
OG0041
OG0050
OG0066
ParticipantsOG00468
ParticipantsOG00565
ParticipantsOG00663
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0041
OG0050
OG0060
ParticipantsOG0041
ParticipantsOG0052
ParticipantsOG0061
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0051
OG0060
ParticipantsOG0042
ParticipantsOG0050
ParticipantsOG0060
Title
Measurements
OG0010
OG0041
ParticipantsOG00468
ParticipantsOG00565
ParticipantsOG00662
Title
Measurements
OG0006
OG0017
OG0024
OG0035
OG0041
OG0053
OG0069
ParticipantsOG00468
ParticipantsOG00565
ParticipantsOG00662
Title
Measurements
OG0000
OG0011
OG0020
OG0030
OG0040
OG0050
OG0060
ParticipantsOG00466
ParticipantsOG00563
ParticipantsOG00661
Title
Measurements
OG0006
OG0013
OG0027
OG0035
OG0044
OG0053
OG0065
ParticipantsOG0040
ParticipantsOG0052
ParticipantsOG0062
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0061
ParticipantsOG00470
ParticipantsOG00570
ParticipantsOG00672
Title
Measurements
OG0001
OG0013
OG0023
OG0033
OG0043
OG0050
OG0061
ParticipantsOG00472
ParticipantsOG00569
ParticipantsOG00669
Title
Measurements
OG0000
OG0011
OG0022
OG0033
OG0041
OG0051
OG0061
ParticipantsOG00471
ParticipantsOG00568
ParticipantsOG00666
Title
Measurements
OG0002
OG0010
OG0022
OG0032
OG0042
OG0052
OG0061
ParticipantsOG00467
ParticipantsOG00568
ParticipantsOG00665
Title
Measurements
OG0001
OG0010
OG0022
OG0032
OG0042
OG0050
OG0062
ParticipantsOG00468
ParticipantsOG00563
ParticipantsOG00662
Title
Measurements
OG0002
OG0011
OG0023
OG0034
OG0040
OG0051
OG0060
ParticipantsOG00466
ParticipantsOG00563
ParticipantsOG00660
Title
Measurements
OG0001
OG0011
OG0021
OG0032
OG0042
OG0053
OG0061
ParticipantsOG00470
ParticipantsOG00571
ParticipantsOG00670
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0051
OG0060
ParticipantsOG00470
ParticipantsOG00571
ParticipantsOG00670
Title
Measurements
OG0000
OG0010
OG0021
OG0030
OG0041
OG0050
OG0060
ParticipantsOG00472
ParticipantsOG00567
ParticipantsOG00671
Title
Measurements
OG0001
OG0010
OG0020
OG0030
OG0040
OG0051
OG0060
ParticipantsOG00472
ParticipantsOG00567
ParticipantsOG00671
Title
Measurements
OG0001
OG0010
OG0022
OG0030
OG0040
OG0050
OG0060
ParticipantsOG00471
ParticipantsOG00568
ParticipantsOG00666
Title
Measurements
OG0001
OG0010
OG0020
OG0031
OG0040
OG0052
OG0060
ParticipantsOG00471
ParticipantsOG00568
ParticipantsOG00666
Title
Measurements
OG0000
OG0010
OG0020
OG0031
OG0040
OG0050
OG0060
ParticipantsOG00467
ParticipantsOG00568
ParticipantsOG00665
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0051
OG0060
ParticipantsOG00467
ParticipantsOG00568
ParticipantsOG00665
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0061
ParticipantsOG00468
ParticipantsOG00564
ParticipantsOG00662
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0041
OG0051
OG0060
ParticipantsOG0040
ParticipantsOG0051
ParticipantsOG0061
Title
Measurements
OG0000
OG0010
OG0051
OG0060
ParticipantsOG00466
ParticipantsOG00562
ParticipantsOG00660
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0051
OG0060
ParticipantsOG00469
ParticipantsOG00570
ParticipantsOG00671
Title
Measurements
OG0001
OG0013
OG0021
OG0030
OG0040
OG0050
OG0060
ParticipantsOG00469
ParticipantsOG00570
ParticipantsOG00671
Title
Measurements
OG0000
OG0010
OG0020
OG0031
OG0040
OG0050
OG0061
ParticipantsOG00471
ParticipantsOG00570
ParticipantsOG00673
Title
Measurements
OG0000
OG0011
OG0020
OG0031
OG0040
OG0050
OG0062
ParticipantsOG00471
ParticipantsOG00570
ParticipantsOG00673
Title
Measurements
OG0000
OG0010
OG0020
OG0031
OG0040
OG0050
OG0060
ParticipantsOG00469
ParticipantsOG00566
ParticipantsOG00664
Title
Measurements
OG0003
OG0010
OG0021
OG0030
OG0040
OG0050
OG0061
ParticipantsOG00469
ParticipantsOG00566
ParticipantsOG00664
Title
Measurements
OG0000
OG0010
OG0020
OG0031
OG0040
OG0050
OG0060
ParticipantsOG00468
ParticipantsOG00565
ParticipantsOG00663
Title
Measurements
OG0001
OG0011
OG0020
OG0030
OG0040
OG0050
OG0061
ParticipantsOG00468
ParticipantsOG00565
ParticipantsOG00662
Title
Measurements
OG0000
OG0011
OG0020
OG0032
OG0040
OG0051
OG0060
ParticipantsOG00465
ParticipantsOG00563
ParticipantsOG00661
Title
Measurements
OG0001
OG0010
OG0021
OG0030
OG0042
OG0051
OG0060
ParticipantsOG00470
ParticipantsOG00567
ParticipantsOG00665
Title
Measurements
OG0001
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
ParticipantsOG00468
ParticipantsOG00565
ParticipantsOG00662
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0041
OG0050
OG0060
ParticipantsOG00466
ParticipantsOG00563
ParticipantsOG00661
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0062
ParticipantsOG00459
ParticipantsOG00564
ParticipantsOG00661
Title
Measurements
OG0002
OG0012
OG0023
OG0033
OG0042
OG0051
OG0061
ParticipantsOG00459
ParticipantsOG00564
ParticipantsOG00661
Title
Measurements
OG0001
OG0011
OG0022
OG0031
OG0041
OG0053
OG0060
ParticipantsOG00459
ParticipantsOG00559
ParticipantsOG00658
Title
Measurements
OG0000
OG0012
OG0022
OG0034
OG0042
OG0052
OG0061
ParticipantsOG00460
ParticipantsOG00560
ParticipantsOG00661
Title
Measurements
OG0001
OG0012
OG0023
OG0035
OG0043
OG0052
OG0062
ParticipantsOG00458
ParticipantsOG00555
ParticipantsOG00656
Title
Measurements
OG0003
OG0012
OG0021
OG0034
OG0042
OG0053
OG0064
ParticipantsOG00466
ParticipantsOG00565
ParticipantsOG00662
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0051
OG0060
ParticipantsOG00466
ParticipantsOG00565
ParticipantsOG00661
Title
Measurements
OG0001
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
ParticipantsOG00465
ParticipantsOG00561
ParticipantsOG00660
Title
Measurements
OG0001
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
ParticipantsOG00470
ParticipantsOG00570
ParticipantsOG00672
Title
Measurements
OG0000
OG0011
OG0022
OG0030
OG0041
OG0050
OG0062
ParticipantsOG00472
ParticipantsOG00569
ParticipantsOG00669
Title
Measurements
OG0000
OG0011
OG0021
OG0030
OG0040
OG0051
OG0061
ParticipantsOG00471
ParticipantsOG00568
ParticipantsOG00666
Title
Measurements
OG0001
OG0012
OG0020
OG0030
OG0040
OG0050
OG0060
ParticipantsOG0042
ParticipantsOG0052
ParticipantsOG0061
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0051
OG0060
ParticipantsOG00468
ParticipantsOG00563
ParticipantsOG00662
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0041
OG0050
OG0060
ParticipantsOG00466
ParticipantsOG00563
ParticipantsOG00660
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0041
OG0050
OG0060
ParticipantsOG00469
ParticipantsOG00570
ParticipantsOG00672
Title
Measurements
OG0001
OG0010
OG0020
OG0030
OG0040
OG0051
OG0060
ParticipantsOG00472
ParticipantsOG00570
ParticipantsOG00673
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0051
OG0060
ParticipantsOG00470
ParticipantsOG00567
ParticipantsOG00665
Title
Measurements
OG0000
OG0010
OG0020
OG0031
OG0040
OG0052
OG0061
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG0061
Title
Measurements
OG0000
OG0010
OG0020
OG0031
OG0040
OG0050
OG0060
ParticipantsOG00468
ParticipantsOG00565
ParticipantsOG00663
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0061
ParticipantsOG00468
ParticipantsOG00565
ParticipantsOG00662
Title
Measurements
OG0000
OG0010
OG0020
OG0033
OG0040
OG0050
OG0061
ParticipantsOG00470
ParticipantsOG00570
ParticipantsOG00672
Title
Measurements
OG0000
OG0011
OG0021
OG0030
OG0040
OG0050
OG0060
ParticipantsOG00467
ParticipantsOG00568
ParticipantsOG00665
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0061
ParticipantsOG00466
ParticipantsOG00563
ParticipantsOG00660
Title
Measurements
OG0001
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
6
OG0042
OG0051
OG0062
Participants
OG004
0
ParticipantsOG0053
ParticipantsOG0063
Title
Measurements
OG0000
OG0010
OG0021
OG0030
OG0040
OG0050
OG0061
Participants
OG004
0
ParticipantsOG0050
ParticipantsOG0060
Title
Measurements
OG0001
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
Participants
OG004
69
ParticipantsOG00566
ParticipantsOG00662
Title
Measurements
OG0007
OG0015
OG0024
OG0038
OG0044
OG0052
OG0066
Participants
OG004
2
ParticipantsOG0052
ParticipantsOG0061
Title
Measurements
OG0000
OG0011
OG0020
OG0030
OG0041
OG0050
OG0060
Participants
OG004
66
ParticipantsOG00564
ParticipantsOG00659
Title
Measurements
OG0002
OG0013
OG0028
OG00310
OG0045
OG0053
OG0063
114.33
(96.77 to 131.90)
OG004175.89(148.80 to 202.98)
Participants
OG004
65
Title
Measurements
OG00081.94(67.45 to 96.44)
OG001101.96(86.10 to 117.82)
OG002104.88(73.09 to 136.68)
OG003114.58(96.71 to 132.45)
OG004183.32(146.70 to 219.94)
Participants
OG004
1
Title
Measurements
OG000NA(NA to NA)NA indicates, data not quantifiable because the concentration was below limit of quantification.
OG00144.04(NA to NA)Only one participant was available at the time of analysis, confidence interval could not be calculated.
OG00260.98(-79.29 to 201.25)
OG00328.77(-227.64 to 285.18)
OG00440.33(NA to NA)Only one participant was available at the time of analysis, confidence interval could not be calculated.