Evaluation of AGN-150998 in Exudative Age-related Macular... | NCT01397409 | Trialant
NCT01397409
Sponsor
Allergan
Status
Completed
Last Update Posted
Apr 16, 2019Actual
Enrollment
271Actual
Phase
Phase 2
Conditions
Age-related Macular Degeneration
Interventions
AGN-150998
ranibizumab
Sham Injection
Countries
United States
Australia
Austria
France
Germany
Israel
Italy
Switzerland
Protocol Section
Identification Module
NCT ID
Results Section
Participant Flow Module
Pre-assignment Details
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
NCT01397409
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
150998-001
Secondary IDs
ID
Type
Description
Link
2011-002526-43
EudraCT Number
REACH Study
Other Identifier
Allergan, Inc.
Brief Title
Evaluation of AGN-150998 in Exudative Age-related Macular Degeneration (AMD)
Official Title
Not provided
Acronym
Not provided
Organization
AllerganINDUSTRY
Status Module
Record Verification Date
Apr 2019
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
Sep 1, 2011Actual
Primary Completion Date
Mar 31, 2014Actual
Completion Date
Apr 30, 2014Actual
First Submitted Date
Jul 18, 2011
First Submission Date that Met QC Criteria
Jul 18, 2011
First Posted Date
Jul 19, 2011Estimated
Results Waived
Not provided
Results First Submitted Date
Jun 2, 2015
Results First Submitted that Met QC Criteria
Jun 2, 2015
Results First Posted Date
Jun 18, 2015Estimated
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Apr 9, 2019
Last Update Posted Date
Apr 16, 2019Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
AllerganINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
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
This study is conducted in 3 stages. Stage 1 is an open-label, dose-escalation assessment of the safety of AGN-150998 administered as a single intravitreal injection to patients with advanced exudative Age-related Macular Degeneration (AMD). Stage 2 and Stage 3 are randomized, double-masked, comparisons of the safety and treatment effects on retinal edema and best-corrected visual acuity (BCVA) of AGN-150998 and ranibizumab in treatment-naive patients with exudative AMD. Study medication is administered as needed in Stage 2 and with a fixed-dosing schedule in Stage 3. The study objectives are (1) to identify the highest tolerated dose of AGN-150998, (2) to assess the safety and duration of treatment effects on retinal edema and BCVA, and (3) to characterize the systemic pharmacokinetic profile of AGN-150998.
Detailed Description
Not provided
Conditions Module
Conditions
Age-related Macular Degeneration
Keywords
Not provided
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
271Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Stage 1: AGN-150998 4.2 mg
Experimental
Stage 1: AGN-150998 4.2.mg given as a single intravitreal injection.
Drug: AGN-150998
Stage 1: AGN-150998 3.0 mg
Experimental
Stage 1: AGN-150998 3.0 mg given as a single intravitreal injection.
Drug: AGN-150998
Stage 1: AGN-150998 2.0 mg
Experimental
Stage 1: AGN-150998 2.0 mg given as a single intravitreal injection.
Drug: AGN-150998
Stage 1: AGN-150998 1.0 mg
Experimental
Stage 1: AGN-150998 1.0 mg given as a single intravitreal injection.
Drug: AGN-150998
Stage 2: AGN-150998 4.2 mg
Experimental
Stage 2: AGN-150998 4,2 mg (highest tolerated dose from Stage 1) given as a single intravitreal injection at baseline. A second intravitreal injection will be given by week 16.
Drug: AGN-150998
Stage 2: AGN-150998 3.0 mg
Interventions
Name
Type
Description
Arm Group Labels
Other Names
AGN-150998
Drug
AGN-150998 Intravitreal injection.
Stage 1: AGN-150998 1.0 mg
Stage 1: AGN-150998 2.0 mg
Stage 1: AGN-150998 3.0 mg
Stage 1: AGN-150998 4.2 mg
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Highest Tolerated Dose (HTD) of AGN-150998
Stage 1 evaluated the safety of a single intravitreal injection of AGN-150998 with doses ranging from 1.0 to 4.2 mg.
24 Weeks
Stage 1: Change From Baseline in Central Retinal Thickness (CRT) in the Study Eye
CRT was assessed using spectral domain optical coherence tomography (SD-OCT), a non-invasive diagnostic system providing high-resolution imaging sections of the retina. SD-OCT was performed in the study eye after pupil dilation. A negative change from Baseline indicated improvement.
Baseline, Week 4
Stage 2: Time Between Baseline Treatment and Recurrence of Active Disease
Recurrence of Active Disease was based on Best Corrected Visual Acuity (BCVA), Central Retinal Thickness (CRT) values as evaluated by the Central Reading Center (CRC) and the investigator assessments of haemorrhage.
Baseline, Week 16
Stage 3: Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye
BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. 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.
Baseline, Week 16
Secondary Outcomes
Measure
Description
Time Frame
Stage 2: Time Between Second Treatment and Recurrence of Active Disease
Recurrence of active disease is defined as the time in days to escape to standard of care. Time is calculated as (date of Escaping to Standard of Care/Censoring minus the date of the Second Injection) +1.
32 Weeks
Stage 2: Change From Baseline in Central Retinal Thickness (CRT) in the Study Eye
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Exudative age-related macular degeneration
Best-corrected visual acuity between 20/32 and 20/320 in the study eye
Exclusion Criteria:
Near-sightedness of 8 diopters or more
Uncontrolled glaucoma in the study eye
Cataract surgery or Lasik within the last 3 months
Callanan D, Kunimoto D, Maturi RK, Patel SS, Staurenghi G, Wolf S, Cheetham JK, Hohman TC, Kim K, Lopez FJ, Schneider S. Double-Masked, Randomized, Phase 2 Evaluation of Abicipar Pegol (an Anti-VEGF DARPin Therapeutic) in Neovascular Age-Related Macular Degeneration. J Ocul Pharmacol Ther. 2018 Dec;34(10):700-709. doi: 10.1089/jop.2018.0062. Epub 2018 Nov 9.
See Also Links
Not provided
Available IPD Information
Not provided
IPD Sharing Statement Module
No data available
No data is available for this block.
Not provided
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Stage 1: AGN-150998 4.2 mg
Stage 1: AGN-150998 4.2 mg given as a single intravitreal injection.
FG001
Stage 1: AGN-150998 3.0 mg
Stage 1: AGN-150998 3.0 mg given as a single intravitreal injection.
FG002
Stage 1: AGN-150998 2.0 mg
Stage 1: AGN-150998 2.0 mg given as a single intravitreal injection
FG003
Stage 1: AGN-150998 1.0 mg
Stage 1: AGN-150998 1.0 mg given as a single intravitreal injection.
FG004
Stage 2: AGN-150998 4.2 mg
Stage 2: AGN-150998 4.2 mg (highest tolerated dose from Stage 1) given as a single intravitreal injection at baseline. A second intravitreal injection will be given by week 16.
FG005
Stage 2: AGN-150998 3.0 mg
Stage 2: AGN-150998 3.0 mg (one dose below highest tolerated dose from Stage 1) given as a single intravitreal injection at baseline. A second intravitreal injection will be given by week 16.
FG006
Stage 2: Ranibizumab 0.5 mg
Stage 2: ranibizumab 0.5 mg given as a single intravitreal injection at baseline. A second intravitreal injection will be given by week 16.
FG007
Stage 3: AGN-150998 2.0 mg
Stage 3: AGN-150998 2.0 mg given as intravitreal injections at Baseline, Weeks 4 and 8, followed by sham injections at Weeks 12 and 16.
FG008
Stage 3: AGN-150998 1.0 mg
Stage 3: AGN-150998 1.0 mg given as intravitreal injections at Baseline, Weeks 4 and 8, followed by sham injections at Weeks 12 and 16.
FG009
Stage 3: Ranibizumab 0.5 mg
Stage 3: ranibizumab 0.5 mg given as intravitreal injections every 4 weeks for 16 weeks
Periods
Title
Milestones
Reasons Not Completed
Stage 1
Type
Comment
Milestone Data
STARTED
FG0009 subjects
FG0016 subjects
FG0026 subjects
FG0033 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
COMPLETED
FG0009 subjects
FG0016 subjects
FG0026 subjects
FG0033 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Stage 2
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Stage 3
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Stage 1: AGN-150998 4.2 mg
Stage 1: AGN-150998 4.2 mg given as a single intravitreal injection.
BG001
Stage 1: AGN-150998 3.0 mg
Stage 1: AGN-150998 3.0 mg given as a single intravitreal injection.
Denominators
Units
Counts
Participants
BG000
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Outcome Measures Module
Outcome Measures
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
Highest Tolerated Dose (HTD) of AGN-150998
Stage 1 evaluated the safety of a single intravitreal injection of AGN-150998 with doses ranging from 1.0 to 4.2 mg.
Safety population included all treated participants.
Posted
Number
mg
24 Weeks
ID
Title
Description
OG000
Stage 1 All Participants
Participants in Stage 1 received an intravitreal injection of AGN-150998 with doses ranging from 1.0 to 4.2 mg.
Units
Counts
Participants
Adverse Events Module
Frequency Threshold
5
Time Frame
Not provided
Description
Not provided
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
Stage 1: AGN-150998 4.2 mg
Stage 1: AGN-150998 4.2 mg given as a single intravitreal injection.
Stage 2: AGN-150998 3.0 mg (one dose below highest tolerated dose) from Stage 1 given as a single intravitreal injection at baseline. A second intravitreal injection will be given by week 16.
Drug: AGN-150998
Stage 2: ranibizumab 0.5 mg
Active Comparator
Stage 2: ranibizumab 0.5 mg given as a single intravitreal injection at baseline. A second intravitreal injection will be given by week 16.
Drug: ranibizumab
Stage 3: AGN-150998 2.0 mg
Experimental
Stage 3: AGN-150998 2.0 mg given as intravitreal injections at Baseline, Weeks 4 and 8, followed by sham injections at Weeks 12 and 16.
Drug: AGN-150998
Other: Sham Injection
Stage 3: AGN-150998 1.0 mg
Experimental
Stage 3: AGN-150998 1.0 mg given as intravitreal injections at Baseline, Weeks 4 and 8, followed by sham injections at Weeks 12 and 16.
Drug: AGN-150998
Other: Sham Injection
Stage 3: ranibizumab 0.5 mg
Active Comparator
Stage 3: ranibizumab 0.5 mg given as intravitreal injections every 4 weeks for 16 weeks.
Drug: ranibizumab
Stage 2: AGN-150998 3.0 mg
Stage 2: AGN-150998 4.2 mg
Stage 3: AGN-150998 1.0 mg
Stage 3: AGN-150998 2.0 mg
ranibizumab
Drug
Ranibizumab 0.5 mg given by intravitreal injection.
Stage 2: ranibizumab 0.5 mg
Stage 3: ranibizumab 0.5 mg
Lucentis®
Sham Injection
Other
Stage 3: Sham injection at Weeks 12 and 16.
Stage 3: AGN-150998 1.0 mg
Stage 3: AGN-150998 2.0 mg
CRT was assessed using spectral domain optical coherence tomography (SD-OCT), a non-invasive diagnostic system providing high-resolution imaging sections of the retina. SD-OCT was performed in the study eye after pupil dilation. A negative change from Baseline indicated improvement.
Baseline, Week 4
Stage 2: Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye
BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. 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.
Baseline, Week 4
Stage 3: Change From Baseline in Central Retinal Thickness (CRT) in the Study Eye
CRT was assessed using spectral domain optical coherence tomography (SD-OCT), a non-invasive diagnostic system providing high-resolution imaging sections of the retina. SD-OCT was performed in the study eye after pupil dilation. A negative change from Baseline indicated improvement.
Baseline, Week 4
Stage 3: Change From Baseline in BCVA in the Study Eye
BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. 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.
Baseline, Week 4
Sydney
New South Wales
Australia
Vienna
Austria
Créteil
France
Bonn
Germany
Tel Aviv
Israel
Florence
Italy
Binningen
Switzerland
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
0 subjects
FG00467 subjects
FG00558 subjects
FG00658 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG00459 subjects
FG00554 subjects
FG00658 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0048 subjects
FG0054 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0046 subjects
FG0053 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
Personal Reasons
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Other Miscellaneous Reasons
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
0 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG00723 subjects
FG00825 subjects
FG00916 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG00721 subjects
FG00825 subjects
FG00916 subjects
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0072 subjects
FG0080 subjects
FG0090 subjects
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0071 subjects
FG0080 subjects
FG0090 subjects
Other Miscellaneous Reasons
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
BG002
Stage 1: AGN-150998 2.0 mg
Stage 1: AGN-150998 2.0 mg given as a single intravitreal injection
BG003
Stage 1: AGN-150998 1.0 mg
Stage 1: AGN-150998 1.0 mg given as a single intravitreal injection.
BG004
Stage 2: AGN-150998 4.2 mg
Stage 2: AGN-150998 4.2 mg (highest tolerated dose from Stage 1) given as a single intravitreal injection at baseline. A second intravitreal injection will be given by week 16.
BG005
Stage 2: AGN-150998 3.0 mg
Stage 2: AGN-150998 3.0 mg (one dose below highest tolerated dose from Stage 1) given as a single intravitreal injection at baseline. A second intravitreal injection will be given by week 16.
BG006
Stage 2: Ranibizumab 0.5 mg
Stage 2: ranibizumab 0.5 mg given as a single intravitreal injection at baseline. A second intravitreal injection will be given by week 16.
BG007
Stage 3: AGN-150998 2.0 mg
Stage 3: AGN-150998 2.0 mg given as intravitreal injections at Baseline, Weeks 4 and 8, followed by sham injections at Weeks 12 and 16.
BG008
Stage 3: AGN-150998 1.0 mg
Stage 3: AGN-150998 1.0 mg given as intravitreal injections at Baseline, Weeks 4 and 8, followed by sham injections at Weeks 12 and 16.
BG009
Stage 3: Ranibizumab 0.5 mg
Stage 3: ranibizumab 0.5 mg given as intravitreal injections every 4 weeks for 16 weeks
BG010
Total
Total of all reporting groups
9
BG0016
BG0026
BG0033
BG00467
BG00558
BG00658
BG00723
BG00825
BG00916
BG010271
Full Range
Years
Title
Denominators
Categories
Title
Measurements
BG00082.3(68 to 89)
BG00175.3(62 to 86)
BG00279.3(72 to 91)
BG00367.7(64 to 71)
BG00480.4(58 to 95)
BG00578.6(63 to 94)
BG00678.5(59 to 92)
BG00777.9(67 to 89)
BG00875.5(54 to 91)
BG00976.5(53 to 86)
BG01077.2(53 to 95)
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0005
BG0012
BG0024
BG0032
BG00434
BG00535
BG00638
BG00713
BG00818
BG0098
BG010159
Male
BG0004
BG0014
BG0022
BG0031
BG004
OG00024
Title
Denominators
Categories
Title
Measurements
OG0004.2
Primary
Stage 1: Change From Baseline in Central Retinal Thickness (CRT) in the Study Eye
CRT was assessed using spectral domain optical coherence tomography (SD-OCT), a non-invasive diagnostic system providing high-resolution imaging sections of the retina. SD-OCT was performed in the study eye after pupil dilation. A negative change from Baseline indicated improvement.
Safety population included all treated participants.
Posted
Mean
Standard Deviation
microns
Baseline, Week 4
ID
Title
Description
OG000
Stage 1: AGN-150998 4.2 mg
Stage 1: AGN-150998 4.2 mg given as a single intravitreal injection.
OG001
Stage 1: AGN-150998 3.0 mg
Stage 1: AGN-150998 3.0 mg given as a single intravitreal injection
OG002
Stage 1: AGN-150998 2.0 mg
Stage 1: AGN-150998 2.0 mg given as a single intravitreal injection.
OG003
Stage 1: AGN-150998 1.0 mg
Stage 1: AGN-150998 1.0 mg given as a single intravitreal injection
Units
Counts
Participants
OG0009
OG0016
OG0026
OG003
Title
Denominators
Categories
Baseline
Title
Measurements
OG000527.6± 126.79
OG001540.3± 284.34
OG002500.3± 155.65
OG003
Primary
Stage 2: Time Between Baseline Treatment and Recurrence of Active Disease
Recurrence of Active Disease was based on Best Corrected Visual Acuity (BCVA), Central Retinal Thickness (CRT) values as evaluated by the Central Reading Center (CRC) and the investigator assessments of haemorrhage.
Per-protocol Population included all treated participants who received all scheduled treatments.
Posted
Median
Inter-Quartile Range
days
Baseline, Week 16
ID
Title
Description
OG000
Stage 2: AGN-150998 4.2 mg
Stage 2: AGN-150998 4.2 mg (highest tolerated dose from Stage 1) given as a single intravitreal injection at baseline. A second intravitreal injection will be given by week 16.
OG001
Stage 2: AGN-150998 3.0 mg
Stage 2: AGN-150998 3.0 mg (one dose below highest tolerated dose from Stage 1) given as a single intravitreal injection at baseline. A second intravitreal injection will be given by week 16.
OG002
Stage 2: Ranibizumab 0.5 mg
Stage 2: ranibizumab 0.5 mg given as a single intravitreal injection at baseline. A second intravitreal injection will be given by week 16.
Units
Counts
Participants
OG00065
OG00157
OG00257
Title
Denominators
Categories
Title
Measurements
OG00059.0(43.0 to 109.0)
OG00157.0(43.0 to 86.0)
OG00257.0(43.0 to 85.0)
Primary
Stage 3: Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye
BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. 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.
Modified-Intent-to-Treat (mITT) Population
Posted
Mean
Standard Deviation
letters
Baseline, Week 16
ID
Title
Description
OG000
Stage 3: AGN-150998 2.0 mg
Stage 3: AGN-150998 2.0 mg given as intravitreal injections at Baseline, Weeks 4 and 8, followed by sham injections at Weeks 12 and 16.
OG001
Stage 3: AGN-150998 1.0 mg
Stage 3: AGN-150998 1.0 mg given as intravitreal injections at Baseline, Weeks 4 and 8, followed by sham injections at Weeks 12 and 16
OG002
Stage 3: Ranibizumab 0.5 mg
Stage 3: ranibizumab 0.5 mg given as intravitreal injections every 4 weeks for 16 weeks.
Units
Counts
Participants
OG00023
OG00125
OG00216
Title
Denominators
Categories
Baseline
Title
Measurements
OG00058.5± 14.29
OG00158.4± 13.49
OG00260.4± 16.41
Change from Baseline at Week 16
Secondary
Stage 2: Time Between Second Treatment and Recurrence of Active Disease
Recurrence of active disease is defined as the time in days to escape to standard of care. Time is calculated as (date of Escaping to Standard of Care/Censoring minus the date of the Second Injection) +1.
mITT Population
Posted
Median
Inter-Quartile Range
days
32 Weeks
ID
Title
Description
OG000
Stage 2: AGN-150998 4.2 mg
Stage 2: AGN-150998 4.2 mg (highest tolerated dose from Stage 1) given as a single intravitreal injection at baseline. A second intravitreal injection will be given by week 16.
OG001
Stage 2: AGN-150998 3.0 mg
Stage 2: AGN-150998 3.0 mg (one dose below highest tolerated dose from Stage 1) given as a single intravitreal injection at baseline. A second intravitreal injection will be given by week 16.
OG002
Stage 2: Ranibizumab 0.5 mg
Stage 2: ranibizumab 0.5 mg given as a single intravitreal injection at baseline. A second intravitreal injection will be given by week 16.
Units
Counts
Participants
OG00062
OG00155
OG00258
Title
Denominators
Categories
Title
Measurements
OG00085.0(57.0 to 118.0)
OG001112.0(60.0 to NA)75% Upper Limit not estimated.
OG002111.0(57.0 to NA)75% Upper Limit not estimated.
Secondary
Stage 2: Change From Baseline in Central Retinal Thickness (CRT) in the Study Eye
CRT was assessed using spectral domain optical coherence tomography (SD-OCT), a non-invasive diagnostic system providing high-resolution imaging sections of the retina. SD-OCT was performed in the study eye after pupil dilation. A negative change from Baseline indicated improvement.
Per-protocol Population included all treated participants who received all scheduled treatments.
Posted
Mean
Standard Deviation
microns
Baseline, Week 4
ID
Title
Description
OG000
Stage 2: AGN-150998 4.2 mg
Stage 2: AGN-150998 4.2 mg (highest tolerated dose from Stage 1) given as a single intravitreal injection at baseline. A second intravitreal injection will be given by week 16.
OG001
Stage 2: AGN-150998 3.0 mg
Stage 2: AGN-150998 3.0 mg (one dose below highest tolerated dose from Stage 1) given as a single intravitreal injection at baseline. A second intravitreal injection will be given by week 16.
OG002
Stage 2: Ranibizumab 0.5 mg
Stage 2: ranibizumab 0.5 mg given as a single intravitreal injection at baseline. A second intravitreal injection will be given by week 16.
Units
Counts
Participants
OG00065
OG00157
OG00257
Title
Denominators
Categories
Baseline
Title
Measurements
OG000524.6± 170.71
OG001507.3± 139.88
OG002497.1± 122.04
Change from Baseline at Week 4 (n=61,56,57)
Secondary
Stage 2: Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye
BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. 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.
Per-protocol Population included all treated participants who received all scheduled treatments.
Posted
Mean
Standard Deviation
letters
Baseline, Week 4
ID
Title
Description
OG000
Stage 2: AGN-150998 4.2 mg
Stage 2: AGN-150998 4.2 mg (highest tolerated dose from Stage 1) given as a single intravitreal injection at baseline. A second intravitreal injection will be given by week 16.
OG001
Stage 2: AGN-150998 3.0 mg
Stage 2: AGN-150998 3.0 mg (one dose below highest tolerated dose from Stage 1) given as a single intravitreal injection at baseline. A second intravitreal injection will be given by week 16.
OG002
Stage 2: Ranibizumab 0.5 mg
Stage 2: ranibizumab 0.5 mg given as a single intravitreal injection at baseline. A second intravitreal injection will be given by week 16.
Units
Counts
Participants
OG00065
OG00157
OG00257
Title
Denominators
Categories
Baseline
Title
Measurements
OG00054.5± 13.90
OG00152.7± 12.62
OG00255.4± 13.00
Change from Baseline at Week 4 (n=62,56,57)
Secondary
Stage 3: Change From Baseline in Central Retinal Thickness (CRT) in the Study Eye
CRT was assessed using spectral domain optical coherence tomography (SD-OCT), a non-invasive diagnostic system providing high-resolution imaging sections of the retina. SD-OCT was performed in the study eye after pupil dilation. A negative change from Baseline indicated improvement.
Per-protocol Population included all treated participants who received all scheduled treatments.
Posted
Mean
Standard Deviation
microns
Baseline, Week 4
ID
Title
Description
OG000
Stage 3: AGN-150998 2.0 mg
Stage 3: AGN-150998 2.0 mg given as intravitreal injections at Baseline, Weeks 4 and 8, followed by sham injections at Weeks 12 and 16.
OG001
Stage 3: AGN-150998 1.0 mg
Stage 3: AGN-150998 1.0 mg given as intravitreal injections at Baseline, Weeks 4 and 8, followed by sham injections at Weeks 12 and 16
OG002
Stage 3: Ranibizumab 0.5 mg
Stage 3: ranibizumab 0.5 mg given as intravitreal injections every 4 weeks for 16 weeks.
Units
Counts
Participants
OG00023
OG00125
OG00216
Title
Denominators
Categories
Baseline
Title
Measurements
OG000466.0± 125.96
OG001526.1± 165.09
OG002463.3± 94.56
Change from Baseline at Week 4
Secondary
Stage 3: Change From Baseline in BCVA in the Study Eye
BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. 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.
Per-protocol Population included all treated participants who received all scheduled treatments.
Posted
Mean
Standard Deviation
letters
Baseline, Week 4
ID
Title
Description
OG000
Stage 3: AGN-150998 2.0 mg
Stage 3: AGN-150998 2.0 mg given as intravitreal injections at Baseline, Weeks 4 and 8, followed by sham injections at Weeks 12 and 16.
OG001
Stage 3: AGN-150998 1.0 mg
Stage 3: AGN-150998 1.0 mg given as intravitreal injections at Baseline, Weeks 4 and 8, followed by sham injections at Weeks 12 and 16
OG002
Stage 3: Ranibizumab 0.5 mg
Stage 3: ranibizumab 0.5 mg given as intravitreal injections every 4 weeks for 16 weeks.
Units
Counts
Participants
OG00023
OG00125
OG00216
Title
Denominators
Categories
Baseline
Title
Measurements
OG00058.5± 14.29
OG00158.4± 13.49
OG00260.4± 16.41
Change from Baseline at Week 4
0
9
3
9
EG001
Stage 1: AGN-150998 3.0 mg
Stage 1: AGN-150998 3.0 mg given as a single intravitreal injection.
0
6
5
6
EG002
Stage 1: AGN-150998 2.0 mg
Stage 1: AGN-150998 2.0 mg given as a single intravitreal injection
1
6
4
6
EG003
Stage 1: AGN-150998 1.0 mg
Stage 1: AGN-150998 1.0 mg given as a single intravitreal injection.
0
3
2
3
EG004
Stage 2: AGN-150998 4.2 mg
Stage 2: AGN-150998 4.2 mg (highest tolerated dose from Stage 1) given as a single intravitreal injection at baseline. A second intravitreal injection will be given by week 16.
11
67
51
67
EG005
Stage 2: AGN-150998 3.0 mg
Stage 2: AGN-150998 3.0 mg (one dose below highest tolerated dose from Stage 1) given as a single intravitreal injection at baseline. A second intravitreal injection will be given by week 16.
6
58
35
58
EG006
Stage 2: Ranibizumab 0.5 mg
Stage 2: ranibizumab 0.5 mg given as a single intravitreal injection at baseline. A second intravitreal injection will be given by week 16.
5
58
35
58
EG007
Stage 3: AGN-150998 2.0 mg
Stage 3: AGN-150998 2.0 mg given as intravitreal injections at Baseline, Weeks 4 and 8, followed by sham injections at Weeks 12 and 16.
0
23
10
23
EG008
Stage 3: AGN-150998 1.0 mg
Stage 3: AGN-150998 1.0 mg given as intravitreal injections at Baseline, Weeks 4 and 8, followed by sham injections at Weeks 12 and 16.
0
25
15
25
EG009
Stage 3: Ranibizumab 0.5 mg
Stage 3: ranibizumab 0.5 mg given as intravitreal injections every 4 weeks for 16 weeks
0
16
9
16
EG0000 affected9 at risk
EG0010 affected6 at risk
EG0021 affected6 at risk
EG0030 affected3 at risk
EG0040 affected67 at risk
EG0050 affected58 at risk
EG0061 affected58 at risk
EG0070 affected23 at risk
EG0080 affected25 at risk
EG0090 affected16 at risk
Renal failure acute
Renal and urinary disorders
MedDRA 16.0
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected6 at risk
EG0021 affected6 at risk
EG0030 affected3 at risk
EG0040 affected67 at risk
EG0050 affected58 at risk
EG0060 affected58 at risk
EG0070 affected23 at risk
EG0080 affected25 at risk
EG0090 affected16 at risk
Uveitus
Eye disorders
MedDRA 16.0
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG0030 affected3 at risk
EG0043 affected67 at risk
EG0052 affected58 at risk
EG0060 affected58 at risk
EG0070 affected23 at risk
EG0080 affected25 at risk
EG0090 affected16 at risk
Anterior chamber inflammation
Eye disorders
MedDRA 16.0
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG0030 affected3 at risk
EG0042 affected67 at risk
EG0050 affected58 at risk
EG0060 affected58 at risk
EG0070 affected23 at risk
EG0080 affected25 at risk
EG0090 affected16 at risk
Vitritis
Eye disorders
MedDRA 16.0
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG0030 affected3 at risk
EG0041 affected67 at risk
EG0051 affected58 at risk
EG0060 affected58 at risk
EG0070 affected23 at risk
EG0080 affected25 at risk
EG0090 affected16 at risk
Aortic valve stenosis
Cardiac disorders
MedDRA 16.0
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG0030 affected3 at risk
EG0041 affected67 at risk
EG0050 affected58 at risk
EG0060 affected58 at risk
EG0070 affected23 at risk
EG0080 affected25 at risk
EG0090 affected16 at risk
Cholecystitis acute
Hepatobiliary disorders
MedDRA 16.0
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG0030 affected3 at risk
EG0041 affected67 at risk
EG0050 affected58 at risk
EG0060 affected58 at risk
EG0070 affected23 at risk
EG0080 affected25 at risk
EG0090 affected16 at risk
Choroiditis
Eye disorders
MedDRA 16.0
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG0030 affected3 at risk
EG0041 affected67 at risk
EG0050 affected58 at risk
EG0060 affected58 at risk
EG0070 affected23 at risk
EG0080 affected25 at risk
EG0090 affected16 at risk
Endophthalmitis
Infections and infestations
MedDRA 16.0
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG0030 affected3 at risk
EG0041 affected67 at risk
EG0050 affected58 at risk
EG0060 affected58 at risk
EG0070 affected23 at risk
EG0080 affected25 at risk
EG0090 affected16 at risk
Glaucoma
Eye disorders
MedDRA 16.0
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG0030 affected3 at risk
EG0041 affected67 at risk
EG0050 affected58 at risk
EG0060 affected58 at risk
EG0070 affected23 at risk
EG0080 affected25 at risk
EG0090 affected16 at risk
Optic ischaemic neuropathy
Eye disorders
MedDRA 16.0
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG0030 affected3 at risk
EG0041 affected67 at risk
EG0050 affected58 at risk
EG0060 affected58 at risk
EG0070 affected23 at risk
EG0080 affected25 at risk
EG0090 affected16 at risk
Pancreatitis acute
Gastrointestinal disorders
MedDRA 16.0
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG0030 affected3 at risk
EG0041 affected67 at risk
EG0050 affected58 at risk
EG0060 affected58 at risk
EG0070 affected23 at risk
EG0080 affected25 at risk
EG0090 affected16 at risk
Rectal adenocarcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 16.0
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG0030 affected3 at risk
EG0041 affected67 at risk
EG0050 affected58 at risk
EG0060 affected58 at risk
EG0070 affected23 at risk
EG0080 affected25 at risk
EG0090 affected16 at risk
Retinal artery occlusion
Eye disorders
MedDRA 16.0
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG0030 affected3 at risk
EG0041 affected67 at risk
EG0050 affected58 at risk
EG0060 affected58 at risk
EG0070 affected23 at risk
EG0080 affected25 at risk
EG0090 affected16 at risk
Temporal arteritis
Vascular disorders
MedDRA 16.0
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG0030 affected3 at risk
EG0041 affected67 at risk
EG0050 affected58 at risk
EG0060 affected58 at risk
EG0070 affected23 at risk
EG0080 affected25 at risk
EG0090 affected16 at risk
Angina pectoris
Cardiac disorders
MedDRA 16.0
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG0030 affected3 at risk
EG0040 affected67 at risk
EG0051 affected58 at risk
EG0060 affected58 at risk
EG0070 affected23 at risk
EG0080 affected25 at risk
EG0090 affected16 at risk
Atypical pneumonia
Infections and infestations
MedDRA 16.0
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG0030 affected3 at risk
EG0040 affected67 at risk
EG0051 affected58 at risk
EG0060 affected58 at risk
EG0070 affected23 at risk
EG0080 affected25 at risk
EG0090 affected16 at risk
Cerebrovascular accident
Nervous system disorders
MedDRA 16.0
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG0030 affected3 at risk
EG0040 affected67 at risk
EG0051 affected58 at risk
EG0060 affected58 at risk
EG0070 affected23 at risk
EG0080 affected25 at risk
EG0090 affected16 at risk
Duodenal ulcer haemorrhage
Gastrointestinal disorders
MedDRA 16.0
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG0030 affected3 at risk
EG0040 affected67 at risk
EG0051 affected58 at risk
EG0060 affected58 at risk
EG0070 affected23 at risk
EG0080 affected25 at risk
EG0090 affected16 at risk
Gastric ulcer haemorrhage
Gastrointestinal disorders
MedDRA 16.0
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG0030 affected3 at risk
EG0040 affected67 at risk
EG0050 affected58 at risk
EG0061 affected58 at risk
EG0070 affected23 at risk
EG0080 affected25 at risk
EG0090 affected16 at risk
Myocardial infarction
Cardiac disorders
MedDRA 16.0
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG0030 affected3 at risk
EG0040 affected67 at risk
EG0050 affected58 at risk
EG0061 affected58 at risk
EG0070 affected23 at risk
EG0080 affected25 at risk
EG0090 affected16 at risk
Rectal cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 16.0
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG0030 affected3 at risk
EG0040 affected67 at risk
EG0050 affected58 at risk
EG0061 affected58 at risk
EG0070 affected23 at risk
EG0080 affected25 at risk
EG0090 affected16 at risk
Renal cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 16.0
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG0030 affected3 at risk
EG0040 affected67 at risk
EG0050 affected58 at risk
EG0061 affected58 at risk
EG0070 affected23 at risk
EG0080 affected25 at risk
EG0090 affected16 at risk
Squamous cell carcinoma of skin
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 16.0
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG0030 affected3 at risk
EG0040 affected67 at risk
EG0050 affected58 at risk
EG0061 affected58 at risk
EG0070 affected23 at risk
EG0080 affected25 at risk
EG0090 affected16 at risk
EG0000 affected9 at risk
EG0011 affected6 at risk
EG0020 affected6 at risk
EG0030 affected3 at risk
EG0040 affected67 at risk
EG0050 affected58 at risk
EG0060 affected58 at risk
EG0070 affected23 at risk
EG0080 affected25 at risk
EG0090 affected16 at risk
Ventricular extrasystoles
Cardiac disorders
MedDRA 16.0
Systematic Assessment
EG0000 affected9 at risk
EG0011 affected6 at risk
EG0020 affected6 at risk
EG0030 affected3 at risk
EG0040 affected67 at risk
EG0050 affected58 at risk
EG0060 affected58 at risk
EG0070 affected23 at risk
EG0080 affected25 at risk
EG0090 affected16 at risk
Anterior chamber inflammation
Eye disorders
MedDRA 16.0
Systematic Assessment
EG0001 affected9 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG0030 affected3 at risk
EG0042 affected67 at risk
EG0051 affected58 at risk
EG0060 affected58 at risk
EG0070 affected23 at risk
EG0080 affected25 at risk
EG0090 affected16 at risk
Retinal pigment epithelial tear
Eye disorders
MedDRA 16.0
Systematic Assessment
EG0001 affected9 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG0030 affected3 at risk
EG0041 affected67 at risk
EG0051 affected58 at risk
EG0060 affected58 at risk
EG0071 affected23 at risk
EG0081 affected25 at risk
EG0090 affected16 at risk
Conjunctival haemorrhage
Eye disorders
MedDRA 16.0
Systematic Assessment
EG0000 affected9 at risk
EG0011 affected6 at risk
EG0021 affected6 at risk
EG0031 affected3 at risk
EG0049 affected67 at risk
EG0053 affected58 at risk
EG0065 affected58 at risk
EG0071 affected23 at risk
EG0082 affected25 at risk
EG0090 affected16 at risk
Eye irritation
Eye disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 affected9 at risk
EG0011 affected6 at risk
EG0021 affected6 at risk
EG0030 affected3 at risk
EG0045 affected67 at risk
EG0052 affected58 at risk
EG0062 affected58 at risk
EG0071 affected23 at risk
EG0081 affected25 at risk
EG0090 affected16 at risk
Anterior chamber cell
Eye disorders
MedDRA 16.0
Systematic Assessment
EG0000 affected9 at risk
EG0011 affected6 at risk
EG0020 affected6 at risk
EG0030 affected3 at risk
EG0042 affected67 at risk
EG0050 affected58 at risk
EG0060 affected58 at risk
EG0070 affected23 at risk
EG0080 affected25 at risk
EG0090 affected16 at risk
Anterior chamber flare
Eye disorders
MedDRA 16.0
Systematic Assessment
EG0000 affected9 at risk
EG0011 affected6 at risk
EG0020 affected6 at risk
EG0030 affected3 at risk
EG0040 affected67 at risk
EG0050 affected58 at risk
EG0060 affected58 at risk
EG0070 affected23 at risk
EG0080 affected25 at risk
EG0090 affected16 at risk
Eye pain
Eye disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 affected9 at risk
EG0011 affected6 at risk
EG0020 affected6 at risk
EG0030 affected3 at risk
EG0046 affected67 at risk
EG0053 affected58 at risk
EG0064 affected58 at risk
EG0072 affected23 at risk
EG0081 affected25 at risk
EG0091 affected16 at risk
Hyalosis asteroid
Eye disorders
MedDRA 16.0
Systematic Assessment
EG0000 affected9 at risk
EG0011 affected6 at risk
EG0020 affected6 at risk
EG0030 affected3 at risk
EG0040 affected67 at risk
EG0050 affected58 at risk
EG0060 affected58 at risk
EG0070 affected23 at risk
EG0080 affected25 at risk
EG0090 affected16 at risk
Macular oedema
Eye disorders
MedDRA 16.0
Systematic Assessment
EG0000 affected9 at risk
EG0011 affected6 at risk
EG0020 affected6 at risk
EG0030 affected3 at risk
EG0040 affected67 at risk
EG0050 affected58 at risk
EG0060 affected58 at risk
EG0070 affected23 at risk
EG0080 affected25 at risk
EG0090 affected16 at risk
Foreign body sensation in eyes
Eye disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 affected9 at risk
EG0010 affected6 at risk
EG0021 affected6 at risk
EG0030 affected3 at risk
EG0044 affected67 at risk
EG0050 affected58 at risk
EG0061 affected58 at risk
EG0070 affected23 at risk
EG0081 affected25 at risk
EG0091 affected16 at risk
Retinal haemorrhage
Eye disorders
MedDRA 16.0
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG0031 affected3 at risk
EG0046 affected67 at risk
EG0053 affected58 at risk
EG0064 affected58 at risk
EG0070 affected23 at risk
EG0083 affected25 at risk
EG0092 affected16 at risk
Urinary tract infection
Infections and infestations
MedDRA 16.0
Systematic Assessment
EG0001 affected9 at risk
EG0011 affected6 at risk
EG0020 affected6 at risk
EG0030 affected3 at risk
EG0041 affected67 at risk
EG0050 affected58 at risk
EG0062 affected58 at risk
EG0071 affected23 at risk
EG0080 affected25 at risk
EG0090 affected16 at risk
Nasopharyngitis
Infections and infestations
MedDRA 16.0
Systematic Assessment
EG0001 affected9 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG0030 affected3 at risk
EG0044 affected67 at risk
EG0052 affected58 at risk
EG0061 affected58 at risk
EG0070 affected23 at risk
EG0080 affected25 at risk
EG0091 affected16 at risk
Viral upper respiratory tract infection
Infections and infestations
MedDRA 16.0
Systematic Assessment
EG0000 affected9 at risk
EG0011 affected6 at risk
EG0020 affected6 at risk
EG0030 affected3 at risk
EG0040 affected67 at risk
EG0050 affected58 at risk
EG0060 affected58 at risk
EG0070 affected23 at risk
EG0080 affected25 at risk
EG0090 affected16 at risk
Laceration
Injury, poisoning and procedural complications
MedDRA 16.0
Non-systematic Assessment
EG0000 affected9 at risk
EG0010 affected6 at risk
EG0021 affected6 at risk
EG0030 affected3 at risk
EG0040 affected67 at risk
EG0050 affected58 at risk
EG0061 affected58 at risk
EG0070 affected23 at risk
EG0080 affected25 at risk
EG0090 affected16 at risk
Respiratory tract congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 affected9 at risk
EG0011 affected6 at risk
EG0020 affected6 at risk
EG0030 affected3 at risk
EG0040 affected67 at risk
EG0050 affected58 at risk
EG0060 affected58 at risk
EG0070 affected23 at risk
EG0080 affected25 at risk
EG0090 affected16 at risk
Vitreous detachment
Eye disorders
MedDRA 16.0
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG0030 affected3 at risk
EG0045 affected67 at risk
EG0056 affected58 at risk
EG0062 affected58 at risk
EG0072 affected23 at risk
EG0082 affected25 at risk
EG0090 affected16 at risk
Visual acuity reduced
Eye disorders
MedDRA 16.0
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG0030 affected3 at risk
EG0045 affected67 at risk
EG0053 affected58 at risk
EG0063 affected58 at risk
EG0070 affected23 at risk
EG0080 affected25 at risk
EG0090 affected16 at risk
Iron deficiency anaemia
Blood and lymphatic system disorders
MedDRA 16.0
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG0030 affected3 at risk
EG0040 affected67 at risk
EG0050 affected58 at risk
EG0060 affected58 at risk
EG0070 affected23 at risk
EG0080 affected25 at risk
EG0091 affected16 at risk
Vitritis
Eye disorders
MedDRA 16.0
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG0030 affected3 at risk
EG0040 affected67 at risk
EG0053 affected58 at risk
EG0060 affected58 at risk
EG0070 affected23 at risk
EG0081 affected25 at risk
EG0090 affected16 at risk
Vitreous floaters
Eye disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 affected9 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG0030 affected3 at risk
EG0041 affected67 at risk
EG0053 affected58 at risk
EG0060 affected58 at risk
EG0071 affected23 at risk
EG0083 affected25 at risk
EG0091 affected16 at risk
Dry eye
Eye disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 affected9 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG0030 affected3 at risk
EG0040 affected67 at risk
EG0053 affected58 at risk
EG0061 affected58 at risk
EG0070 affected23 at risk
EG0080 affected25 at risk
EG0090 affected16 at risk
Influenza
Infections and infestations
MedDRA 16.0
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG0030 affected3 at risk
EG0040 affected67 at risk
EG0051 affected58 at risk
EG0063 affected58 at risk
EG0070 affected23 at risk
EG0080 affected25 at risk
EG0092 affected16 at risk
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 affected9 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG0030 affected3 at risk
EG0044 affected67 at risk
EG0052 affected58 at risk
EG0062 affected58 at risk
EG0071 affected23 at risk
EG0080 affected25 at risk
EG0090 affected16 at risk
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 affected9 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG0030 affected3 at risk
EG0041 affected67 at risk
EG0053 affected58 at risk
EG0061 affected58 at risk
EG0070 affected23 at risk
EG0080 affected25 at risk
EG0091 affected16 at risk
Headache
Nervous system disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 affected9 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG0030 affected3 at risk
EG0041 affected67 at risk
EG0053 affected58 at risk
EG0063 affected58 at risk
EG0071 affected23 at risk
EG0080 affected25 at risk
EG0091 affected16 at risk
Age-related macular degeneration
Eye disorders
MedDRA 16.0
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG0030 affected3 at risk
EG0042 affected67 at risk
EG0051 affected58 at risk
EG0060 affected58 at risk
EG0070 affected23 at risk
EG0081 affected25 at risk
EG0091 affected16 at risk
Macular scar
Eye disorders
MedDRA 16.0
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG0030 affected3 at risk
EG0040 affected67 at risk
EG0050 affected58 at risk
EG0060 affected58 at risk
EG0070 affected23 at risk
EG0080 affected25 at risk
EG0092 affected16 at risk
Choroidal neovascularisation
Eye disorders
MedDRA 16.0
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG0030 affected3 at risk
EG0042 affected67 at risk
EG0050 affected58 at risk
EG0062 affected58 at risk
EG0070 affected23 at risk
EG0080 affected25 at risk
EG0091 affected16 at risk
Eye pruritus
Eye disorders
MedDRA 16.0
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG0030 affected3 at risk
EG0041 affected67 at risk
EG0051 affected58 at risk
EG0060 affected58 at risk
EG0070 affected23 at risk
EG0080 affected25 at risk
EG0091 affected16 at risk
Ocular discomfort
Eye disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 affected9 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG0030 affected3 at risk
EG0040 affected67 at risk
EG0052 affected58 at risk
EG0060 affected58 at risk
EG0070 affected23 at risk
EG0080 affected25 at risk
EG0091 affected16 at risk
Visual impairment
Eye disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 affected9 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG0030 affected3 at risk
EG0040 affected67 at risk
EG0051 affected58 at risk
EG0061 affected58 at risk
EG0070 affected23 at risk
EG0080 affected25 at risk
EG0091 affected16 at risk
Upper respiratory tract infection
Infections and infestations
MedDRA 16.0
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG0030 affected3 at risk
EG0041 affected67 at risk
EG0051 affected58 at risk
EG0062 affected58 at risk
EG0071 affected23 at risk
EG0080 affected25 at risk
EG0091 affected16 at risk
Bronchitis
Infections and infestations
MedDRA 16.0
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG0030 affected3 at risk
EG0041 affected67 at risk
EG0052 affected58 at risk
EG0061 affected58 at risk
EG0070 affected23 at risk
EG0080 affected25 at risk
EG0091 affected16 at risk
Contusion
Injury, poisoning and procedural complications
MedDRA 16.0
Non-systematic Assessment
EG0000 affected9 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG0030 affected3 at risk
EG0040 affected67 at risk
EG0050 affected58 at risk
EG0060 affected58 at risk
EG0070 affected23 at risk
EG0080 affected25 at risk
EG0091 affected16 at risk
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 affected9 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG0030 affected3 at risk
EG0040 affected67 at risk
EG0050 affected58 at risk
EG0060 affected58 at risk
EG0070 affected23 at risk
EG0080 affected25 at risk
EG0091 affected16 at risk
Urticaria
Skin and subcutaneous tissue disorders
MedDRA 16.0
Non-systematic Assessment
EG0000 affected9 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG0030 affected3 at risk
EG0040 affected67 at risk
EG0050 affected58 at risk
EG0060 affected58 at risk
EG0070 affected23 at risk
EG0080 affected25 at risk
EG0091 affected16 at risk
Hypertension
Vascular disorders
MedDRA 16.0
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG0030 affected3 at risk
EG0042 affected67 at risk
EG0050 affected58 at risk
EG0060 affected58 at risk
EG0071 affected23 at risk
EG0080 affected25 at risk
EG0091 affected16 at risk
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA 16.0
Systematic Assessment
EG0000 affected9 at risk
EG0010 affected6 at risk
EG0021 affected6 at risk
EG0030 affected3 at risk
EG0042 affected67 at risk
EG0050 affected58 at risk
EG0060 affected58 at risk
EG0070 affected23 at risk
EG0080 affected25 at risk
EG0090 affected16 at risk
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.