Multicenter 12 Months Clinical Study to Evaluate Efficacy... | NCT01594281 | Trialant
NCT01594281
Sponsor
Novartis Pharmaceuticals
Status
Completed
Last Update Posted
Mar 15, 2019Actual
Enrollment
107Actual
Phase
Phase 2
Conditions
Proliferative Diabetic Retinopathy (PDR)
Interventions
Ranibizumab 0.5 mg
Panretinal laser photocoagulation
Countries
Germany
Protocol Section
Identification Module
NCT ID
NCT01594281
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
CRFB002DDE21
Secondary IDs
ID
Type
Description
Link
2011-005542-35
EudraCT Number
Brief Title
Multicenter 12 Months Clinical Study to Evaluate Efficacy and Safety of Ranibizumab Alone or in Combination With Laser Photocoagulation vs. Laser Photocoagulation Alone in Proliferative Diabetic Retinopathy (PRIDE)
Official Title
Multicenter Randomized Open-label Three-arms Controlled 12 Months Clinical Proof of Concept Study to Evaluate Efficacy and Safety of Ranibizumab Alone or in Combination With Laser Photocoagulation vs. Laser Photocoagulation Alone in Proliferative Diabetic Retinopathy
Acronym
PRIDE
Organization
NovartisINDUSTRY
Status Module
Record Verification Date
Nov 2018
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
Dec 11, 2012Actual
Primary Completion Date
Nov 30, 2016Actual
Completion Date
Dec 5, 2017Actual
First Submitted Date
May 3, 2012
First Submission Date that Met QC Criteria
May 7, 2012
First Posted Date
May 9, 2012Estimated
Results Waived
Not provided
Results First Submitted Date
Nov 19, 2018
Results First Submitted that Met QC Criteria
Nov 20, 2018
Results First Posted Date
Mar 15, 2019Actual
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
Nov 20, 2018
Last Update Posted Date
Mar 15, 2019Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Novartis PharmaceuticalsINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Not provided
Is FDA Regulated Drug
No
Is FDA Regulated Device
No
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 was to assess the efficacy and safety of the anti-Vascular Endothelial Growth Factor (VEGF) agent ranibizumab (0.5 mg) with or without Panretinal laser photocoagulation (PRP) compared to PRP alone in patients with Proliferative Diabetic Retinopathy (PDR).
Detailed Description
A 12-month core phase was followed by a 12-month observational follow-up phase (physician's routine), for a planned individual study duration of 24-25 months. A separate informed consent was signed for the 12-month observational follow-up phase. This study was conducted in Germany.
Conditions Module
Conditions
Proliferative Diabetic Retinopathy (PDR)
Keywords
Panretinal photocoagulation
Ranibizumab
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
107Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Ranibizumab mono
Experimental
Interventional Core Phase: One intravitreal injection of ranibizumab 0.5 mg to the study eye monthly until stability regarding morphological parameters is confirmed (ie, no further improvement of morphology or no worsening of morphology for 3 consecutive months)
Drug: Ranibizumab 0.5 mg
PRP mono
Active Comparator
Interventional Core Phase: Panretinal laser photocoagulation (PRP) treatment administered to the study eye in accordance with the modified diabetic retinopathy study (DRS) guidelines for panretinal laser photocoagulation procedures
Procedure: Panretinal laser photocoagulation
Ranibizumab+PRP
Experimental
Interventional Core Phase: Ranibizumab 0.5 mg as described for the ranibizumab mono arm and PRP treatment as described for the PRP mono arm until stability regarding morphological parameters is confirmed
Drug: Ranibizumab 0.5 mg
Procedure: Panretinal laser photocoagulation
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Ranibizumab 0.5 mg
Drug
Pre-filled syringe for intravitreal injection
Ranibizumab mono
Ranibizumab+PRP
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Change From Baseline in Area of Neovascularizations (NVs) at End of Core Study (EOCS)
The area of neovascularizations (NV) was assessed by a central reading center via fluorescein angiography (FA) images. The area of NV was calculated as the sum of area of neovascularization of the disc (NVD) and neovascularization elsewhere (NVE) and was recorded in square millimeters. A higher positive change value may indicate a greater formation of new, abnormal blood vessels and thus disease progression. One eye (study eye) contributed to the analysis.
Baseline, EOCS
Secondary Outcomes
Measure
Description
Time Frame
Change From Baseline in Area of Neovascularizations (NVs) at Month 3
The area of neovascularizations (NV) was assessed by a central reading center via fluorescein angiography (FA) images. The area of NV was calculated as the sum of area of neovascularization of the disc (NVD) and neovascularization elsewhere (NVE) and was recorded in square millimeters. A higher positive change value may indicate a greater formation of new, abnormal blood vessels and thus disease progression. One eye (study eye) contributed to the analysis.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Proliferative Diabetic Retinopathy
Best Corrected Visual Acuity (BCVA) in study eye of at least 20 Early Treatment Diabetic Retinopathy Study (ETDRS) letters (20/400)
Type 1 or type 2 diabetes under medical surveillance / with stabilized treatment
Exclusion Criteria:
Proliferative vitreoretinopathy in study eye
Clinically significant macular edema (CSME) in the study eye
Clinically non significant macular edema (CNSME) that is likely to develop to CSME in the study eye
Uncontrolled glaucoma in either eye
Other protocol-specified conditions
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 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
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Study Director
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Novartis Investigative Site
Aachen
52074
Germany
Novartis Investigative Site
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
Plan to Share IPD
Undecided
Description
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com.
Types
Not provided
Time Frame
Not provided
Access Criteria
Not provided
URL
Not provided
Results Section
Participant Flow Module
Pre-assignment Details
The number of patients in the protocol section (107) excludes one patient in the Ranibizumab mono arm who withdrew prior to the baseline visit. The number of patients in the Randomized Set (108) includes this patient. A separate Informed Consent was signed for the Non-Interventional Follow Up Phase
Recruitment Details
Patients were screened for eligibility at 23 German study sites and randomized at 22 of the 23 sites.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Ranibizumab Mono
Interventional Core Phase: One intravitreal injection of ranibizumab 0.5 mg to the study eye monthly until stability regarding morphological parameters is confirmed (ie, no further improvement of morphology or no worsening of morphology for 3 consecutive months)
Non-interventional Follow-Up Phase: Treatment per physician´s routine standard of care until Month 24
Periods
Title
Milestones
Reasons Not Completed
Interventional Core Phase
Type
Comment
Milestone Data
STARTED
All randomized patients, including one patient who withdrew prior to the baseline visit
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
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
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
No data available
No data is available for this block.
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
An open-label design was chosen in which the evaluation of the primary objective was performed by a reading center. The reading center that evaluated the primary and several secondary objectives was blinded to randomization and therefore assessed these objectives uninfluenced by treatment information. However, laser burns were visible on the images, and no full blinding regarding panretinal laser photocoagulation (PRP) was possible for the reading center.
Who Masked
Not provided
Lucentis®
RFB002
Panretinal laser photocoagulation
Procedure
PRP treatment following DRS guidelines
PRP mono
Ranibizumab+PRP
PRP
Baseline, Month 3
Best Corrected Visual Acuity (BCVA) (ETDRS Letters) at EOCS
BCVA was assessed using Early Treatment Diabetic Retinopathy Study (ETDRS)-like charts at a testing distance of 4 meters. A higher number of ETDRS letters may indicate better visual acuity. One eye (study eye) contributed to the analysis.
EOCS
Percentage of Patients With Change From Baseline in BCVA (ETDRS Letters) at EOCS
BCVA was assessed using Early Treatment Diabetic Retinopathy Study (ETDRS)-like charts at a testing distance of 4 meters. No clinically relevant change was defined as <5 letters gain or loss. A higher positive change value may indicate a greater improvement in visual acuity. One eye (study eye) contributed to the analysis.
Baseline, EOCS
Number of Patients With Change From Baseline in ETDRS Severity Grade of Diabetic Retinopathy (DR) at EOCS
The severity level of diabetic retinopathy was determined using the ETDRS severity scale. However, in contrast to the original ETDRS severity scale, wide field fluorescein angiography images were used in addition to color fundus photography for identification of NVs and prior PRP treatment was not considered for determining the severity level. Eyes could be graded in the following classes: "DR absent" (10), "questionable DR" (14,15), "NPDR" (20-53), "mild PDR" (60-61), "moderate PDR" (65), "high risk PDR" (71-75), "advanced PDR" (81-85) and "cannot grade" (90). One eye (study eye) contributed to the analysis. No statistical analysis was conducted for ≥ 1 class deterioration or ≥ 2 class deterioration from Baseline at EOCS because ratios could not be calculated in case of zero frequencies in at least one of the three treatment groups.
Baseline, EOCS
Change From Baseline in Central Subfield Thickness at EOCS
Central subfield retinal thickness was assessed by a central reading center using Optical Coherence Tomography images. A positive change value may indicate disease progression. One eye (study eye) contributed to the analysis.
Baseline, EOCS
Change From Baseline in Foveal Center Point Retinal Thickness at EOCS
Foveal center point retinal thickness was assessed by a central reading center using Optical Coherence Tomography images. A positive change value may indicate disease progression. One eye (study eye) contributed to the analysis.
Baseline, EOCS
Number of Ranibizumab Injections Until EOCS
The total number of ranibizumab injections until EOCS was calculated. One eye (study eye) contributed to the analysis. No statistical analysis was conducted.
Baseline to EOCS
Number of PRP Laser Spots Until EOCS
The total number of PRP laser spots from baseline until EOCS was calculated. One eye (study eye) contributed to the analysis. No statistical analysis was conducted.
Baseline to EOCS
Augsburg
86156
Germany
Novartis Investigative Site
Berlin
12203
Germany
Novartis Investigative Site
Cologne
51109
Germany
Novartis Investigative Site
Darmstadt
64297
Germany
Novartis Investigative Site
Düsseldorf
40225
Germany
Novartis Investigative Site
Essen
45122
Germany
Novartis Investigative Site
Freiburg im Breisgau
79106
Germany
Novartis Investigative Site
Glauchau
08371
Germany
Novartis Investigative Site
Göttingen
37075
Germany
Novartis Investigative Site
Hamburg
20246
Germany
Novartis Investigative Site
Hösbach
63768
Germany
Novartis Investigative Site
Karlsruhe
76133
Germany
Novartis Investigative Site
Leipzig
04103
Germany
Novartis Investigative Site
Mainz
55131
Germany
Novartis Investigative Site
Marburg
35039
Germany
Novartis Investigative Site
München
80336
Germany
Novartis Investigative Site
München
81675
Germany
Novartis Investigative Site
Münster
48145
Germany
Novartis Investigative Site
Münster
48149
Germany
Novartis Investigative Site
Regensburg
93042
Germany
Novartis Investigative Site
Tübingen
72076
Germany
Novartis Investigative Site
Ulm
89075
Germany
FG001
PRP Mono
Interventional Core Phase: Panretinal laser photocoagulation (PRP) treatment administered to the study eye in accordance with the modified diabetic retinopathy study (DRS) guidelines for panretinal laser photocoagulation procedures. If stability of morphological parameters could not be confirmed after 3 months, additional laser treatment was initiated.
Non-Interventional Follow-Up Phase: Treatment per physician´s routine standard of care until Month 24.
FG002
Ranibizumab+PRP
Interventional Core Phase: Ranibizumab 0.5 mg as described for the ranibizumab mono arm and PRP treatment as described for the PRP mono arm until stability regarding morphological parameters is confirmed
Non-interventional Follow-Up Phase: Treatment per physician´s routine standard of care until Month 24
FG00036 subjects
FG00136 subjects
FG00236 subjects
Full Analysis Set (FAS)
All randomized patients with at least one study treatment and one post-baseline assessment
FG00035 subjects
FG00135 subjects
FG00236 subjects
COMPLETED
End of Core Study (EOCS), defined as the last visit under therapy, up to Month 12
FG00029 subjects
FG00126 subjects
FG00228 subjects
NOT COMPLETED
FG0007 subjects
FG00110 subjects
FG0028 subjects
Type
Comment
Reasons
Protocol Deviation
FG0001 subjects
FG0010 subjects
FG0020 subjects
Subject Withdrew Consent
FG0000 subjects
FG0011 subjects
FG0021 subjects
Death
FG0001 subjects
FG0011 subjects
FG0022 subjects
Lost to Follow-up
FG0001 subjects
FG0014 subjects
FG0021 subjects
Adverse Event
FG0004 subjects
FG0014 subjects
FG0024 subjects
Non-Interventional Follow Up Phase
Type
Comment
Milestone Data
STARTED
All patients signing an Informed Consent, including one patient who withdrew without documented data
FG00028 subjects1 patient exited after completing Core Phase and did not start the Follow-Up Phase
FG00121 subjects5 patients exited after completing Core Phase and did not start the Follow-Up Phase
FG00225 subjects3 patients exited after completing Core Phase and did not start the Follow-Up Phase
Follow Up Set (FUS)
All patients with documented data in the follow up phase
FG00028 subjects
FG00120 subjects
FG00225 subjects
COMPLETED
FG00025 subjects
FG00119 subjects
FG00223 subjects
NOT COMPLETED
FG0003 subjects
FG0012 subjects
FG0022 subjects
Type
Comment
Reasons
Lost to Follow-up
FG0002 subjects
FG0012 subjects
FG0020 subjects
Administrative Problems
FG000
Safety Set
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Ranibizumab Mono
Interventional Core Phase: One intravitreal injection of ranibizumab 0.5 mg to the study eye monthly until stability regarding morphological parameters is confirmed (ie, no further improvement of morphology or no worsening of morphology for 3 consecutive months)
Non-interventional Follow-Up Phase: Treatment per physician´s routine standard of care until Month 24
BG001
PRP Mono
Interventional Core Phase: Panretinal laser photocoagulation (PRP) treatment administered to the study eye in accordance with the modified diabetic retinopathy study (DRS) guidelines for panretinal laser photocoagulation procedures. If stability of morphological parameters could not be confirmed after 3 months, additional laser treatment was initiated.
Non-Interventional Follow-Up Phase: Treatment per physician´s routine standard of care until Month 24.
BG002
Ranibizumab+PRP
Interventional Core Phase: Ranibizumab 0.5 mg as described for the ranibizumab mono arm and PRP treatment as described for the PRP mono arm until stability regarding morphological parameters is confirmed
Non-interventional Follow-Up Phase: Treatment per physician´s routine standard of care until Month 24
BG003
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00035
BG00135
BG00236
BG003106
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
ParticipantsBG00035
ParticipantsBG00135
ParticipantsBG00236
ParticipantsBG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
ParticipantsBG00035
ParticipantsBG00135
ParticipantsBG002
Race and Ethnicity Not Collected
Race and Ethnicity were not collected from any participant.
Count of Participants
Participants
Title
Denominators
Categories
ParticipantsBG0000
ParticipantsBG0010
ParticipantsBG002
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 Area of Neovascularizations (NVs) at End of Core Study (EOCS)
The area of neovascularizations (NV) was assessed by a central reading center via fluorescein angiography (FA) images. The area of NV was calculated as the sum of area of neovascularization of the disc (NVD) and neovascularization elsewhere (NVE) and was recorded in square millimeters. A higher positive change value may indicate a greater formation of new, abnormal blood vessels and thus disease progression. One eye (study eye) contributed to the analysis.
FAS; LOCF. Only patients with both values at baseline and any post-baseline value were included.
Posted
Mean
Standard Deviation
square millimeters
Baseline, EOCS
ID
Title
Description
OG000
Ranibizumab Mono
Interventional Core Phase: One intravitreal injection of ranibizumab 0.5 mg to the study eye monthly until stability regarding morphological parameters is confirmed (ie, no further improvement of morphology or no worsening of morphology for 3 consecutive months)
OG001
PRP Mono
Interventional Core Phase: Panretinal laser photocoagulation (PRP) treatment administered to the study eye in accordance with the modified diabetic retinopathy study (DRS) guidelines for panretinal laser photocoagulation procedures
OG002
Ranibizumab+PRP
Interventional Core Phase: Ranibizumab 0.5 mg as described for the ranibizumab mono arm and PRP treatment as described for the PRP mono arm until stability regarding morphological parameters is confirmed
Units
Counts
Participants
OG00033
OG00133
OG00233
Title
Denominators
Categories
Title
Measurements
OG000-4.6± 11.3
OG001-0.9± 3.9
OG002-1.7± 3.0
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
ANCOVA
0.0344
Least Squares Mean Difference
-2.8
2-Sided
95
-5.4
-0.2
Other
The focus of this PoC study was not on hypothesis testing but on a rough estimation of differences between treatments. The usual p-values are provided as a descriptive tool.
OG000
OG002
Secondary
Change From Baseline in Area of Neovascularizations (NVs) at Month 3
The area of neovascularizations (NV) was assessed by a central reading center via fluorescein angiography (FA) images. The area of NV was calculated as the sum of area of neovascularization of the disc (NVD) and neovascularization elsewhere (NVE) and was recorded in square millimeters. A higher positive change value may indicate a greater formation of new, abnormal blood vessels and thus disease progression. One eye (study eye) contributed to the analysis.
FAS; LOCF. Only patients with both values at baseline and any post-baseline value were included.
Posted
Mean
Standard Deviation
square millimeters
Baseline, Month 3
ID
Title
Description
OG000
Ranibizumab Mono
Interventional Core Phase: One intravitreal injection of ranibizumab 0.5 mg to the study eye monthly until stability regarding morphological parameters is confirmed (ie, no further improvement of morphology or no worsening of morphology for 3 consecutive months)
OG001
PRP Mono
Interventional Core Phase: Panretinal laser photocoagulation (PRP) treatment administered to the study eye in accordance with the modified diabetic retinopathy study (DRS) guidelines for panretinal laser photocoagulation procedures
OG002
Ranibizumab+PRP
Secondary
Best Corrected Visual Acuity (BCVA) (ETDRS Letters) at EOCS
BCVA was assessed using Early Treatment Diabetic Retinopathy Study (ETDRS)-like charts at a testing distance of 4 meters. A higher number of ETDRS letters may indicate better visual acuity. One eye (study eye) contributed to the analysis.
FAS; LOCF
Posted
Mean
Standard Deviation
letters
EOCS
ID
Title
Description
OG000
Ranibizumab Mono
Interventional Core Phase: One intravitreal injection of ranibizumab 0.5 mg to the study eye monthly until stability regarding morphological parameters is confirmed (ie, no further improvement of morphology or no worsening of morphology for 3 consecutive months)
OG001
PRP Mono
Interventional Core Phase: Panretinal laser photocoagulation (PRP) treatment administered to the study eye in accordance with the modified diabetic retinopathy study (DRS) guidelines for panretinal laser photocoagulation procedures
OG002
Ranibizumab+PRP
Interventional Core Phase: Ranibizumab 0.5 mg as described for the ranibizumab mono arm and PRP treatment as described for the PRP mono arm until stability regarding morphological parameters is confirmed
Secondary
Percentage of Patients With Change From Baseline in BCVA (ETDRS Letters) at EOCS
BCVA was assessed using Early Treatment Diabetic Retinopathy Study (ETDRS)-like charts at a testing distance of 4 meters. No clinically relevant change was defined as <5 letters gain or loss. A higher positive change value may indicate a greater improvement in visual acuity. One eye (study eye) contributed to the analysis.
FAS; LOCF
Posted
Number
percentage of participants
Baseline, EOCS
ID
Title
Description
OG000
Ranibizumab Mono
Interventional Core Phase: One intravitreal injection of ranibizumab 0.5 mg to the study eye monthly until stability regarding morphological parameters is confirmed (ie, no further improvement of morphology or no worsening of morphology for 3 consecutive months)
OG001
PRP Mono
Interventional Core Phase: Panretinal laser photocoagulation (PRP) treatment administered to the study eye in accordance with the modified diabetic retinopathy study (DRS) guidelines for panretinal laser photocoagulation procedures
OG002
Ranibizumab+PRP
Interventional Core Phase: Ranibizumab 0.5 mg as described for the ranibizumab mono arm and PRP treatment as described for the PRP mono arm until stability regarding morphological parameters is confirmed
Secondary
Number of Patients With Change From Baseline in ETDRS Severity Grade of Diabetic Retinopathy (DR) at EOCS
The severity level of diabetic retinopathy was determined using the ETDRS severity scale. However, in contrast to the original ETDRS severity scale, wide field fluorescein angiography images were used in addition to color fundus photography for identification of NVs and prior PRP treatment was not considered for determining the severity level. Eyes could be graded in the following classes: "DR absent" (10), "questionable DR" (14,15), "NPDR" (20-53), "mild PDR" (60-61), "moderate PDR" (65), "high risk PDR" (71-75), "advanced PDR" (81-85) and "cannot grade" (90). One eye (study eye) contributed to the analysis. No statistical analysis was conducted for ≥ 1 class deterioration or ≥ 2 class deterioration from Baseline at EOCS because ratios could not be calculated in case of zero frequencies in at least one of the three treatment groups.
FAS. Only patients with both values at baseline and any post-baseline value were included.
Posted
Number
participants
Baseline, EOCS
ID
Title
Description
OG000
Ranibizumab Mono
Interventional Core Phase: One intravitreal injection of ranibizumab 0.5 mg to the study eye monthly until stability regarding morphological parameters is confirmed (ie, no further improvement of morphology or no worsening of morphology for 3 consecutive months)
OG001
PRP Mono
Interventional Core Phase: Panretinal laser photocoagulation (PRP) treatment administered to the study eye in accordance with the modified diabetic retinopathy study (DRS) guidelines for panretinal laser photocoagulation procedures
Secondary
Change From Baseline in Central Subfield Thickness at EOCS
Central subfield retinal thickness was assessed by a central reading center using Optical Coherence Tomography images. A positive change value may indicate disease progression. One eye (study eye) contributed to the analysis.
FAS; LOCF. Only patients with both values at baseline and any post-baseline value were included.
Posted
Mean
Standard Deviation
micrometer
Baseline, EOCS
ID
Title
Description
OG000
Ranibizumab Mono
Interventional Core Phase: One intravitreal injection of ranibizumab 0.5 mg to the study eye monthly until stability regarding morphological parameters is confirmed (ie, no further improvement of morphology or no worsening of morphology for 3 consecutive months)
OG001
PRP Mono
Interventional Core Phase: Panretinal laser photocoagulation (PRP) treatment administered to the study eye in accordance with the modified diabetic retinopathy study (DRS) guidelines for panretinal laser photocoagulation procedures
OG002
Ranibizumab+PRP
Interventional Core Phase: Ranibizumab 0.5 mg as described for the ranibizumab mono arm and PRP treatment as described for the PRP mono arm until stability regarding morphological parameters is confirmed
Secondary
Change From Baseline in Foveal Center Point Retinal Thickness at EOCS
Foveal center point retinal thickness was assessed by a central reading center using Optical Coherence Tomography images. A positive change value may indicate disease progression. One eye (study eye) contributed to the analysis.
FAS; LOCF. Only patients with both values at baseline and any post-baseline value were included.
Posted
Mean
Standard Deviation
micrometer
Baseline, EOCS
ID
Title
Description
OG000
Ranibizumab Mono
Interventional Core Phase: One intravitreal injection of ranibizumab 0.5 mg to the study eye monthly until stability regarding morphological parameters is confirmed (ie, no further improvement of morphology or no worsening of morphology for 3 consecutive months)
OG001
PRP Mono
Interventional Core Phase: Panretinal laser photocoagulation (PRP) treatment administered to the study eye in accordance with the modified diabetic retinopathy study (DRS) guidelines for panretinal laser photocoagulation procedures
OG002
Ranibizumab+PRP
Interventional Core Phase: Ranibizumab 0.5 mg as described for the ranibizumab mono arm and PRP treatment as described for the PRP mono arm until stability regarding morphological parameters is confirmed
Secondary
Number of Ranibizumab Injections Until EOCS
The total number of ranibizumab injections until EOCS was calculated. One eye (study eye) contributed to the analysis. No statistical analysis was conducted.
Safety Set. This outcome measure was pre-specified for the ranibizumab mono and ranibizumab+PRP arms only.
Posted
Mean
Standard Deviation
injections
Baseline to EOCS
ID
Title
Description
OG000
Ranibizumab Mono
Interventional Core Phase: One intravitreal injection of ranibizumab 0.5 mg to the study eye monthly until stability regarding morphological parameters is confirmed (ie, no further improvement of morphology or no worsening of morphology for 3 consecutive months)
OG001
PRP Mono
Interventional Core Phase: Panretinal laser photocoagulation (PRP) treatment administered to the study eye in accordance with the modified diabetic retinopathy study (DRS) guidelines for panretinal laser photocoagulation procedures
OG002
Ranibizumab+PRP
Interventional Core Phase: Ranibizumab 0.5 mg as described for the ranibizumab mono arm and PRP treatment as described for the PRP mono arm until stability regarding morphological parameters is confirmed
Secondary
Number of PRP Laser Spots Until EOCS
The total number of PRP laser spots from baseline until EOCS was calculated. One eye (study eye) contributed to the analysis. No statistical analysis was conducted.
Safety Set. Only patients with at least 1 laser therapy until EOCS are included in the analysis. This outcome measure was pre-specified for the PRP and the ranibizumab+PRP arms only.
Posted
Mean
Standard Deviation
PRP laser spots
Baseline to EOCS
ID
Title
Description
OG000
Ranibizumab Mono
Interventional Core Phase: One intravitreal injection of ranibizumab 0.5 mg to the study eye monthly until stability regarding morphological parameters is confirmed (ie, no further improvement of morphology or no worsening of morphology for 3 consecutive months)
OG001
PRP Mono
Interventional Core Phase: Panretinal laser photocoagulation (PRP) treatment administered to the study eye in accordance with the modified diabetic retinopathy study (DRS) guidelines for panretinal laser photocoagulation procedures
OG002
Ranibizumab+PRP
Interventional Core Phase: Ranibizumab 0.5 mg as described for the ranibizumab mono arm and PRP treatment as described for the PRP mono arm until stability regarding morphological parameters is confirmed
Time Frame
Adverse Events (AEs) were collected from time of informed consent until 4 weeks after the patient has stopped study participation (approximately 2 years).
Description
The Safety Set consisted of all randomized patients with at least one post-baseline safety assessment.
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
Ranibizumab Mono Until Month 12
All visits up to Month 12 (which could lie after EOCS for patients who discontinued the core phase of the study)
1
35
8
35
34
35
EG001
PRP Mono Until Month 12
All visits up to Month 12 (which could lie after EOCS for patients who discontinued the core phase of the study)
1
35
11
35
29
35
EG002
Ranibizumab+PRP Until Month 12
All visits up to Month 12 (which could lie after EOCS for patients who discontinued the core phase of the study)
2
36
16
36
34
36
EG003
Ranibizumab Mono Month 12 to 24
Non-interventional follow up phase
0
28
5
28
21
28
EG004
PRP Mono Month 12 to 24
Non-interventional follow up phase
0
20
5
20
12
20
EG005
Ranibizumab+PRP Month 12 to 24
Non-interventional follow up phase
0
25
11
25
21
25
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
ACUTE MYOCARDIAL INFARCTION (Non-ocular)
Cardiac disorders
MedDRA (19.1)
Systematic Assessment
EG0001 affected35 at risk
EG0010 affected35 at risk
EG0020 affected36 at risk
EG0030 affected28 at risk
EG004
ATRIAL FIBRILLATION (Non-ocular)
Cardiac disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected35 at risk
EG0011 affected35 at risk
EG0020 affected36 at risk
EG003
CONGESTIVE CARDIOMYOPATHY (Non-ocular)
Cardiac disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected35 at risk
EG0010 affected35 at risk
EG0020 affected36 at risk
EG003
CORONARY ARTERY DISEASE (Non-ocular)
Cardiac disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected35 at risk
EG0010 affected35 at risk
EG0021 affected36 at risk
EG003
HEART VALVE STENOSIS (Non-ocular)
Cardiac disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected35 at risk
EG0010 affected35 at risk
EG0020 affected36 at risk
EG003
SUDDEN HEARING LOSS (Non-ocular)
Ear and labyrinth disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected35 at risk
EG0011 affected35 at risk
EG0020 affected36 at risk
EG003
ANTERIOR CHAMBER DISORDER (Right eye)
Eye disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected35 at risk
EG0010 affected35 at risk
EG0020 affected36 at risk
EG003
CATARACT (Left eye)
Eye disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected35 at risk
EG0010 affected35 at risk
EG0021 affected36 at risk
EG003
CATARACT (Right eye)
Eye disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected35 at risk
EG0011 affected35 at risk
EG0020 affected36 at risk
EG003
DIABETIC RETINAL OEDEMA (Left eye)
Eye disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected35 at risk
EG0010 affected35 at risk
EG0021 affected36 at risk
EG003
DIABETIC RETINAL OEDEMA (Right eye)
Eye disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected35 at risk
EG0010 affected35 at risk
EG0021 affected36 at risk
EG003
DIABETIC RETINOPATHY (Left eye)
Eye disorders
MedDRA (19.1)
Systematic Assessment
EG0001 affected35 at risk
EG0011 affected35 at risk
EG0020 affected36 at risk
EG003
DIABETIC RETINOPATHY (Right eye)
Eye disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected35 at risk
EG0011 affected35 at risk
EG0022 affected36 at risk
EG003
GLAUCOMA (Right eye)
Eye disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected35 at risk
EG0010 affected35 at risk
EG0020 affected36 at risk
EG003
MACULAR FIBROSIS (Left eye)
Eye disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected35 at risk
EG0010 affected35 at risk
EG0020 affected36 at risk
EG003
MACULAR FIBROSIS (Right eye)
Eye disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected35 at risk
EG0010 affected35 at risk
EG0020 affected36 at risk
EG003
MACULAR OEDEMA (Left eye)
Eye disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected35 at risk
EG0010 affected35 at risk
EG0021 affected36 at risk
EG003
OPEN ANGLE GLAUCOMA (Right eye)
Eye disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected35 at risk
EG0011 affected35 at risk
EG0020 affected36 at risk
EG003
RETINAL DETACHMENT (Left eye)
Eye disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected35 at risk
EG0010 affected35 at risk
EG0021 affected36 at risk
EG003
RETINAL HAEMORRHAGE (Both eyes)
Eye disorders
MedDRA (19.1)
Systematic Assessment
EG0001 affected35 at risk
EG0010 affected35 at risk
EG0020 affected36 at risk
EG003
RETINAL HAEMORRHAGE (Right eye)
Eye disorders
MedDRA (19.1)
Systematic Assessment
EG0001 affected35 at risk
EG0010 affected35 at risk
EG0020 affected36 at risk
EG003
RETINAL NEOVASCULARISATION (Right eye)
Eye disorders
MedDRA (19.1)
Systematic Assessment
EG0001 affected35 at risk
EG0010 affected35 at risk
EG0020 affected36 at risk
EG003
VISUAL ACUITY REDUCED (Left eye)
Eye disorders
MedDRA (19.1)
Systematic Assessment
EG0001 affected35 at risk
EG0010 affected35 at risk
EG0020 affected36 at risk
EG003
VITREOUS ADHESIONS (Right eye)
Eye disorders
MedDRA (19.1)
Systematic Assessment
EG0001 affected35 at risk
EG0010 affected35 at risk
EG0020 affected36 at risk
EG003
VITREOUS HAEMORRHAGE (Left eye)
Eye disorders
MedDRA (19.1)
Systematic Assessment
EG0001 affected35 at risk
EG0011 affected35 at risk
EG0021 affected36 at risk
EG003
VITREOUS HAEMORRHAGE (Right eye)
Eye disorders
MedDRA (19.1)
Systematic Assessment
EG0001 affected35 at risk
EG0012 affected35 at risk
EG0020 affected36 at risk
EG003
ABDOMINAL PAIN (Non-ocular)
Gastrointestinal disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected35 at risk
EG0010 affected35 at risk
EG0020 affected36 at risk
EG003
CHRONIC GASTRITIS (Non-ocular)
Gastrointestinal disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected35 at risk
EG0010 affected35 at risk
EG0020 affected36 at risk
EG003
DENTAL CYST (Non-ocular)
Gastrointestinal disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected35 at risk
EG0010 affected35 at risk
EG0020 affected36 at risk
EG003
DIARRHOEA (Non-ocular)
Gastrointestinal disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected35 at risk
EG0010 affected35 at risk
EG0020 affected36 at risk
EG003
UMBILICAL HERNIA (Non-ocular)
Gastrointestinal disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected35 at risk
EG0010 affected35 at risk
EG0020 affected36 at risk
EG003
CHEST PAIN (Non-ocular)
General disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected35 at risk
EG0010 affected35 at risk
EG0020 affected36 at risk
EG003
GENERAL PHYSICAL HEALTH DETERIORATION (Non-ocular)
General disorders
MedDRA (19.1)
Systematic Assessment
EG0001 affected35 at risk
EG0010 affected35 at risk
EG0020 affected36 at risk
EG003
NON-CARDIAC CHEST PAIN (Non-ocular)
General disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected35 at risk
EG0011 affected35 at risk
EG0020 affected36 at risk
EG003
PERIPHERAL SWELLING (Non-ocular)
General disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected35 at risk
EG0010 affected35 at risk
EG0020 affected36 at risk
EG003
GASTROENTERITIS (Non-ocular)
Infections and infestations
MedDRA (19.1)
Systematic Assessment
EG0001 affected35 at risk
EG0010 affected35 at risk
EG0020 affected36 at risk
EG003
INFECTED SKIN ULCER (Non-ocular)
Infections and infestations
MedDRA (19.1)
Systematic Assessment
EG0000 affected35 at risk
EG0010 affected35 at risk
EG0021 affected36 at risk
EG003
LOCALISED INFECTION (Non-ocular)
Infections and infestations
MedDRA (19.1)
Systematic Assessment
EG0000 affected35 at risk
EG0010 affected35 at risk
EG0021 affected36 at risk
EG003
MENINGITIS (Non-ocular)
Infections and infestations
MedDRA (19.1)
Systematic Assessment
EG0000 affected35 at risk
EG0010 affected35 at risk
EG0020 affected36 at risk
EG003
OSTEOMYELITIS (Non-ocular)
Infections and infestations
MedDRA (19.1)
Systematic Assessment
EG0001 affected35 at risk
EG0010 affected35 at risk
EG0020 affected36 at risk
EG003
OSTEOMYELITIS CHRONIC (Non-ocular)
Infections and infestations
MedDRA (19.1)
Systematic Assessment
EG0000 affected35 at risk
EG0010 affected35 at risk
EG0020 affected36 at risk
EG003
POSTOPERATIVE WOUND INFECTION (Non-ocular)
Infections and infestations
MedDRA (19.1)
Systematic Assessment
EG0001 affected35 at risk
EG0010 affected35 at risk
EG0020 affected36 at risk
EG003
FRACTURED COCCYX (Non-ocular)
Injury, poisoning and procedural complications
MedDRA (19.1)
Systematic Assessment
EG0000 affected35 at risk
EG0010 affected35 at risk
EG0020 affected36 at risk
EG003
HUMERUS FRACTURE (Non-ocular)
Injury, poisoning and procedural complications
MedDRA (19.1)
Systematic Assessment
EG0001 affected35 at risk
EG0010 affected35 at risk
EG0020 affected36 at risk
EG003
HYPHAEMA (Right eye)
Injury, poisoning and procedural complications
MedDRA (19.1)
Systematic Assessment
EG0000 affected35 at risk
EG0010 affected35 at risk
EG0020 affected36 at risk
EG003
KIDNEY CONTUSION (Non-ocular)
Injury, poisoning and procedural complications
MedDRA (19.1)
Systematic Assessment
EG0000 affected35 at risk
EG0010 affected35 at risk
EG0021 affected36 at risk
EG003
MENISCUS INJURY (Non-ocular)
Injury, poisoning and procedural complications
MedDRA (19.1)
Systematic Assessment
EG0000 affected35 at risk
EG0010 affected35 at risk
EG0020 affected36 at risk
EG003
RIB FRACTURE (Non-ocular)
Injury, poisoning and procedural complications
MedDRA (19.1)
Systematic Assessment
EG0000 affected35 at risk
EG0010 affected35 at risk
EG0021 affected36 at risk
EG003
SPINAL FRACTURE (Non-ocular)
Injury, poisoning and procedural complications
MedDRA (19.1)
Systematic Assessment
EG0000 affected35 at risk
EG0011 affected35 at risk
EG0020 affected36 at risk
EG003
TENDON RUPTURE (Non-ocular)
Injury, poisoning and procedural complications
MedDRA (19.1)
Systematic Assessment
EG0000 affected35 at risk
EG0010 affected35 at risk
EG0020 affected36 at risk
EG003
BLOOD GLUCOSE FLUCTUATION (Non-ocular)
Investigations
MedDRA (19.1)
Systematic Assessment
EG0000 affected35 at risk
EG0010 affected35 at risk
EG0021 affected36 at risk
EG003
DEHYDRATION (Non-ocular)
Metabolism and nutrition disorders
MedDRA (19.1)
Systematic Assessment
EG0001 affected35 at risk
EG0010 affected35 at risk
EG0020 affected36 at risk
EG003
DIABETES MELLITUS (Non-ocular)
Metabolism and nutrition disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected35 at risk
EG0010 affected35 at risk
EG0021 affected36 at risk
EG003
HYPERGLYCAEMIA (Non-ocular)
Metabolism and nutrition disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected35 at risk
EG0010 affected35 at risk
EG0021 affected36 at risk
EG003
HYPOGLYCAEMIA (Non-ocular)
Metabolism and nutrition disorders
MedDRA (19.1)
Systematic Assessment
EG0001 affected35 at risk
EG0010 affected35 at risk
EG0020 affected36 at risk
EG003
OBESITY (Non-ocular)
Metabolism and nutrition disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected35 at risk
EG0010 affected35 at risk
EG0021 affected36 at risk
EG003
INTERVERTEBRAL DISC PROTRUSION (Non-ocular)
Musculoskeletal and connective tissue disorders
MedDRA (19.1)
Systematic Assessment
EG0001 affected35 at risk
EG0010 affected35 at risk
EG0020 affected36 at risk
EG003
OSTEITIS (Non-ocular)
Musculoskeletal and connective tissue disorders
MedDRA (19.1)
Systematic Assessment
EG0000 affected35 at risk
EG0010 affected35 at risk
EG0021 affected36 at risk
EG003
CHRONIC LYMPHOCYTIC LEUKAEMIA (Non-ocular)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (19.1)
Systematic Assessment
EG0001 affected35 at risk
EG0010 affected35 at risk
EG0020 affected36 at risk
EG003
GASTRIC CANCER (Non-ocular)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.
Point of Contact
Title
Organization
Phone
Extension
Email
Study Director
Novartis Pharmaceuticals
1-862-778-8300
Novartis.email@novartis.com
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
FG0010 subjects
FG0021 subjects
Subject Withdrew Consent
FG0001 subjects
FG0010 subjects
FG0021 subjects
106
Title
Measurements
BG00052.5± 11.0
BG00153.0± 12.1
BG00255.0± 13.4
BG00353.5± 12.1
36
ParticipantsBG003106
Title
Measurements
Female
BG00014
BG00111
BG0028
BG00333
Male
BG00021
BG00124
BG00228
BG00373
0
ParticipantsBG0030
Title
Measurements
BG0030
ANCOVA
0.3809
Least Squares Mean Difference
-1.2
2-Sided
95
-3.8
1.5
Other
The focus of this PoC study was not on hypothesis testing but on a rough estimation of differences between treatments. The usual p-values are provided as a descriptive tool.
OG001
OG002
ANCOVA
0.2113
Least Squares Mean Difference
1.7
2-Sided
95
-1.0
4.3
Other
The focus of this PoC study was not on hypothesis testing but on a rough estimation of differences between treatments. The usual p-values are provided as a descriptive tool.
Interventional Core Phase: Ranibizumab 0.5 mg as described for the ranibizumab mono arm and PRP treatment as described for the PRP mono arm until stability regarding morphological parameters is confirmed
Units
Counts
Participants
OG00033
OG00132
OG00233
Title
Denominators
Categories
Title
Measurements
OG000-5.9± 12.7
OG001-0.7± 2.8
OG002-2.7± 3.9
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
ANCOVA
0.0081
Least Squares Mean Difference
-2.4
2-Sided
95
-4.2
-0.6
Other
The focus of this PoC study was not on hypothesis testing but on a rough estimation of differences between treatments. The usual p-values are provided as a descriptive tool.
OG000
OG002
ANCOVA
0.7494
Least Squares Mean Difference
-0.3
2-Sided
95
-2.0
1.5
Other
The focus of this PoC study was not on hypothesis testing but on a rough estimation of differences between treatments. The usual p-values are provided as a descriptive tool.
OG001
OG002
ANCOVA
0.0175
Least Squares Mean Difference
2.1
2-Sided
95
0.4
3.9
Other
The focus of this PoC study was not on hypothesis testing but on a rough estimation of differences between treatments. The usual p-values are provided as a descriptive tool.
Units
Counts
Participants
OG00035
OG00135
OG00236
Title
Denominators
Categories
Title
Measurements
OG00084.4± 8.6
OG00176.8± 17.0
OG00278.9± 12.2
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
ANCOVA
0.0495
Least Squares Mean Difference
5.5
2-Sided
95
0.0
11.0
Other
The focus of this PoC study was not on hypothesis testing but on a rough estimation of differences between treatments. The usual p-values are provided as a descriptive tool.
OG000
OG002
ANCOVA
0.2767
Least Squares Mean Difference
3.0
2-Sided
95
-2.5
8.5
Other
The focus of this PoC study was not on hypothesis testing but on a rough estimation of differences between treatments. The usual p-values are provided as a descriptive tool.
OG001
OG002
ANCOVA
0.3641
Least Squares Mean Difference
-2.5
2-Sided
95
-7.9
2.9
Other
The focus of this PoC study was not on hypothesis testing but on a rough estimation of differences between treatments. The usual p-values are provided as a descriptive tool.
Units
Counts
Participants
OG00035
OG00135
OG00236
Title
Denominators
Categories
≥15 letters gain from Baseline at EOCS
Title
Measurements
OG0000.0
OG0012.9
OG0020.0
≥10 letters gain from Baseline at EOCS
Title
Measurements
OG0005.7
OG00111.4
OG0028.3
≥5 letters gain from Baseline at EOCS
Title
Measurements
OG00031.4
OG00120.0
OG00213.9
No clinically relevant change from Baseline
Title
Measurements
OG00051.4
OG00142.9
OG00261.1
≥5 letters loss from Baseline at EOCS
Title
Measurements
OG00017.1
OG00137.1
OG00225.0
≥10 letters loss from Baseline at EOCS
Title
Measurements
OG00011.4
OG00111.4
OG0028.3
≥15 letters loss from Baseline at EOCS
Title
Measurements
OG0002.9
OG0018.6
OG0022.8
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
≥10 letters gain
Regression, Logistic
0.4019
Odds Ratio (OR)
0.470
2-Sided
95
0.080
2.749
Other
The focus of this PoC study was not on hypothesis testing but on a rough estimation of differences between treatments. The usual p-values are provided as a descriptive tool.
OG000
OG001
≥5 letters gain
Regression, Logistic
0.2772
Odds Ratio (OR)
1.833
2-Sided
95
0.614
5.471
Other
The focus of this PoC study was not on hypothesis testing but on a rough estimation of differences between treatments. The usual p-values are provided as a descriptive tool.
OG000
OG001
No clinically relevant change
Regression, Logistic
0.4731
Odds Ratio (OR)
1.412
2-Sided
95
0.55
3.622
Other
The focus of this PoC study was not on hypothesis testing but on a rough estimation of differences between treatments. The usual p-values are provided as a descriptive tool.
OG000
OG001
≥5 letters loss
Regression, Logistic
0.065
Odds Ratio (OR)
0.350
2-Sided
95
0.155
1.068
Other
The focus of this PoC study was not on hypothesis testing but on a rough estimation of differences between treatments. The usual p-values are provided as a descriptive tool.
OG000
OG001
≥10 letters loss
Regression, Logistic
1.000
Odds Ratio (OR)
1.000
2-Sided
95
0.229
4.361
Other
The focus of this PoC study was not on hypothesis testing but on a rough estimation of differences between treatments. The usual p-values are provided as a descriptive tool.
OG000
OG001
≥15 letters loss
Regression, Logistic
0.3261
Odds Ratio (OR)
0.314
2-Sided
95
0.031
3.173
Other
The focus of this PoC study was not on hypothesis testing but on a rough estimation of differences between treatments. The usual p-values are provided as a descriptive tool.
OG000
OG002
≥10 letters gain
Regression, Logistic
0.6680
Odds Ratio (OR)
0.667
2-Sided
95
0.104
4.253
Other
The focus of this PoC study was not on hypothesis testing but on a rough estimation of differences between treatments. The usual p-values are provided as a descriptive tool.
OG000
OG002
≥5 letters gain
Regression, Logistic
0.0838
Odds Ratio (OR)
2.842
2-Sided
95
0.870
9.283
Other
The focus of this PoC study was not on hypothesis testing but on a rough estimation of differences between treatments. The usual p-values are provided as a descriptive tool.
OG000
OG002
No clinically relevant change
Regression, Logistic
0.4116
Odds Ratio (OR)
0.674
2-Sided
95
0.263
1.729
Other
The focus of this PoC study was not on hypothesis testing but on a rough estimation of differences between treatments. The usual p-values are provided as a descriptive tool.
OG000
OG002
≥5 letters loss
Regression, Logistic
0.4197
Odds Ratio (OR)
0.621
2-Sided
95
0.195
1.977
Other
The focus of this PoC study was not on hypothesis testing but on a rough estimation of differences between treatments. The usual p-values are provided as a descriptive tool.
OG000
OG002
≥10 letters loss
Regression, Logistic
0.6632
Odds Ratio (OR)
1.419
2-Sided
95
0.294
6.856
Other
The focus of this PoC study was not on hypothesis testing but on a rough estimation of differences between treatments. The usual p-values are provided as a descriptive tool.
OG000
OG002
≥15 letters loss
Regression, Logistic
0.9839
Odds Ratio (OR)
1.029
2-Sided
95
0.062
17.127
Other
The focus of this PoC study was not on hypothesis testing but on a rough estimation of differences between treatments. The usual p-values are provided as a descriptive tool.
OG001
OG002
≥10 letters gain
Regression, Logistic
0.6630
Odds Ratio (OR)
1.419
2-Sided
95
0.294
6.858
Other
The focus of this PoC study was not on hypothesis testing but on a rough estimation of differences between treatments. The usual p-values are provided as a descriptive tool.
OG001
OG002
≥5 letters gain
Regression, Logistic
0.4941
P-value was calculated as a point estimate.
Odds Ratio (OR)
1.550
2-Sided
95
0.441
5.444
Other
The focus of this PoC study was not on hypothesis testing but on a rough estimation of differences between treatments. The usual p-values are provided as a descriptive tool.
OG001
OG002
No clinically relevant change
Regression, Logistic
0.1259
Odds Ratio (OR)
0.477
2-Sided
95
0.185
1.231
Other
The focus of this PoC study was not on hypothesis testing but on a rough estimation of differences between treatments. The usual p-values are provided as a descriptive tool.
OG001
OG002
≥5 letters loss
Regression, Logistic
0.2710
Odds Ratio (OR)
1.773
2-Sided
95
0.640
4.913
Other
The focus of this PoC study was not on hypothesis testing but on a rough estimation of differences between treatments. The usual p-values are provided as a descriptive tool.
OG001
OG002
≥10 letters loss
Regression, Logistic
0.6632
Odds Ratio (OR)
1.419
2-Sided
95
0.294
6.856
Other
The focus of this PoC study was not on hypothesis testing but on a rough estimation of differences between treatments. The usual p-values are provided as a descriptive tool.
OG001
OG002
≥15 letters loss
Regression, Logistic
0.3140
Odds Ratio (OR)
3.282
2-Sided
95
0.325
33.171
Other
The focus of this PoC study was not on hypothesis testing but on a rough estimation of differences between treatments. The usual p-values are provided as a descriptive tool.
OG002
Ranibizumab+PRP
Interventional Core Phase: Ranibizumab 0.5 mg as described for the ranibizumab mono arm and PRP treatment as described for the PRP mono arm until stability regarding morphological parameters is confirmed
Units
Counts
Participants
OG00029
OG00126
OG00228
Title
Denominators
Categories
≥ 1 class improvement from Baseline at EOCS
Title
Measurements
OG00010
OG0019
OG00213
≥ 2 class improvement from Baseline at EOCS
Title
Measurements
OG0002
OG0012
OG0025
≥ 1 class deterioration from Baseline at EOCS
Title
Measurements
OG0002
OG0010
OG0021
≥ 2 class deterioration from Baseline at EOCS
Title
Measurements
OG0000
OG0010
OG0020
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
≥ 1 class improvement from Baseline at EOCS
Regression, Logistic
0.9918
Odds Ratio (OR)
0.994
2-Sided
95
0.327
3.026
Other
The focus of this PoC study was not on hypothesis testing but on a rough estimation of differences between treatments. The usual p-values are provided as a descriptive tool.
OG000
OG002
≥ 1 class improvement from Baseline at EOCS
Regression, Logistic
0.3595
Odds Ratio (OR)
0.607
2-Sided
95
0.209
1.765
Other
The focus of this PoC study was not on hypothesis testing but on a rough estimation of differences between treatments. The usual p-values are provided as a descriptive tool.
OG001
OG002
≥ 1 class improvement from Baseline at EOCS
Regression, Logistic
0.3787
Odds Ratio (OR)
0.611
2-Sided
95
0.204
1.830
Other
The focus of this PoC study was not on hypothesis testing but on a rough estimation of differences between treatments. The usual p-values are provided as a descriptive tool.
OG000
OG001
≥ 2 class improvement from Baseline at EOCS
Regression, Logistic
0.9097
Odds Ratio (OR)
0.889
2-Sided
95
0.116
6.806
Other
The focus of this PoC study was not on hypothesis testing but on a rough estimation of differences between treatments. The usual p-values are provided as a descriptive tool.
OG000
OG002
≥ 2 class improvement from Baseline at EOCS
Regression, Logistic
0.2230
Odds Ratio (OR)
0.341
2-Sided
95
0.060
1.925
Other
The focus of this PoC study was not on hypothesis testing but on a rough estimation of differences between treatments. The usual p-values are provided as a descriptive tool.
OG001
OG002
≥ 2 class improvement from Baseline at EOCS
Regression, Logistic
0.2792
Odds Ratio (OR)
0.383
2-Sided
95
0.068
2.177
Other
The focus of this PoC study was not on hypothesis testing but on a rough estimation of differences between treatments. The usual p-values are provided as a descriptive tool.
Units
Counts
Participants
OG00032
OG00131
OG00231
Title
Denominators
Categories
Title
Measurements
OG000-6.0± 15.1
OG00136.2± 55.9
OG00217.6± 46.7
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
ANCOVA
0.0003
Least Squares Mean Difference
-40.7
2-Sided
95
-62.1
-19.3
Other
The focus of this PoC study was not on hypothesis testing but on a rough estimation of differences between treatments. The usual p-values are provided as a descriptive tool.
OG000
OG002
ANCOVA
0.0357
Least Squares Mean Difference
-22.9
2-Sided
95
-44.2
-1.6
Other
The focus of this PoC study was not on hypothesis testing but on a rough estimation of differences between treatments. The usual p-values are provided as a descriptive tool.
OG001
OG002
ANCOVA
0.1034
Least Squares Mean Difference
17.8
2-Sided
95
-3.7
39.3
Other
The focus of this PoC study was not on hypothesis testing but on a rough estimation of differences between treatments. The usual p-values are provided as a descriptive tool.
Units
Counts
Participants
OG00032
OG00131
OG00231
Title
Denominators
Categories
Title
Measurements
OG000-4.7± 21.2
OG00148.1± 83.7
OG00225.5± 53.5
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
ANCOVA
0.0007
Least Squares Mean Difference
-51.7
2-Sided
95
-81.1
-22.3
Other
The focus of this PoC study was not on hypothesis testing but on a rough estimation of differences between treatments. The usual p-values are provided as a descriptive tool.
OG000
OG002
ANCOVA
0.0542
Least Squares Mean Difference
-28.9
2-Sided
95
-58.4
0.5
Other
The focus of this PoC study was not on hypothesis testing but on a rough estimation of differences between treatments. The usual p-values are provided as a descriptive tool.
OG001
OG002
ANCOVA
0.1288
Least Squares Mean Difference
22.8
2-Sided
95
-6.7
52.3
Other
The focus of this PoC study was not on hypothesis testing but on a rough estimation of differences between treatments. The usual p-values are provided as a descriptive tool.
Units
Counts
Participants
OG00035
OG00135
OG00236
Title
Denominators
Categories
Title
Measurements
OG0005.2± 2.3
OG001NA± NAThis outcome measure was pre-specified for the ranibizumab mono and ranibizumab+PRP arms only.
OG0025.0± 2.2
Units
Counts
Participants
OG00035
OG00135
OG00236
Title
Denominators
Categories
Title
Measurements
OG000NA± NAThis outcome measure was pre-specified for the PRP and the ranibizumab+PRP arms only.