Laser-Ranibizumab-Triamcinolone for Diabetic Macular Edema
Official Title
Intravitreal Ranibizumab or Triamcinolone Acetonide in Combination With Laser Photocoagulation for Diabetic Macular Edema
Acronym
LRT for DME
Organization
Jaeb Center for Health ResearchOTHER
Status Module
Record Verification Date
Sep 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
Mar 2007
Primary Completion Date
Dec 2009Actual
Completion Date
Feb 2014Actual
First Submitted Date
Mar 6, 2007
First Submission Date that Met QC Criteria
Mar 6, 2007
First Posted Date
Mar 8, 2007Estimated
Results Waived
Not provided
Results First Submitted Date
Jan 14, 2011
Results First Submitted that Met QC Criteria
Jun 14, 2011
Results First Posted Date
Jul 12, 2011Estimated
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
Sep 20, 2019
Last Update Posted Date
Oct 7, 2019Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Jaeb Center for Health ResearchOTHER
Collaborators
Name
Class
National Eye Institute (NEI)
NIH
Allergan
INDUSTRY
Genentech, Inc.
INDUSTRY
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The purpose of the study is to find out which is a better treatment for diabetic macular edema (DME): laser alone, laser combined with an intravitreal injection of triamcinolone, laser combined with an intravitreal injection of ranibizumab, or intravitreal injection of ranibizumab alone. At the present time, it is not known whether intravitreal steroid or anti-vascular endothelial growth factor (anti-VEGF) injections, with or without laser treatment, are better than just laser by itself. It is possible that one or both of the types of injections, with or without laser treatment, will improve vision more often than will laser without injections. However, even if better vision outcomes are seen with injections, side effects may be more of a problem with the injections than with laser. Therefore, this study is conducted to find out whether the benefits of the injections will outweigh the risks.
Detailed Description
Thus far the only demonstrated means to reduce the risk of vision loss from diabetic macular edema are laser photocoagulation, intensive glycemic control, and blood pressure control. Earlier studies have shown that photocoagulation, although effective in reducing the risk of moderate vision loss, can eventually result in retinal and retinal pigment epithelium atrophy resulting in loss of central vision, central scotomata, and decreased color vision. Consequently, many retinal specialists today tend to treat diabetic macular edema (DME) with lighter, less intense laser burns than was originally specified in the Early Treatment Diabetic Retinopathy Study (ETDRS). The additional unsatisfactory outcome from treatments with laser photocoagulation in a significant proportion of eyes with DME has prompted interest in other treatment modalities. One such treatment is pars plana vitrectomy. Studies suggest that vitreomacular traction may play a role in increased retinal vascular permeability, and that removal of the vitreous, or relief of mechanical traction with vitrectomy and membrane stripping may substantially improve macular edema and visual acuity. However, this treatment may be applicable only to a specific subset of eyes with a component of vitreomacular traction secondary to edema. Other treatment modalities such as pharmacologic therapy with oral protein kinase C inhibitors and intravitreal corticosteroids are under investigation.
The use of antibodies targeted at vascular endothelial growth factor (VEGF) is another treatment modality that needs to be further explored for its potential benefits. Increased VEGF levels have been demonstrated in the retina and vitreous of human eyes with diabetic retinopathy. VEGF, also knows as vascular permeability factor, has been shown to increase retinal vascular permeability in in vivo models. Therapy that inhibits VEGF, therefore, may represent a useful therapeutic modality which targets the underlying pathogenesis of diabetic macular edema. Ranibizumab is a promising anti-VEGF drug. Its efficacy and safety have been demonstrated in treatment of age-related macular degeneration. Reports of its use and that of other anti-VEGF drugs in DME have suggested sufficient benefit to warrant evaluation of efficacy and safety in a phase III trial. Corticosteroids, a class of substances with anti-inflammatory properties, have also been demonstrated to inhibit the expression of the VEGF gene. The Diabetic Retinopathy Clinical Research Network (DRCR.net) is currently conducting a phase III randomized clinical trial comparing focal photocoagulation to intravitreal corticosteroids (triamcinolone acetonide) for diabetic macular edema. However, even if triamcinolone or ranibizumab are proven to be efficacious, a major concern, based on clinical observations with intravitreal corticosteroids, is that DME will recur as the effect of the intravitreal drug wears off, necessitating repetitive injections long-term. Combining an intravitreal drug (triamcinolone or ranibizumab) with photocoagulation provides hope that one could get the short-term benefit of the intravitreal drug (decreased retinal thickening and decreased fluid leakage) and the long-term reduction in fluid leakage as a result of photocoagulation. In addition, it is possible that the worsening of macular edema immediately following focal photocoagulation, a known complication of this treatment, could be decreased if an intravitreal drug was present at the time of photocoagulation. This might result in an increased likelihood of vision improvement following photocoagulation and a decreased likelihood of vision loss.
This study is designed to determine if ranibizumab alone or ranibizumab added to laser photocoagulation is more efficacious than photocoagulation alone, and if so, to determine if combining ranibizumab with photocoagulation reduces the total number of injections needed to obtain these benefits. Furthermore, this study is designed to determine if combining photocoagulation with corticosteroids, the only other class of drugs currently being considered for treatment of DME, is efficacious in the population being enrolled.
Subjects will be randomly assigned to one of the following 4 groups:
Group A: Sham injection plus focal (macular) photocoagulation
Group B: 0.5 mg injection of intravitreal ranibizumab plus focal photocoagulation
Group C: 0.5 mg injection of intravitreal ranibizumab plus deferred focal photocoagulation
Group D: 4 mg intravitreal triamcinolone plus focal photocoagulation
In groups A, B and D, laser will be given 7-10 days after the initial injection at the time of the injection follow-up safety visit. During the first year, subjects are evaluated for retreatment every 4 weeks. The injection for group A is a sham and for groups B and C ranibizumab. For group D, a triamcinolone injection is given if one has not been given in the prior 15 weeks; otherwise a sham injection is given. For Groups A, B, and D, focal photocoagulation will be given 7 to 10 days later following each injection unless focal photocoagulation has been given in the past 15 weeks or no macular edema is present. In Years 2 and 3, subjects continue to be evaluated for retreatment every 4 weeks unless injections are discontinued due to failure. In that case, follow-up visits occur every 4 months and treatment is at investigator discretion.
Conditions Module
Conditions
Diabetic Retinopathy
Diabetic Macular Edema
Keywords
Diabetic Retinopathy
Diabetic Macular Edema
Lucentis
Ranibizumab
Triamcinolone
Laser photocoagulation
Combination Therapy
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 3
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
691Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
0.5mg Ranibizumab plus laser
Experimental
Drug: Ranibizumab + laser
0.5 mg Ranibizumab plus deferred laser
Experimental
Drug: Ranibizumab + deferred laser
4 mg Triamcinolone plus laser
Experimental
Drug: Triamcinolone Acetonide + laser
Sham plus laser
Active Comparator
Drug: Sham injection + laser
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Triamcinolone Acetonide + laser
Drug
4 mg intravitreal triamcinolone at randomization plus focal photocoagulation 1 week post-injection, repeated every 16 weeks with sham injections at 4-week intervals in-between. Retreatment starting at 16 weeks depends on visual acuity and OCT.
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Mean Change in Visual Acuity (Letters) From Baseline to 1 Year Adjusted for Baseline Visual Acuity
Change in best correct visual acuity letter score from baseline to one year as measured by a certified tester using an electronic visual acuity testing machine based on the Early Treatment Diabetic Retinopathy Study (ETDRS) method. A positive change denotes an improvement. Best value on the scale 97, worst 0.
from baseline to 1 Year
Distribution of Change in Visual Acuity (Letters) From Baseline to 1 Year
Change in best correct visual acuity letter score as measured by a certified tester using an electronic visual acuity testing machine based on the Early Treatment Diabetic Retinopathy Study (ETDRS) method.
from baseline to 1 Year
Change in Visual Acuity From Baseline to 1 Year Among Eyes That Were Pseudophakic at Baseline
from baseline to 1 Year
Change in Visual Acuity From Baseline to 1 Year Among Eyes That Had Prior Treatment for Diabetic Macular Edema
from baseline to 1 Year
Change in Visual Acuity From Baseline to 1 Year Grouped by Baseline Visual Acuity Letter Score
Change in best correct visual acuity letter score as measured by a certified tester using an electronic visual acuity testing machine based on the Early Treatment Diabetic Retinopathy Study (ETDRS) method. A positive change denotes an improvement. Best value on the scale 97, worst 0.
from baseline to 1 Year
Change in Visual Acuity From Baseline to 1 Year Grouped by Optical Coherence Tomography Central Subfield Thickness
Change in best correct visual acuity letter score from baseline to one year as measured by a certified tester using an electronic visual acuity testing machine based on the Early Treatment Diabetic Retinopathy Study (ETDRS) method. A positive change denotes an improvement. Best value on the scale 97, worst 0.
Secondary Outcomes
Measure
Description
Time Frame
Change in Retinal Thickening of Central Subfield on Optical Coherence Tomography From Baseline to 1 Year
Negative change denotes an improvement.
from baseline to 1 year
Number of Injections in First Year
Other Outcomes
Measure
Description
Time Frame
Central Subfield Thickness < 250 With at Least a 25 Micron Decrease From Baseline to 1 Year
1 Year
Distribution of Logarithmic Transformation of Optical Coherence Tomography (LogOCT) Improvement and Worsening
Logarithmic transformation of optical coherence tomography central subfield thickness is calculated by taking the log base 10 of the ratio of the central subfield thickness divided by 200 and rounding to the nearest hundredth. The change is the change in the log values.
Eligibility Module
Eligibility Criteria
General Inclusion Criteria
To be eligible, the following inclusion criteria (1-5) must be met:
Age >= 18 years
Diagnosis of diabetes mellitus (type 1 or type 2)
At least one eye meets the study eye criteria
Fellow eye (if not a study eye) meets criteria
Able and willing to provide informed consent
General Exclusion Criteria
A subject is not eligible if any of the following exclusion criteria are present:
Significant renal disease, defined as a history of chronic renal failure requiring dialysis or kidney transplant.
A condition that, in the opinion of the investigator, would preclude participation in the study (e.g., unstable medical status including blood pressure, cardiovascular disease, and glycemic control).
Participation in an investigational trial within 30 days of randomization that involved treatment with any drug that has not received regulatory approval at the time of study entry.
Major surgery within 28 days prior to randomization or major surgery planned during the next 6 months.
Myocardial infarction, other cardiac event requiring hospitalization, stroke, transient ischemic attack, or treatment for acute congestive heart failure within 4 months prior to randomization.
Systemic anti-vascular growth factor (anti-VEGF) or pro-VEGF treatment within 4 months prior to randomization.
For women of child-bearing potential: pregnant or lactating or intending to become pregnant within the next 12 months.
Subject is expecting to move out of the area of the clinical center to an area not covered by another clinical center during the first 12 months of the study.
Study Eye Inclusion Criteria
The subject must have one eye meeting all of the inclusion criteria and none of the exclusion criteria listed below. A subject may have two study eyes only if both are eligible at the time of randomization.
Best corrected electronic Early Treatment Diabetic Retinopathy (E-ETDRS) visual acuity letter score <= 78 (i.e., 20/32 or worse) and >= 24 (i.e., 20/320 or better) within 8 days of randomization.
On clinical exam, definite retinal thickening due to diabetic macular edema involving the center of the macula.
Ocular coherence tomography (OCT) central subfield >=250 microns within 8 days of randomization.
Media clarity, pupillary dilation, and subject cooperation sufficient for adequate fundus photographs.
If prior macular photocoagulation has been performed, the investigator believes that the study eye may possibly benefit from additional photocoagulation.
Study Eye Exclusion Criteria
The following exclusions apply to the study eye only (i.e., they may be present for the nonstudy eye):
Macular edema is considered to be due to a cause other than diabetic macular edema.
An ocular condition is present such that, in the opinion of the investigator, visual acuity loss would not improve from resolution of macular edema (e.g., foveal atrophy, pigment abnormalities, dense subfoveal hard exudates, nonretinal condition).
An ocular condition is present (other than diabetes) that, in the opinion of the investigator, might affect macular edema or alter visual acuity during the course of the study (e.g., vein occlusion, uveitis or other ocular inflammatory disease, neovascular glaucoma, etc.)
Substantial cataract that, in the opinion of the investigator, is likely to be decreasing visual acuity by 3 lines or more (i.e., cataract would be reducing acuity to 20/40 or worse if eye was otherwise normal).
History of treatment for diabetic macular edema at any time in the past 4 months (such as focal/grid macular photocoagulation, intravitreal or peribulbar corticosteroids, anti-VEGF drugs, or any other treatment).
History of panretinal (scatter) photocoagulation (PRP) within 4 months prior to randomization.
Anticipated need for PRP in the 6 months following randomization.
History of major ocular surgery (including vitrectomy, cataract extraction, scleral buckle, any intraocular surgery, etc.) within prior 4 months or anticipated within the next 6 months following randomization.
History of yttrium aluminum garnet (YAG) capsulotomy performed within 2 months prior to randomization.
Aphakia.
Intraocular pressure >= 25 mmHg.
History of open-angle glaucoma (either primary open-angle glaucoma or other cause of open-angle glaucoma; note: history of angle-closure glaucoma is not an exclusion criterion).
History of steroid-induced intraocular pressure (IOP) elevation that required IOP-lowering treatment.
History of prior herpetic ocular infection.
Exam evidence of ocular toxoplasmosis.
Exam evidence of pseudoexfoliation.
Exam evidence of external ocular infection, including conjunctivitis, chalazion, or significant blepharitis.
Participants with two study eyes enrolled each eye in a different treatment group. Therefore, each treatment group/arm includes no more than one study eye for a given participant, and thus the numbers of eyes is equal to the number of participants in each arm.
Recruitment Details
Fifty two academic and community based sites across the United States recruited 691 study participants from March 2007 to December 2008.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Sham+Prompt Laser
Sham injection at randomization plus focal photocoagulation 1 week post-injection. Injections are repeated every 4 weeks with focal photocoagulation given post-injection every 16 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT.
FG001
0.5 mg Ranibizumab+Prompt Laser
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
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
MeSH Terms
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
Double
Masking Description
Not provided
Who Masked
ParticipantOutcomes Assessor
4 mg Triamcinolone plus laser
corticosteroid
Ranibizumab + laser
Drug
0.5 mg intravitreal ranibizumab at randomization plus focal photocoagulation 1 week post-injection. Injections are repeated every 4 weeks with focal photocoagulation given post-injection every 16 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT.
0.5mg Ranibizumab plus laser
Lucentis, anti-VEGF drug
Sham injection + laser
Drug
Sham injection at randomization plus focal photocoagulation 1 week post-injection. Injections are repeated every 4 weeks with focal photocoagulation given post-injection every 16 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT.
Sham plus laser
placebo
Ranibizumab + deferred laser
Drug
0.5 mg intravitreal ranibizumab at randomization, repeated every 4 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT. If improvement has not occured from injections alone, laser can be given starting at the 24 week visit.
0.5 mg Ranibizumab plus deferred laser
Lucentis, anti-VEGF drug
from baseline to 1 Year
Change in Visual Acuity From Baseline to 1 Year Grouped by Diabetic Retinopathy Severity
Change in best correct visual acuity letter score from baseline to one year as measured by a certified tester using an electronic visual acuity testing machine based on the Early Treatment Diabetic Retinopathy Study (ETDRS) method. A positive change denotes an improvement. Best value on the scale 97, worst 0.
from baseline to 1 Year
Change in Visual Acuity From Baseline to 1 Year Grouped by Diffuse vs. Focal Edema as Characterized by the Investigator
Change in best correct visual acuity letter score from baseline to one year as measured by a certified tester using an electronic visual acuity testing machine based on the Early Treatment Diabetic Retinopathy Study (ETDRS) method. A positive change denotes an improvement. Best value on the scale 97, worst 0.
from baseline to 1 Year
Maximum possible number of injections for each of the following groups: sham+prompt laser=13 sham injections;ranibizumab+prompt laser=13 ranibizumab injections; ranibizumab+deferred laser=13 ranibizumab injections; triamcinolone+prompt laser=4 triamcinolone injections and 9 sham injections.
from baseline to 1 year
Number of Laser Treatments Received Prior to the 1 Year Visit
One eye in the sham+prompt laser group did not receive laser until post 1-year due to an adverse event unrelated to study treatment. One eye in the triamcinolone+prompt laser did not receive laser until after 1-year due to missing 2 consecutive visits at the time of required laser treatment.
1 Year
Percentage of Eyes Receiving Laser at the 48 Week Visit (%)
1 Year
Mean Optical Coherence Tomography Retinal Volume at 1 Year
1 Year
Mean Change in Optical Coherence Tomography Retinal Volume From Baseline to 1 Year
from baseline to 1 Year
1 Year
Eyes With Alternative Treatments Prior to the 1-year Visit
Each combination of treatment only counted once.
1 Year
Change From Moderately Severe Non-proliferative Diabetic Retinopathy or Better From Baseline to 1-year
113 eyes had missing or ungradable photos at 1 year. Criteria are based on the ETDRS fundus photographic risk factors for the progression of diabetic retinopathy. ETDRS report no. 12. Ophthalmology 1991; 98:823-833
from baseline to 1 Year
Change From Severe Non-proliferative Diabetic Retinopathy or Worse From Baseline to 1-year
Criteria are based on the ETDRS fundus photographic risk factors for the progression of diabetic retinopathy. ETDRS report no. 12. Ophthalmology 1991; 98:823-833, ETDRS Severity Scale = Diabetic retinopathy absent, minimal non-proliferative diabetic retinopathy (PDR), mild to moderately severe non-PDR, severe non-PDR, scars of full pr partial panretinal photocoagulation present PDR absent, mild to moderate PDR, high risk PDR, cannot grade, missing.
from baseline to 1 Year
Cardiovascular Events According to Antiplatelet Trialists' Collaboration Through 1 Year
Antiplatelet Trialists' Collaboration is a collaborative overview of randomised trials of antiplatelet therapy - I: Prevention of death, myocardial infarction, and stroke by prolonged antiplatelet therapy in various categories of patients. Antiplatelet Trialists' Collaboration. MBJ 1994; 308:81-106. Nonfatal cerebrovascular accident includes ischemic or hemorrhagic or unknown events. Vascular death includes death from any potential vascular or unknown cause.
1 Year
Major Ocular Adverse Events During First Year of Follow-Up
1 Year
Beverly Hills
California
90211
United States
University of California, Irvine
Irvine
California
92697
United States
Loma Linda University Health Care, Dept. of Ophthalmology
Loma Linda
California
92354
United States
Southern California Desert Retina Consultants, MC
Palm Springs
California
92262
United States
California Retina Consultants
Santa Barbara
California
93103
United States
Bay Area Retina Associates
Walnut Creek
California
94598
United States
Retina Vitreous Consultants
Fort Lauderdale
Florida
33334
United States
Retina Consultants of Southwest Florida
Fort Myers
Florida
33912
United States
University of Florida College of Med., Department of Ophthalmology
Jacksonville
Florida
32209
United States
Central Florida Retina Institute
Lakeland
Florida
33805
United States
Southeast Retina Center, P.C.
Augusta
Georgia
30909
United States
Illinois Retina Associates
Joliet
Illinois
60435
United States
Raj K. Maturi, M.D., P.C.
Indianapolis
Indiana
46280
United States
John-Kenyon American Eye Institute
New Albany
Indiana
47150
United States
Medical Associates Clinic, P.C.
Dubuque
Iowa
52002
United States
Retina and Vitreous Associates of Kentucky
Lexington
Kentucky
40509-1802
United States
Paducah Retinal Center
Paducah
Kentucky
42001
United States
Elman Retina Group, P.A.
Baltimore
Maryland
21237
United States
Wilmer Eye Institute at Johns Hopkins
Baltimore
Maryland
21287-9277
United States
Retina Consultants of Delmarva, P.A.
Salisbury
Maryland
21801
United States
Ophthalmic Consultants of Boston
Boston
Massachusetts
02114
United States
Joslin Diabetes Center
Boston
Massachusetts
02215
United States
Retina Center, PA
Minneapolis
Minnesota
55404
United States
Eyesight Ophthalmic Services, PA
Portsmouth
New Hampshire
03801
United States
The New York Eye and Ear Infirmary/Faculty Eye Practice
New York
New York
10003
United States
Retina-Vitreous Surgeons of Central New York, PC
Syracuse
New York
13224
United States
University of North Carolina, Dept of Ophthalmology
Chapel Hill
North Carolina
27599-7040
United States
Charlotte Eye, Ear, Nose and Throat Assoc., PA
Charlotte
North Carolina
28210
United States
Wake Forest University Eye Center
Winston-Salem
North Carolina
27157
United States
Retina Associates of Cleveland, Inc.
Beachwood
Ohio
44122
United States
Case Western Reserve University
Cleveland
Ohio
44106
United States
Retina Northwest, PC
Portland
Oregon
97210
United States
Casey Eye Institute
Portland
Oregon
97239
United States
Penn State College of Medicine
Hershey
Pennsylvania
17033
United States
University of Pennsylvania Scheie Eye Institute
Philadelphia
Pennsylvania
19104
United States
Retina Consultants
Providence
Rhode Island
02903
United States
Palmetto Retina Center
Columbia
South Carolina
29169
United States
Carolina Retina Center
Columbia
South Carolina
29223
United States
Southeastern Retina Associates, PC
Kingsport
Tennessee
37660
United States
Southeastern Retina Associates, P.C.
Knoxville
Tennessee
37909
United States
West Texas Retina Consultants P.A.
Abilene
Texas
79605
United States
Retina Research Center
Austin
Texas
78705
United States
Texas Retina Associates
Dallas
Texas
75231
United States
Retina and Vitreous of Texas
Houston
Texas
77025
United States
Vitreoretinal Consultants
Houston
Texas
77030
United States
Texas Retina Associates
Lubbock
Texas
79424
United States
University of Washington Medical Center
Seattle
Washington
98195
United States
University of Wisconsin-Madison, Dept of Ophthalmology/Retina Service
Bressler SB, Qin H, Beck RW, Chalam KV, Kim JE, Melia M, Wells JA 3rd; Diabetic Retinopathy Clinical Research Network. Factors associated with changes in visual acuity and central subfield thickness at 1 year after treatment for diabetic macular edema with ranibizumab. Arch Ophthalmol. 2012 Sep;130(9):1153-61. doi: 10.1001/archophthalmol.2012.1107.
Bressler SB, Qin H, Melia M, Bressler NM, Beck RW, Chan CK, Grover S, Miller DG; Diabetic Retinopathy Clinical Research Network. Exploratory analysis of the effect of intravitreal ranibizumab or triamcinolone on worsening of diabetic retinopathy in a randomized clinical trial. JAMA Ophthalmol. 2013 Aug;131(8):1033-40. doi: 10.1001/jamaophthalmol.2013.4154.
Bressler SB, Almukhtar T, Bhorade A, Bressler NM, Glassman AR, Huang SS, Jampol LM, Kim JE, Melia M; Diabetic Retinopathy Clinical Research Network Investigators. Repeated intravitreous ranibizumab injections for diabetic macular edema and the risk of sustained elevation of intraocular pressure or the need for ocular hypotensive treatment. JAMA Ophthalmol. 2015 May;133(5):589-97. doi: 10.1001/jamaophthalmol.2015.186.
Bressler SB, Glassman AR, Almukhtar T, Bressler NM, Ferris FL, Googe JM Jr, Gupta SK, Jampol LM, Melia M, Wells JA 3rd; Diabetic Retinopathy Clinical Research Network. Five-Year Outcomes of Ranibizumab With Prompt or Deferred Laser Versus Laser or Triamcinolone Plus Deferred Ranibizumab for Diabetic Macular Edema. Am J Ophthalmol. 2016 Apr;164:57-68. doi: 10.1016/j.ajo.2015.12.025. Epub 2016 Jan 21.
Talcott KE, Valentim CCS, Hill L, Stoilov I, Singh RP. Baseline Diabetic Retinopathy Severity and Time to Diabetic Macular Edema Resolution with Ranibizumab Treatment: A Meta-Analysis. Ophthalmol Retina. 2023 Jul;7(7):605-611. doi: 10.1016/j.oret.2023.02.003. Epub 2023 Feb 10.
Gangaputra S, Almukhtar T, Glassman AR, Aiello LP, Bressler N, Bressler SB, Danis RP, Davis MD; Diabetic Retinopathy Clinical Research Network. Comparison of film and digital fundus photographs in eyes of individuals with diabetes mellitus. Invest Ophthalmol Vis Sci. 2011 Aug 3;52(9):6168-73. doi: 10.1167/iovs.11-7321.
Bhavsar AR, Googe JM Jr, Stockdale CR, Bressler NM, Brucker AJ, Elman MJ, Glassman AR; Diabetic Retinopathy Clinical Research Network. Risk of endophthalmitis after intravitreal drug injection when topical antibiotics are not required: the diabetic retinopathy clinical research network laser-ranibizumab-triamcinolone clinical trials. Arch Ophthalmol. 2009 Dec;127(12):1581-3. doi: 10.1001/archophthalmol.2009.304.
0.5 mg intravitreal ranibizumab at randomization plus focal photocoagulation 1 week post-injection. Injections are repeated every 4 weeks with focal photocoagulation given post-injection every 16 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT.
FG002
0.5 mg Ranibizumab+Deferred Laser
0.5 mg intravitreal ranibizumab at randomization, repeated every 4 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT. If improvement has not occured from injections alone, laser can be given starting at the 24 week visit.
FG003
4 mg Triamcinolone+Prompt Laser
4 mg intravitreal triamcinolone at randomization plus focal photocoagulation 1 week post-injection, repeated every 16 weeks with sham injections at 4-week intervals in-between. Retreatment starting at 16 weeks depends on visual acuity and OCT.
FG000293 subjectsNumber of eyes
FG001187 subjectsNumber of eyes
FG002188 subjectsNumber of eyes
FG003186 subjectsNumber of eyes
COMPLETED
FG000274 subjectsNumber of eyes
FG001171 subjectsNumber of eyes
FG002178 subjectsNumber of eyes
FG003176 subjectsNumber of eyes
NOT COMPLETED
FG00019 subjects
FG00116 subjects
FG00210 subjects
FG00310 subjects
Type
Comment
Reasons
Death
FG0007 subjects
FG0015 subjects
FG0023 subjects
FG0032 subjects
Dropped
FG00011 subjects
FG00111 subjects
FG0027 subjects
FG0037 subjects
Missed visit
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Sham+Prompt Laser
Sham injection at randomization plus focal photocoagulation 1 week post-injection. Injections are repeated every 4 weeks with focal photocoagulation given post-injection every 16 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT.
BG001
0.5 mg Ranibizumab+Prompt Laser
0.5 mg intravitreal ranibizumab at randomization plus focal photocoagulation 1 week post-injection. Injections are repeated every 4 weeks with focal photocoagulation given post-injection every 16 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT.
BG002
0.5 mg Ranibizumab+Deferred Laser
0.5 mg intravitreal ranibizumab at randomization, repeated every 4 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT. If improvement has not occured from injections alone, laser can be given starting at the 24 week visit.
BG003
4 mg Triamcinolone+Prompt Laser
4 mg intravitreal triamcinolone at randomization plus focal photocoagulation 1 week post-injection, repeated every 16 weeks with sham injections at 4-week intervals in-between. Retreatment starting at 16 weeks depends on visual acuity and OCT.
BG004
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG000293
BG001187
BG002188
BG003186
BG004854
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Median
Inter-Quartile Range
years
Title
Denominators
Categories
Title
Measurements
BG00063(57 to 69)
BG00162(56 to 70)
BG00264(58 to 70)
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG000123
BG00185
BG002
Race/Ethnicity, Customized
Number
Participants
Title
Denominators
Categories
White
Title
Measurements
BG000202
BG001131
BG002
Visual Acuity Letter Score (approximate Snellen equivalent) by randomization strata
Number
Eyes
Title
Denominators
Categories
≥66 (better than 20/50)
Title
Measurements
BG000146
BG00195
BG002
Classification of diabetic macular edema
Based on clinical exam.
Number
Eyes
Title
Denominators
Categories
Predominantly focal
Title
Measurements
BG00078
BG00160
BG002
Number of study eyes
Number
Participants
Title
Denominators
Categories
1 study eye
Title
Measurements
BG000130
BG001131
BG002
Diabetes Type
Number
Participants
Title
Denominators
Categories
Type 1
Title
Measurements
BG00025
BG00111
BG002
Duration of diabetes
Median
Inter-Quartile Range
Years
Title
Denominators
Categories
Title
Measurements
BG00016(9 to 22)
BG00118(12 to 24)
BG002
HbA1c
Missing HbA1c data for 17, 3, 7 and 8 study participants in the sham+prompt laser, ranibizumab+prompt laser, ranibizumab+deferred laser and triamcinolone+prompt laser groups, respectively.
Median
Inter-Quartile Range
Percentage
Title
Denominators
Categories
Title
Measurements
BG0007.3(6.6 to 8.3)
BG001
Prior cardiovascular event
Based on medical history of condition.
Number
Participants
Title
Denominators
Categories
Yes
Title
Measurements
BG00093
BG00166
BG002
Hypertension
Number
Participants
Title
Denominators
Categories
Yes
Title
Measurements
BG000240
BG001154
BG002
Prior Panretinal Photocoagulation
Number
Eyes
Title
Denominators
Categories
Yes
Title
Measurements
BG00048
BG00136
BG002
Prior treatment for diabetic macular edema
Number
Eyes
Title
Denominators
Categories
No
Title
Measurements
BG000105
BG00174
BG002
Prior laser for diabetic macular edema
Number
Eyes
Title
Denominators
Categories
Yes
Title
Measurements
BG000173
BG001101
BG002
Prior IVT for diabetic macular edema
IVT = intravitreal triamcinolone
Number
Eyes
Title
Denominators
Categories
Yes
Title
Measurements
BG00039
BG00122
BG002
Prior vitrectomy for diabetic macular edema
Number
Eyes
Title
Denominators
Categories
Yes
Title
Measurements
BG00015
BG0017
BG002
Prior peribulbar triamcinolone for diabetic macular edema
Number
Eyes
Title
Denominators
Categories
Yes
Title
Measurements
BG00012
BG0019
BG002
Prior anti-VEGF for diabetic macular edema
VEGF = vascular endothelial growth factor
Number
Eyes
Title
Denominators
Categories
Yes
Title
Measurements
BG00024
BG00124
BG002
Intraocular pressure
Median
Inter-Quartile Range
mmHg
Title
Denominators
Categories
Title
Measurements
BG00016(14 to 18)
BG00116(14 to 18)
BG002
Currently on intraocular pressure lowering medicine for glaucoma or ocular hypertension
Number
Eyes
Title
Denominators
Categories
Yes
Title
Measurements
BG0005
BG0016
BG002
Lens status
Based on clinical exam.
Number
Eyes
Title
Denominators
Categories
Phakic
Title
Measurements
BG000192
BG001131
BG002
E-ETDRS Visual Acuity Letter Score
Best corrected visual acuity letter score as measured by a certified tester using an electronic visual acuity testing machine based on the Early Treatment Diabetic Retinopathy Study (ETDRS) method. Best value on the scale 97, worst 0.
Median
Inter-Quartile Range
Letter Score
Title
Denominators
Categories
Title
Measurements
BG00065(56 to 73)
BG001
Central subfield thickness on optical coherence tomography
ETDRS = Early Treatment Diabetic Retinopathy Study; DR = diabetic retinopathy; PDR = proliferative diabetic retinopathy.
Criteria are based on the ETDRS fundus photographic risk factors for the progression of diabetic retinopathy. ETDRS report no. 12. Ophthalmology 1991; 98:823-833
Number
Eyes
Title
Denominators
Categories
Diabetic retinopathy absent
Title
Measurements
BG0005
BG001
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
Secondary
Change in Retinal Thickening of Central Subfield on Optical Coherence Tomography From Baseline to 1 Year
Negative change denotes an improvement.
Posted
Mean
Standard Deviation
microns
from baseline to 1 year
Eyes
Eyes
ID
Title
Description
OG000
Sham+Prompt Laser
Sham injection at randomization plus focal photocoagulation 1 week post-injection. Injections are repeated every 4 weeks with focal photocoagulation given post-injection every 16 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT.
OG001
0.5 mg Ranibizumab+Prompt Laser
0.5 mg intravitreal ranibizumab at randomization plus focal photocoagulation 1 week post-injection. Injections are repeated every 4 weeks with focal photocoagulation given post-injection every 16 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT.
OG002
0.5 mg Ranibizumab+Deferred Laser
0.5 mg intravitreal ranibizumab at randomization, repeated every 4 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT. If improvement has not occured from injections alone, laser can be given starting at the 24 week visit.
OG003
4 mg Triamcinolone+Prompt Laser
4 mg intravitreal triamcinolone at randomization plus focal photocoagulation 1 week post-injection, repeated every 16 weeks with sham injections at 4-week intervals in-between. Retreatment starting at 16 weeks depends on visual acuity and OCT.
Units
Counts
Participants
OG000271
OG001171
OG002175
OG003
Title
Denominators
Categories
Title
Measurements
OG000-102± 151
OG001-131± 129
OG002-137± 136
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Difference in central subfield thickness mean change from sham+prompt laser
ANCOVA
Adjusted for baseline retinal thickness and visual acuity and correlation between two study eyes.
<0.001
Confidence intervals are adjusted for multiple comparisons.
Difference in mean change
-55
2-Sided
95
-78
-32
Superiority or Other (legacy)
Secondary
Number of Injections in First Year
Maximum possible number of injections for each of the following groups: sham+prompt laser=13 sham injections;ranibizumab+prompt laser=13 ranibizumab injections; ranibizumab+deferred laser=13 ranibizumab injections; triamcinolone+prompt laser=4 triamcinolone injections and 9 sham injections.
Sham+prompt laser group listed median excludes 56 eyes among 163 participants with 2 study eyes that were unmasked at baseline because the participant's other eye was in the ranibizumab+deferred laser group, precluding sham injections for the study eye assigned to sham+prompt laser.
Posted
Median
Inter-Quartile Range
Injections
from baseline to 1 year
Eyes
Eyes
ID
Title
Description
OG000
Sham+Prompt Laser
Sham injection at randomization plus focal photocoagulation 1 week post-injection. Injections are repeated every 4 weeks with focal photocoagulation given post-injection every 16 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT.
OG001
0.5 mg Ranibizumab+Prompt Laser
0.5 mg intravitreal ranibizumab at randomization plus focal photocoagulation 1 week post-injection. Injections are repeated every 4 weeks with focal photocoagulation given post-injection every 16 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT.
OG002
Primary
Mean Change in Visual Acuity (Letters) From Baseline to 1 Year Adjusted for Baseline Visual Acuity
Change in best correct visual acuity letter score from baseline to one year as measured by a certified tester using an electronic visual acuity testing machine based on the Early Treatment Diabetic Retinopathy Study (ETDRS) method. A positive change denotes an improvement. Best value on the scale 97, worst 0.
For eyes without any 1-year data the last observation carried forward method was used to impute data for the primary analysis. followed intention to treat principle.
Posted
Mean
Standard Deviation
Letters
from baseline to 1 Year
Eyes
Eyes
ID
Title
Description
OG000
Sham+Prompt Laser
Sham injection at randomization plus focal photocoagulation 1 week post-injection. Injections are repeated every 4 weeks with focal photocoagulation given post-injection every 16 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT.
OG001
0.5 mg Ranibizumab+Prompt Laser
0.5 mg intravitreal ranibizumab at randomization plus focal photocoagulation 1 week post-injection. Injections are repeated every 4 weeks with focal photocoagulation given post-injection every 16 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT.
OG002
0.5 mg Ranibizumab+Deferred Laser
Primary
Distribution of Change in Visual Acuity (Letters) From Baseline to 1 Year
Change in best correct visual acuity letter score as measured by a certified tester using an electronic visual acuity testing machine based on the Early Treatment Diabetic Retinopathy Study (ETDRS) method.
For eyes without any 1-year data the last observation carried forward method was used to impute data for the primary analysis.
Posted
Number
Eyes
from baseline to 1 Year
Eyes
Eyes
ID
Title
Description
OG000
Sham+Prompt Laser
Sham injection at randomization plus focal photocoagulation 1 week post-injection. Injections are repeated every 4 weeks with focal photocoagulation given post-injection every 16 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT.
OG001
0.5 mg Ranibizumab+Prompt Laser
0.5 mg intravitreal ranibizumab at randomization plus focal photocoagulation 1 week post-injection. Injections are repeated every 4 weeks with focal photocoagulation given post-injection every 16 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT.
OG002
0.5 mg Ranibizumab+Deferred Laser
0.5 mg intravitreal ranibizumab at randomization, repeated every 4 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT. If improvement has not occured from injections alone, laser can be given starting at the 24 week visit.
Other Pre-specified
Central Subfield Thickness < 250 With at Least a 25 Micron Decrease From Baseline to 1 Year
Posted
Number
Eyes
1 Year
Eyes
Eyes
ID
Title
Description
OG000
Sham+Prompt Laser
Sham injection at randomization plus focal photocoagulation 1 week post-injection. Injections are repeated every 4 weeks with focal photocoagulation given post-injection every 16 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT.
OG001
0.5 mg Ranibizumab+Prompt Laser
0.5 mg intravitreal ranibizumab at randomization plus focal photocoagulation 1 week post-injection. Injections are repeated every 4 weeks with focal photocoagulation given post-injection every 16 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT.
OG002
0.5 mg Ranibizumab+Deferred Laser
0.5 mg intravitreal ranibizumab at randomization, repeated every 4 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT. If improvement has not occured from injections alone, laser can be given starting at the 24 week visit.
OG003
4 mg Triamcinolone+Prompt Laser
Other Pre-specified
Distribution of Logarithmic Transformation of Optical Coherence Tomography (LogOCT) Improvement and Worsening
Logarithmic transformation of optical coherence tomography central subfield thickness is calculated by taking the log base 10 of the ratio of the central subfield thickness divided by 200 and rounding to the nearest hundredth. The change is the change in the log values.
Posted
Number
Eyes
1 Year
Eyes
Eyes
ID
Title
Description
OG000
Sham+Prompt Laser
Sham injection at randomization plus focal photocoagulation 1 week post-injection. Injections are repeated every 4 weeks with focal photocoagulation given post-injection every 16 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT.
OG001
0.5 mg Ranibizumab+Prompt Laser
0.5 mg intravitreal ranibizumab at randomization plus focal photocoagulation 1 week post-injection. Injections are repeated every 4 weeks with focal photocoagulation given post-injection every 16 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT.
OG002
0.5 mg Ranibizumab+Deferred Laser
0.5 mg intravitreal ranibizumab at randomization, repeated every 4 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT. If improvement has not occured from injections alone, laser can be given starting at the 24 week visit.
Primary
Change in Visual Acuity From Baseline to 1 Year Among Eyes That Were Pseudophakic at Baseline
Posted
Mean
Standard Deviation
Letters
from baseline to 1 Year
Eyes
Eyes
ID
Title
Description
OG000
Sham+Prompt Laser
Sham injection at randomization plus focal photocoagulation 1 week post-injection. Injections are repeated every 4 weeks with focal photocoagulation given post-injection every 16 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT.
OG001
0.5 mg Ranibizumab+Prompt Laser
0.5 mg intravitreal ranibizumab at randomization plus focal photocoagulation 1 week post-injection. Injections are repeated every 4 weeks with focal photocoagulation given post-injection every 16 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT.
OG002
0.5 mg Ranibizumab+Deferred Laser
0.5 mg intravitreal ranibizumab at randomization, repeated every 4 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT. If improvement has not occured from injections alone, laser can be given starting at the 24 week visit.
OG003
4 mg Triamcinolone+Prompt Laser
Primary
Change in Visual Acuity From Baseline to 1 Year Among Eyes That Had Prior Treatment for Diabetic Macular Edema
Posted
Mean
Standard Deviation
Letters
from baseline to 1 Year
ID
Title
Description
OG000
Sham+Prompt Laser
Sham injection at randomization plus focal photocoagulation 1 week post-injection. Injections are repeated every 4 weeks with focal photocoagulation given post-injection every 16 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT.
OG001
0.5 mg Ranibizumab+Prompt Laser
0.5 mg intravitreal ranibizumab at randomization plus focal photocoagulation 1 week post-injection. Injections are repeated every 4 weeks with focal photocoagulation given post-injection every 16 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT.
OG002
0.5 mg Ranibizumab+Deferred Laser
0.5 mg intravitreal ranibizumab at randomization, repeated every 4 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT. If improvement has not occured from injections alone, laser can be given starting at the 24 week visit.
OG003
4 mg Triamcinolone+Prompt Laser
Primary
Change in Visual Acuity From Baseline to 1 Year Grouped by Baseline Visual Acuity Letter Score
Change in best correct visual acuity letter score as measured by a certified tester using an electronic visual acuity testing machine based on the Early Treatment Diabetic Retinopathy Study (ETDRS) method. A positive change denotes an improvement. Best value on the scale 97, worst 0.
Posted
Mean
Standard Deviation
Letters
from baseline to 1 Year
ID
Title
Description
OG000
Sham+Prompt Laser
Sham injection at randomization plus focal photocoagulation 1 week post-injection. Injections are repeated every 4 weeks with focal photocoagulation given post-injection every 16 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT.
OG001
0.5 mg Ranibizumab+Prompt Laser
0.5 mg intravitreal ranibizumab at randomization plus focal photocoagulation 1 week post-injection. Injections are repeated every 4 weeks with focal photocoagulation given post-injection every 16 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT.
OG002
0.5 mg Ranibizumab+Deferred Laser
0.5 mg intravitreal ranibizumab at randomization, repeated every 4 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT. If improvement has not occured from injections alone, laser can be given starting at the 24 week visit.
Primary
Change in Visual Acuity From Baseline to 1 Year Grouped by Optical Coherence Tomography Central Subfield Thickness
Change in best correct visual acuity letter score from baseline to one year as measured by a certified tester using an electronic visual acuity testing machine based on the Early Treatment Diabetic Retinopathy Study (ETDRS) method. A positive change denotes an improvement. Best value on the scale 97, worst 0.
Posted
Mean
Standard Deviation
Letters
from baseline to 1 Year
Eyes
Eyes
ID
Title
Description
OG000
Sham+Prompt Laser
Sham injection at randomization plus focal photocoagulation 1 week post-injection. Injections are repeated every 4 weeks with focal photocoagulation given post-injection every 16 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT.
OG001
0.5 mg Ranibizumab+Prompt Laser
0.5 mg intravitreal ranibizumab at randomization plus focal photocoagulation 1 week post-injection. Injections are repeated every 4 weeks with focal photocoagulation given post-injection every 16 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT.
OG002
0.5 mg Ranibizumab+Deferred Laser
0.5 mg intravitreal ranibizumab at randomization, repeated every 4 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT. If improvement has not occured from injections alone, laser can be given starting at the 24 week visit.
Primary
Change in Visual Acuity From Baseline to 1 Year Grouped by Diabetic Retinopathy Severity
Change in best correct visual acuity letter score from baseline to one year as measured by a certified tester using an electronic visual acuity testing machine based on the Early Treatment Diabetic Retinopathy Study (ETDRS) method. A positive change denotes an improvement. Best value on the scale 97, worst 0.
Posted
Mean
Standard Deviation
Letters
from baseline to 1 Year
eyes
eyes
ID
Title
Description
OG000
Sham+Prompt Laser
Sham injection at randomization plus focal photocoagulation 1 week post-injection. Injections are repeated every 4 weeks with focal photocoagulation given post-injection every 16 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT.
OG001
0.5 mg Ranibizumab+Prompt Laser
0.5 mg intravitreal ranibizumab at randomization plus focal photocoagulation 1 week post-injection. Injections are repeated every 4 weeks with focal photocoagulation given post-injection every 16 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT.
OG002
0.5 mg Ranibizumab+Deferred Laser
0.5 mg intravitreal ranibizumab at randomization, repeated every 4 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT. If improvement has not occured from injections alone, laser can be given starting at the 24 week visit.
Primary
Change in Visual Acuity From Baseline to 1 Year Grouped by Diffuse vs. Focal Edema as Characterized by the Investigator
Change in best correct visual acuity letter score from baseline to one year as measured by a certified tester using an electronic visual acuity testing machine based on the Early Treatment Diabetic Retinopathy Study (ETDRS) method. A positive change denotes an improvement. Best value on the scale 97, worst 0.
Posted
Mean
Standard Deviation
Letters
from baseline to 1 Year
Eyes
Eyes
ID
Title
Description
OG000
Sham+Prompt Laser
Sham injection at randomization plus focal photocoagulation 1 week post-injection. Injections are repeated every 4 weeks with focal photocoagulation given post-injection every 16 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT.
OG001
0.5 mg Ranibizumab+Prompt Laser
0.5 mg intravitreal ranibizumab at randomization plus focal photocoagulation 1 week post-injection. Injections are repeated every 4 weeks with focal photocoagulation given post-injection every 16 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT.
OG002
0.5 mg Ranibizumab+Deferred Laser
0.5 mg intravitreal ranibizumab at randomization, repeated every 4 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT. If improvement has not occured from injections alone, laser can be given starting at the 24 week visit.
Secondary
Number of Laser Treatments Received Prior to the 1 Year Visit
One eye in the sham+prompt laser group did not receive laser until post 1-year due to an adverse event unrelated to study treatment. One eye in the triamcinolone+prompt laser did not receive laser until after 1-year due to missing 2 consecutive visits at the time of required laser treatment.
Number who completed the 1-year visit.
Posted
Number
Eyes
1 Year
Eyes
Eyes
ID
Title
Description
OG000
Sham+Prompt Laser
Sham injection at randomization plus focal photocoagulation 1 week post-injection. Injections are repeated every 4 weeks with focal photocoagulation given post-injection every 16 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT.
OG001
0.5 mg Ranibizumab+Prompt Laser
0.5 mg intravitreal ranibizumab at randomization plus focal photocoagulation 1 week post-injection. Injections are repeated every 4 weeks with focal photocoagulation given post-injection every 16 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT.
OG002
0.5 mg Ranibizumab+Deferred Laser
0.5 mg intravitreal ranibizumab at randomization, repeated every 4 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT. If improvement has not occured from injections alone, laser can be given starting at the 24 week visit.
Other Pre-specified
Eyes With Alternative Treatments Prior to the 1-year Visit
Each combination of treatment only counted once.
Posted
Number
Eyes
1 Year
Eyes
Eyes
ID
Title
Description
OG000
Sham+Prompt Laser
Sham injection at randomization plus focal photocoagulation 1 week post-injection. Injections are repeated every 4 weeks with focal photocoagulation given post-injection every 16 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT.
OG001
0.5 mg Ranibizumab+Prompt Laser
0.5 mg intravitreal ranibizumab at randomization plus focal photocoagulation 1 week post-injection. Injections are repeated every 4 weeks with focal photocoagulation given post-injection every 16 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT.
OG002
0.5 mg Ranibizumab+Deferred Laser
0.5 mg intravitreal ranibizumab at randomization, repeated every 4 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT. If improvement has not occured from injections alone, laser can be given starting at the 24 week visit.
OG003
4 mg Triamcinolone+Prompt Laser
Other Pre-specified
Change From Moderately Severe Non-proliferative Diabetic Retinopathy or Better From Baseline to 1-year
113 eyes had missing or ungradable photos at 1 year. Criteria are based on the ETDRS fundus photographic risk factors for the progression of diabetic retinopathy. ETDRS report no. 12. Ophthalmology 1991; 98:823-833
Posted
Number
Eyes
from baseline to 1 Year
Eyes
Eyes
ID
Title
Description
OG000
Sham
OG001
Ranibizumab
OG002
Triamcinolone
Units
Counts
Participants
OG000
Other Pre-specified
Change From Severe Non-proliferative Diabetic Retinopathy or Worse From Baseline to 1-year
Criteria are based on the ETDRS fundus photographic risk factors for the progression of diabetic retinopathy. ETDRS report no. 12. Ophthalmology 1991; 98:823-833, ETDRS Severity Scale = Diabetic retinopathy absent, minimal non-proliferative diabetic retinopathy (PDR), mild to moderately severe non-PDR, severe non-PDR, scars of full pr partial panretinal photocoagulation present PDR absent, mild to moderate PDR, high risk PDR, cannot grade, missing.
Posted
Number
Eyes
from baseline to 1 Year
Eyes
Eyes
ID
Title
Description
OG000
Sham
OG001
Ranibizumab
OG002
Triamcinolone
Units
Counts
Participants
OG000
Secondary
Percentage of Eyes Receiving Laser at the 48 Week Visit (%)
Posted
Number
Eyes
1 Year
Eyes
Eyes
ID
Title
Description
OG000
Sham+Prompt Laser
Sham injection at randomization plus focal photocoagulation 1 week post-injection. Injections are repeated every 4 weeks with focal photocoagulation given post-injection every 16 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT.
OG001
0.5 mg Ranibizumab+Prompt Laser
0.5 mg intravitreal ranibizumab at randomization plus focal photocoagulation 1 week post-injection. Injections are repeated every 4 weeks with focal photocoagulation given post-injection every 16 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT.
OG002
0.5 mg Ranibizumab+Deferred Laser
0.5 mg intravitreal ranibizumab at randomization, repeated every 4 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT. If improvement has not occured from injections alone, laser can be given starting at the 24 week visit.
OG003
4 mg Triamcinolone+Prompt Laser
4 mg intravitreal triamcinolone at randomization plus focal photocoagulation 1 week post-injection, repeated every 16 weeks with sham injections at 4-week intervals in-between. Retreatment starting at 16 weeks depends on visual acuity and OCT.
Other Pre-specified
Cardiovascular Events According to Antiplatelet Trialists' Collaboration Through 1 Year
Antiplatelet Trialists' Collaboration is a collaborative overview of randomised trials of antiplatelet therapy - I: Prevention of death, myocardial infarction, and stroke by prolonged antiplatelet therapy in various categories of patients. Antiplatelet Trialists' Collaboration. MBJ 1994; 308:81-106. Nonfatal cerebrovascular accident includes ischemic or hemorrhagic or unknown events. Vascular death includes death from any potential vascular or unknown cause.
Study participants with 2 study eyes are assigned to the non-sham group. Multiple events within a study participant are only counted once per event.
Posted
Number
Participants
1 Year
ID
Title
Description
OG000
Sham
OG001
Ranibizumab
OG002
Triamcinolone
Units
Counts
Participants
Secondary
Mean Optical Coherence Tomography Retinal Volume at 1 Year
Posted
Mean
Standard Deviation
mm^3
1 Year
Eyes
Eyes
ID
Title
Description
OG000
Sham+Prompt Laser
Sham injection at randomization plus focal photocoagulation 1 week post-injection. Injections are repeated every 4 weeks with focal photocoagulation given post-injection every 16 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT.
OG001
0.5 mg Ranibizumab+Prompt Laser
0.5 mg intravitreal ranibizumab at randomization plus focal photocoagulation 1 week post-injection. Injections are repeated every 4 weeks with focal photocoagulation given post-injection every 16 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT.
OG002
0.5 mg Ranibizumab+Deferred Laser
0.5 mg intravitreal ranibizumab at randomization, repeated every 4 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT. If improvement has not occured from injections alone, laser can be given starting at the 24 week visit.
OG003
4 mg Triamcinolone+Prompt Laser
4 mg intravitreal triamcinolone at randomization plus focal photocoagulation 1 week post-injection, repeated every 16 weeks with sham injections at 4-week intervals in-between. Retreatment starting at 16 weeks depends on visual acuity and OCT.
Secondary
Mean Change in Optical Coherence Tomography Retinal Volume From Baseline to 1 Year
Posted
Mean
Standard Deviation
mm^3
from baseline to 1 Year
Eyes
Eyes
ID
Title
Description
OG000
Sham+Prompt Laser
Sham injection at randomization plus focal photocoagulation 1 week post-injection. Injections are repeated every 4 weeks with focal photocoagulation given post-injection every 16 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT.
OG001
0.5 mg Ranibizumab+Prompt Laser
0.5 mg intravitreal ranibizumab at randomization plus focal photocoagulation 1 week post-injection. Injections are repeated every 4 weeks with focal photocoagulation given post-injection every 16 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT.
OG002
0.5 mg Ranibizumab+Deferred Laser
0.5 mg intravitreal ranibizumab at randomization, repeated every 4 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT. If improvement has not occured from injections alone, laser can be given starting at the 24 week visit.
OG003
4 mg Triamcinolone+Prompt Laser
Other Pre-specified
Major Ocular Adverse Events During First Year of Follow-Up
Posted
Number
Eyes
1 Year
Eyes
Eyes
ID
Title
Description
OG000
Sham+Prompt Laser
Sham injection at randomization plus focal photocoagulation 1 week post-injection. Injections are repeated every 4 weeks with focal photocoagulation given post-injection every 16 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT.
OG001
0.5 mg Ranibizumab+Prompt Laser
0.5 mg intravitreal ranibizumab at randomization plus focal photocoagulation 1 week post-injection. Injections are repeated every 4 weeks with focal photocoagulation given post-injection every 16 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT.
OG002
0.5 mg Ranibizumab+Deferred Laser
0.5 mg intravitreal ranibizumab at randomization, repeated every 4 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT. If improvement has not occured from injections alone, laser can be given starting at the 24 week visit.
OG003
4 mg Triamcinolone+Prompt Laser
4 mg intravitreal triamcinolone at randomization plus focal photocoagulation 1 week post-injection, repeated every 16 weeks with sham injections at 4-week intervals in-between. Retreatment starting at 16 weeks depends on visual acuity and OCT.
Time Frame
1 Year
Description
All ocular adverse events are listed under treatment group drug. Participants with a systemic adverse event with two study eyes are listed under the sham/ranibizumab or triamcinolone combination.
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
Sham + Prompt Laser
Laser was given within 3 to 10 days after sham injections, Laser = Focal/grid photocoagulation
53
130
139
139
EG001
Ranibizumab + Prompt Laser
0.5 mg intravitreal ranibizumab plus prompt (within 3-10 days after injection) focal/grid photocoagulation
46
131
97
97
EG002
Ranibizumab + Deferred Laser
0.5 mg intravitreal ranibizumab with deferred (24 weeks) focal/grid photocoagulation
41
132
105
105
EG003
Triamcinolone + Prompt Laser
4 mg intravitreal triamcinolone plus prompt (within 3-10 days after injection) focal/grid photocoagulation
57
135
145
145
EG004
Sham + Ranibizumab + Laser
Participants in this group had 2 study eyes, the right eye was assigned randomly with equal probability to one of the four groups (Sham + prompt laser, ranibizumab + prompt laser, ranibizumab + deferred laser, triamcinolone + prompt laser). If the right eye was assigned to a treatment group other than the sham + prompt laser group, then the left eye was assigned to the sham + prompt laser group. If the right eye was assigned to the sham prompt + prompt laser group, then the left eye was assigned randomly to one of the other three groups.
21
56
0
0
EG005
Sham + Ranibizumab + Deferred Laser
Participants in this group had 2 study eyes, the right eye was assigned randomly with equal probability to one of the four groups (Sham + prompt laser, ranibizumab + prompt laser, ranibizumab + deferred laser, triamcinolone + prompt laser). If the right eye was assigned to a treatment group other than the sham + prompt laser group, then the left eye was assigned to the sham + prompt laser group. If the right eye was assigned to the sham prompt + prompt laser group, then the left eye was assigned randomly to one of the other three groups.
20
56
0
0
EG006
Sham + Triamcinolone + Laser
Participants in this group had 2 study eyes, the right eye was assigned randomly with equal probability to one of the four groups (Sham + prompt laser, ranibizumab + prompt laser, ranibizumab + deferred laser, triamcinolone + prompt laser). If the right eye was assigned to a treatment group other than the sham + prompt laser group, then the left eye was assigned to the sham + prompt laser group. If the right eye was assigned to the sham prompt + prompt laser group, then the left eye was assigned randomly to one of the other three groups.
12
51
0
0
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Abdominal neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (Unspecified)
Non-systematic Assessment
EG0001 affected130 at risk
EG0010 affected131 at risk
EG0020 affected132 at risk
EG0030 affected135 at risk
EG004
Abdominal pain
General disorders
MedDRA (Unspecified)
Non-systematic Assessment
EG0000 affected130 at risk
EG0010 affected131 at risk
EG0020 affected132 at risk
EG003
Anemia
General disorders
MedDRA (Unspecified)
Non-systematic Assessment
EG0000 affected130 at risk
EG0011 affected131 at risk
EG0021 affected132 at risk
EG003
Angina pectoris
General disorders
MedDRA (Unspecified)
Non-systematic Assessment
EG0001 affected130 at risk
EG0010 affected131 at risk
EG0020 affected132 at risk
EG003
Arrhythmia
Cardiac disorders
MedDRA (Unspecified)
Non-systematic Assessment
EG0001 affected130 at risk
EG0011 affected131 at risk
EG0020 affected132 at risk
EG003
Arterial bypass operation
Surgical and medical procedures
MedDRA (Unspecified)
Non-systematic Assessment
EG0000 affected130 at risk
EG0011 affected131 at risk
EG0020 affected132 at risk
EG003
Arteriosclerosis coronary artery
Vascular disorders
MedDRA (Unspecified)
Non-systematic Assessment
EG0001 affected130 at risk
EG0010 affected131 at risk
EG0021 affected132 at risk
EG003
Blood potassium increased
General disorders
MedDRA (Unspecified)
Non-systematic Assessment
EG0001 affected130 at risk
EG0010 affected131 at risk
EG0022 affected132 at risk
EG003
Breast cancer
Reproductive system and breast disorders
MedDRA (Unspecified)
Non-systematic Assessment
EG0000 affected130 at risk
EG0010 affected131 at risk
EG0021 affected132 at risk
EG003
Bronchitis
Respiratory, thoracic and mediastinal disorders
MedDRA (Unspecified)
Non-systematic Assessment
EG0001 affected130 at risk
EG0010 affected131 at risk
EG0020 affected132 at risk
EG003
Cardiac failure
Cardiac disorders
MedDRA (Unspecified)
Non-systematic Assessment
EG0000 affected130 at risk
EG0011 affected131 at risk
EG0020 affected132 at risk
EG003
Cardiac failure congestive
Cardiac disorders
MedDRA (Unspecified)
Non-systematic Assessment
EG0002 affected130 at risk
EG0018 affected131 at risk
EG0020 affected132 at risk
EG003
Cardio-respiratory arrest
Cardiac disorders
MedDRA (Unspecified)
Non-systematic Assessment
EG0000 affected130 at risk
EG0010 affected131 at risk
EG0020 affected132 at risk
EG003
Cardiomegaly
Cardiac disorders
MedDRA (Unspecified)
Non-systematic Assessment
EG0000 affected130 at risk
EG0010 affected131 at risk
EG0020 affected132 at risk
EG003
Cellulitis
General disorders
MedDRA (Unspecified)
Non-systematic Assessment
EG0000 affected130 at risk
EG0012 affected131 at risk
EG0020 affected132 at risk
EG003
cerebrovascular accident
Vascular disorders
MedDRA (Unspecified)
Non-systematic Assessment
EG0001 affected130 at risk
EG0010 affected131 at risk
EG0022 affected132 at risk
EG003
Chest pain
General disorders
MedDRA (Unspecified)
Non-systematic Assessment
EG0005 affected130 at risk
EG0010 affected131 at risk
EG0023 affected132 at risk
EG003
Convulsion
General disorders
MedDRA (Unspecified)
Non-systematic Assessment
EG0000 affected130 at risk
EG0010 affected131 at risk
EG0020 affected132 at risk
EG003
Coronary arterial stent insertion
Surgical and medical procedures
MedDRA (Unspecified)
Non-systematic Assessment
EG0000 affected130 at risk
EG0011 affected131 at risk
EG0021 affected132 at risk
EG003
Coronary artery disease
Vascular disorders
MedDRA (Unspecified)
Non-systematic Assessment
EG0000 affected130 at risk
EG0011 affected131 at risk
EG0020 affected132 at risk
EG003
Death
General disorders
MedDRA (Unspecified)
Non-systematic Assessment
EG0002 affected130 at risk
EG0011 affected131 at risk
EG0022 affected132 at risk
EG003
Dehydration
General disorders
MedDRA (Unspecified)
Non-systematic Assessment
EG0002 affected130 at risk
EG0010 affected131 at risk
EG0021 affected132 at risk
EG003
Diabetes mellitus
Endocrine disorders
MedDRA (Unspecified)
Non-systematic Assessment
EG0000 affected130 at risk
EG0010 affected131 at risk
EG0020 affected132 at risk
EG003
Diabetes mellitus inadequate control
Endocrine disorders
MedDRA (Unspecified)
Non-systematic Assessment
EG0000 affected130 at risk
EG0010 affected131 at risk
EG0020 affected132 at risk
EG003
Diabetic ketoacidosis
Endocrine disorders
MedDRA (Unspecified)
Non-systematic Assessment
EG0000 affected130 at risk
EG0010 affected131 at risk
EG0020 affected132 at risk
EG003
Dysarthria
General disorders
MedDRA (Unspecified)
Non-systematic Assessment
EG0000 affected130 at risk
EG0010 affected131 at risk
EG0020 affected132 at risk
EG003
Dyspnoea
General disorders
MedDRA (Unspecified)
Non-systematic Assessment
EG0001 affected130 at risk
EG0010 affected131 at risk
EG0020 affected132 at risk
EG003
Facial bones fracture
Musculoskeletal and connective tissue disorders
MedDRA (Unspecified)
Non-systematic Assessment
EG0000 affected130 at risk
EG0011 affected131 at risk
EG0020 affected132 at risk
EG003
Food poisoning
Gastrointestinal disorders
MedDRA (Unspecified)
Non-systematic Assessment
EG0000 affected130 at risk
EG0010 affected131 at risk
EG0020 affected132 at risk
EG003
Fracture
Musculoskeletal and connective tissue disorders
MedDRA (Unspecified)
Non-systematic Assessment
EG0000 affected130 at risk
EG0011 affected131 at risk
EG0020 affected132 at risk
EG003
Gastroenteritis
Gastrointestinal disorders
MedDRA (Unspecified)
Non-systematic Assessment
EG0000 affected130 at risk
EG0010 affected131 at risk
EG0020 affected132 at risk
EG003
Gastroesophageal reflux disease
Gastrointestinal disorders
MedDRA (Unspecified)
Non-systematic Assessment
EG0001 affected130 at risk
EG0010 affected131 at risk
EG0020 affected132 at risk
EG003
Goitre
General disorders
MedDRA (Unspecified)
Non-systematic Assessment
EG0000 affected130 at risk
EG0010 affected131 at risk
EG0020 affected132 at risk
EG003
Haematochezia
General disorders
MedDRA (Unspecified)
Non-systematic Assessment
EG0001 affected130 at risk
EG0010 affected131 at risk
EG0020 affected132 at risk
EG003
Heart rate increased
Cardiac disorders
MedDRA (Unspecified)
Non-systematic Assessment
EG0000 affected130 at risk
EG0010 affected131 at risk
EG0021 affected132 at risk
EG003
Heart rate irregular
Cardiac disorders
MedDRA (Unspecified)
Non-systematic Assessment
EG0000 affected130 at risk
EG0011 affected131 at risk
EG0020 affected132 at risk
EG003
Hernia
General disorders
MedDRA (Unspecified)
Non-systematic Assessment
EG0000 affected130 at risk
EG0010 affected131 at risk
EG0020 affected132 at risk
EG003
Hyperglycaemia
General disorders
MedDRA (Unspecified)
Non-systematic Assessment
EG0001 affected130 at risk
EG0010 affected131 at risk
EG0022 affected132 at risk
EG003
Hypertension
Vascular disorders
MedDRA (Unspecified)
Non-systematic Assessment
EG0001 affected130 at risk
EG0010 affected131 at risk
EG0022 affected132 at risk
EG003
Hypotension
Vascular disorders
MedDRA (Unspecified)
Non-systematic Assessment
EG0000 affected130 at risk
EG0011 affected131 at risk
EG0020 affected132 at risk
EG003
Hysterectomy
Surgical and medical procedures
MedDRA (Unspecified)
Non-systematic Assessment
EG0000 affected130 at risk
EG0010 affected131 at risk
EG0020 affected132 at risk
EG003
Impaired gastric emptying
Gastrointestinal disorders
MedDRA (Unspecified)
Non-systematic Assessment
EG0000 affected130 at risk
EG0010 affected131 at risk
EG0022 affected132 at risk
EG003
Infection
Infections and infestations
MedDRA (Unspecified)
Non-systematic Assessment
EG0001 affected130 at risk
EG0010 affected131 at risk
EG0020 affected132 at risk
EG003
Influenza
Respiratory, thoracic and mediastinal disorders
MedDRA (Unspecified)
Non-systematic Assessment
EG0000 affected130 at risk
EG0010 affected131 at risk
EG0021 affected132 at risk
EG003
Ischaemic stroke
Vascular disorders
MedDRA (Unspecified)
Non-systematic Assessment
EG0003 affected130 at risk
EG0010 affected131 at risk
EG0020 affected132 at risk
EG003
Knee operation
Surgical and medical procedures
MedDRA (Unspecified)
Non-systematic Assessment
EG0000 affected130 at risk
EG0010 affected131 at risk
EG0020 affected132 at risk
EG003
Left ventricular hypertrophy
Cardiac disorders
MedDRA (Unspecified)
Non-systematic Assessment
EG0000 affected130 at risk
EG0010 affected131 at risk
EG0020 affected132 at risk
EG003
Leg amputation
Surgical and medical procedures
MedDRA (Unspecified)
Non-systematic Assessment
EG0001 affected130 at risk
EG0010 affected131 at risk
EG0020 affected132 at risk
EG003
Localised infection
Infections and infestations
MedDRA (Unspecified)
Non-systematic Assessment
EG0000 affected130 at risk
EG0010 affected131 at risk
EG0022 affected132 at risk
EG003
Multiple fractures
Musculoskeletal and connective tissue disorders
MedDRA (Unspecified)
Non-systematic Assessment
EG0001 affected130 at risk
EG0010 affected131 at risk
EG0020 affected132 at risk
EG003
Myocardial infacrtion
Cardiac disorders
MedDRA (Unspecified)
Non-systematic Assessment
EG0003 affected130 at risk
EG0010 affected131 at risk
EG0021 affected132 at risk
EG003
Neuropathy
Nervous system disorders
MedDRA (Unspecified)
Non-systematic Assessment
EG0000 affected130 at risk
EG0010 affected131 at risk
EG0021 affected132 at risk
EG003
Oedema peripheral
General disorders
MedDRA (Unspecified)
Non-systematic Assessment
EG0000 affected130 at risk
EG0011 affected131 at risk
EG0020 affected132 at risk
EG003
Osteomyelitis
Musculoskeletal and connective tissue disorders
MedDRA (Unspecified)
Non-systematic Assessment
EG0000 affected130 at risk
EG0011 affected131 at risk
EG0020 affected132 at risk
EG003
Pain in extremity
General disorders
MedDRA (Unspecified)
Non-systematic Assessment
EG0000 affected130 at risk
EG0010 affected131 at risk
EG0020 affected132 at risk
EG003
Peripheral vascular disorder
Vascular disorders
MedDRA (Unspecified)
Non-systematic Assessment
EG0000 affected130 at risk
EG0011 affected131 at risk
EG0020 affected132 at risk
EG003
Pneumonia
Respiratory, thoracic and mediastinal disorders
MedDRA (Unspecified)
Non-systematic Assessment
EG0002 affected130 at risk
EG0011 affected131 at risk
EG0020 affected132 at risk
EG003
Post procedural complications
General disorders
MedDRA (Unspecified)
Non-systematic Assessment
EG0000 affected130 at risk
EG0010 affected131 at risk
EG0021 affected132 at risk
EG003
Presyncope
General disorders
MedDRA (Unspecified)
Non-systematic Assessment
EG0000 affected130 at risk
EG0010 affected131 at risk
EG0020 affected132 at risk
EG003
Prostate cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (Unspecified)
Non-systematic Assessment
EG0000 affected130 at risk
EG0010 affected131 at risk
EG0021 affected132 at risk
EG003
Pulmonary oedema
General disorders
MedDRA (Unspecified)
Non-systematic Assessment
EG0000 affected130 at risk
EG0011 affected131 at risk
EG0021 affected132 at risk
EG003
Renal failure
Renal and urinary disorders
MedDRA (Unspecified)
Non-systematic Assessment
EG0001 affected130 at risk
EG0013 affected131 at risk
EG0021 affected132 at risk
EG003
Renal failure chronic
Renal and urinary disorders
MedDRA (Unspecified)
Non-systematic Assessment
EG0000 affected130 at risk
EG0011 affected131 at risk
EG0020 affected132 at risk
EG003
Rhabdomyolysis
General disorders
MedDRA (Unspecified)
Non-systematic Assessment
EG0000 affected130 at risk
EG0010 affected131 at risk
EG0021 affected132 at risk
EG003
Shoulder operation
Surgical and medical procedures
MedDRA (Unspecified)
Non-systematic Assessment
EG0000 affected130 at risk
EG0010 affected131 at risk
EG0021 affected132 at risk
EG003
Skin Ulcer
Skin and subcutaneous tissue disorders
MedDRA (Unspecified)
Non-systematic Assessment
EG0001 affected130 at risk
EG0010 affected131 at risk
EG0020 affected132 at risk
EG003
Stent placement
Surgical and medical procedures
MedDRA (Unspecified)
Non-systematic Assessment
EG0001 affected130 at risk
EG0010 affected131 at risk
EG0020 affected132 at risk
EG003
Syncope
General disorders
MedDRA (Unspecified)
Non-systematic Assessment
EG0000 affected130 at risk
EG0012 affected131 at risk
EG0020 affected132 at risk
EG003
Tachycardia
Cardiac disorders
MedDRA (Unspecified)
Non-systematic Assessment
EG0000 affected130 at risk
EG0010 affected131 at risk
EG0020 affected132 at risk
EG003
Throat cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (Unspecified)
Non-systematic Assessment
EG0000 affected130 at risk
EG0010 affected131 at risk
EG0020 affected132 at risk
EG003
Transient ischaemic attack
Cardiac disorders
MedDRA (Unspecified)
Non-systematic Assessment
EG0002 affected130 at risk
EG0010 affected131 at risk
EG0020 affected132 at risk
EG003
Vertigo
General disorders
MedDRA (Unspecified)
Non-systematic Assessment
EG0002 affected130 at risk
EG0010 affected131 at risk
EG0020 affected132 at risk
EG003
Cataract
Eye disorders
MedDRA (Unspecified)
Non-systematic Assessment
EG0001 affected130 at risk
EG0010 affected131 at risk
EG0020 affected132 at risk
EG003
Endophthalmitis
Eye disorders
MedDRA (Unspecified)
Non-systematic Assessment
EG0002 affected130 at risk
EG0011 affected131 at risk
EG0020 affected132 at risk
EG003
Intraocular pressure increased
Eye disorders
MedDRA (Unspecified)
Non-systematic Assessment
EG0000 affected130 at risk
EG0010 affected131 at risk
EG0020 affected132 at risk
EG003
Retinal vein occlusion
Eye disorders
MedDRA (Unspecified)
Non-systematic Assessment
EG0000 affected130 at risk
EG0010 affected131 at risk
EG0020 affected132 at risk
EG003
Arterial occlusive disease
Vascular disorders
MedDRA (Unspecified)
Non-systematic Assessment
EG0000 affected130 at risk
EG0010 affected131 at risk
EG0021 affected132 at risk
EG003
Arthralgia
General disorders
MedDRA (Unspecified)
Non-systematic Assessment
EG0001 affected130 at risk
EG0011 affected131 at risk
EG0020 affected132 at risk
EG003
Atrial fibrillation
General disorders
MedDRA (Unspecified)
Non-systematic Assessment
EG0000 affected130 at risk
EG0011 affected131 at risk
EG0022 affected132 at risk
EG003
Anxiety
General disorders
MedDRA (Unspecified)
Non-systematic Assessment
EG0000 affected130 at risk
EG0011 affected131 at risk
EG0020 affected132 at risk
EG003
Biopsy thyroid gland
Surgical and medical procedures
MedDRA (Unspecified)
Non-systematic Assessment
EG0000 affected130 at risk
EG0010 affected131 at risk
EG0020 affected132 at risk
EG003
Blood glucose decreased
General disorders
MedDRA (Unspecified)
Non-systematic Assessment
EG0000 affected130 at risk
EG0010 affected131 at risk
EG0020 affected132 at risk
EG003
Boneneoplasm malignant
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (Unspecified)
Non-systematic Assessment
EG0000 affected130 at risk
EG0011 affected131 at risk
EG0020 affected132 at risk
EG003
Bradycardia
Cardiac disorders
MedDRA (Unspecified)
Non-systematic Assessment
EG0000 affected130 at risk
EG0011 affected131 at risk
EG0020 affected132 at risk
EG003
Cholecystitis acute
General disorders
MedDRA (Unspecified)
Non-systematic Assessment
EG0000 affected130 at risk
EG0010 affected131 at risk
EG0021 affected132 at risk
EG003
Contusion
General disorders
MedDRA (Unspecified)
Non-systematic Assessment
EG0000 affected130 at risk
EG0010 affected131 at risk
EG0020 affected132 at risk
EG003
Diverticulitis
Gastrointestinal disorders
MedDRA (Unspecified)
Non-systematic Assessment
EG0002 affected130 at risk
EG0010 affected131 at risk
EG0020 affected132 at risk
EG003
Embolism
Vascular disorders
MedDRA (Unspecified)
Non-systematic Assessment
EG0001 affected130 at risk
EG0010 affected131 at risk
EG0020 affected132 at risk
EG003
Gastric bypass
Gastrointestinal disorders
MedDRA (Unspecified)
Non-systematic Assessment
EG0000 affected130 at risk
EG0010 affected131 at risk
EG0020 affected132 at risk
EG003
Gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA (Unspecified)
Non-systematic Assessment
EG0001 affected130 at risk
EG0010 affected131 at risk
EG0020 affected132 at risk
EG003
Gout
General disorders
MedDRA (Unspecified)
Non-systematic Assessment
EG0000 affected130 at risk
EG0010 affected131 at risk
EG0021 affected132 at risk
EG003
Hemiparesis
General disorders
MedDRA (Unspecified)
Non-systematic Assessment
EG0001 affected130 at risk
EG0010 affected131 at risk
EG0020 affected132 at risk
EG003
Hip fracture
Musculoskeletal and connective tissue disorders
MedDRA (Unspecified)
Non-systematic Assessment
EG0001 affected130 at risk
EG0010 affected131 at risk
EG0020 affected132 at risk
EG003
Hypersensitivity
General disorders
MedDRA (Unspecified)
Non-systematic Assessment
EG0000 affected130 at risk
EG0010 affected131 at risk
EG0020 affected132 at risk
EG003
Intervertebral disc protrusion
Musculoskeletal and connective tissue disorders
MedDRA (Unspecified)
Non-systematic Assessment
EG0000 affected130 at risk
EG0010 affected131 at risk
EG0020 affected132 at risk
EG003
Lung cancer metastatic
Respiratory, thoracic and mediastinal disorders
MedDRA (Unspecified)
Non-systematic Assessment
EG0000 affected130 at risk
EG0011 affected131 at risk
EG0020 affected132 at risk
EG003
Lymphoedema
General disorders
MedDRA (Unspecified)
Non-systematic Assessment
EG0000 affected130 at risk
EG0011 affected131 at risk
EG0020 affected132 at risk
EG003
Nausea
General disorders
MedDRA (Unspecified)
Non-systematic Assessment
EG0000 affected130 at risk
EG0010 affected131 at risk
EG0020 affected132 at risk
EG003
Migraine
General disorders
MedDRA (Unspecified)
Non-systematic Assessment
EG0000 affected130 at risk
EG0012 affected131 at risk
EG0020 affected132 at risk
EG003
Pulmonary embolism
Vascular disorders
MedDRA (Unspecified)
Non-systematic Assessment
EG0000 affected130 at risk
EG0010 affected131 at risk
EG0020 affected132 at risk
EG003
Renal failure acute
Renal and urinary disorders
MedDRA (Unspecified)
Non-systematic Assessment
EG0000 affected130 at risk
EG0011 affected131 at risk
EG0020 affected132 at risk
EG003
Salivary gland disorder
General disorders
MedDRA (Unspecified)
Non-systematic Assessment
EG0000 affected130 at risk
EG0011 affected131 at risk
EG0020 affected132 at risk
EG003
Glaucoma
Eye disorders
MedDRA (Unspecified)
Non-systematic Assessment
EG0000 affected130 at risk
EG0010 affected131 at risk
EG0020 affected132 at risk
EG003
Iris neovascularisation
Eye disorders
MedDRA (Unspecified)
Non-systematic Assessment
EG0001 affected130 at risk
EG0010 affected131 at risk
EG0020 affected132 at risk
EG003
Urinary tract infection
Renal and urinary disorders
MedDRA (Unspecified)
Non-systematic Assessment
EG0001 affected130 at risk
EG0010 affected131 at risk
EG0020 affected132 at risk
EG003
Supraventricular tachycardia
Cardiac disorders
MedDRA (Unspecified)
Non-systematic Assessment
EG0000 affected130 at risk
EG0010 affected131 at risk
EG0021 affected132 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA (Unspecified)
Non-systematic Assessment
EG0000 affected130 at risk
EG0010 affected131 at risk
EG0020 affected132 at risk
EG003
hypoglycaemia
General disorders
MedDRA (Unspecified)
Non-systematic Assessment
EG0000 affected130 at risk
EG0010 affected131 at risk
EG0021 affected132 at risk
EG003
Anaemia of Chronic disease
General disorders
MedDRA (Unspecified)
Non-systematic Assessment
EG0000 affected130 at risk
EG0010 affected131 at risk
EG0021 affected132 at risk
EG003
Arteriosclerosis coronary artery
Cardiac disorders
MedDRA (Unspecified)
Non-systematic Assessment
EG0001 affected130 at risk
EG0010 affected131 at risk
EG0021 affected132 at risk
EG003
Joint Injury
General disorders
MedDRA (Unspecified)
Non-systematic Assessment
EG0000 affected130 at risk
EG0011 affected131 at risk
EG0020 affected132 at risk
EG003
Skin Ulcer
General disorders
MedDRA (Unspecified)
Non-systematic Assessment
EG0001 affected130 at risk
EG0010 affected131 at risk
EG0021 affected132 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Cataract
Eye disorders
MedDRA (Unspecified)
Non-systematic Assessment
EG00012 affected139 at risk
EG0019 affected97 at risk
EG00210 affected105 at risk
EG00331 affected145 at risk
EG0040 affected0 at risk
EG0050 affected0 at risk
EG0060 affected0 at risk
Cataract subcapsular
Eye disorders
MedDRA (Unspecified)
Non-systematic Assessment
EG0007 affected139 at risk
EG0015 affected97 at risk
EG0024 affected105 at risk
EG003
Eye pain
Eye disorders
MedDRA (Unspecified)
Non-systematic Assessment
EG00022 affected139 at risk
EG00123 affected97 at risk
EG00220 affected105 at risk
EG003
Myodesopsia
Eye disorders
MedDRA (Unspecified)
Non-systematic Assessment
EG0008 affected139 at risk
EG0014 affected97 at risk
EG00210 affected105 at risk
EG003
Vitreous floaters
Eye disorders
MedDRA (Unspecified)
Non-systematic Assessment
EG0009 affected139 at risk
EG00113 affected97 at risk
EG00211 affected105 at risk
EG003
Conjunctival haemorrhage
Eye disorders
MedDRA (Unspecified)
Non-systematic Assessment
EG0004 affected139 at risk
EG00121 affected97 at risk
EG00225 affected105 at risk
EG003
Eye Irritation
Eye disorders
MedDRA (Unspecified)
Non-systematic Assessment
EG0009 affected139 at risk
EG0018 affected97 at risk
EG00211 affected105 at risk
EG003
Influenza
General disorders
MedDRA (Unspecified)
Non-systematic Assessment
EG00010 affected139 at risk
EG0016 affected97 at risk
EG0026 affected105 at risk
EG003
Intraocular pressure increased
Eye disorders
MedDRA (Unspecified)
Non-systematic Assessment
EG0007 affected139 at risk
EG0014 affected97 at risk
EG0027 affected105 at risk
EG003
Lacrimation increased
Eye disorders
MedDRA (Unspecified)
Non-systematic Assessment
EG0009 affected139 at risk
EG0016 affected97 at risk
EG00216 affected105 at risk
EG003
Maculopathy
Eye disorders
MedDRA (Unspecified)
Non-systematic Assessment
EG00024 affected139 at risk
EG00112 affected97 at risk
EG00214 affected105 at risk
EG003
Nasopharyngitis
General disorders
MedDRA (Unspecified)
Non-systematic Assessment
EG00010 affected139 at risk
EG00110 affected97 at risk
EG00210 affected105 at risk
EG003
Ocular Hyperaemia
Eye disorders
MedDRA (Unspecified)
Non-systematic Assessment
EG0006 affected139 at risk
EG00110 affected97 at risk
EG0025 affected105 at risk
EG003
Upper respiratory tract infection
Respiratory, thoracic and mediastinal disorders
MedDRA (Unspecified)
Non-systematic Assessment
EG0008 affected139 at risk
EG00112 affected97 at risk
EG0027 affected105 at risk
EG003
Vision Blurred
Eye disorders
MedDRA (Unspecified)
Non-systematic Assessment
EG00039 affected139 at risk
EG00116 affected97 at risk
EG00220 affected105 at risk
EG003
Visual Acuity Reduced
Eye disorders
MedDRA (Unspecified)
Non-systematic Assessment
EG00013 affected139 at risk
EG0016 affected97 at risk
EG0028 affected105 at risk
EG003
Visual Disturbance
Eye disorders
MedDRA (Unspecified)
Non-systematic Assessment
EG00013 affected139 at risk
EG0017 affected97 at risk
EG0025 affected105 at risk
EG003
Vitreous haemorrhage
Eye disorders
MedDRA (Unspecified)
Non-systematic Assessment
EG00015 affected139 at risk
EG0013 affected97 at risk
EG0024 affected105 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
Not provided
Results Disclosure Restriction on PI(s)?
No
Other Details
Not provided
Point of Contact
Title
Organization
Phone
Extension
Email
Adam R. Glassman, Director DRCR.net Coordinating Center
Jaeb Center for Health Research
813-975-8690
drcrnet@jaeb.org
ID
Term
D003930
Diabetic Retinopathy
Ancestor Terms
ID
Term
D012164
Retinal Diseases
D005128
Eye Diseases
D003925
Diabetic Angiopathies
D014652
Vascular Diseases
D002318
Cardiovascular Diseases
D048909
Diabetes Complications
D003920
Diabetes Mellitus
D004700
Endocrine System Diseases
Browse Leaves
Not provided
Browse Branches
Not provided
ID
Term
D014222
Triamcinolone Acetonide
D007834
Lasers
D000305
Adrenal Cortex Hormones
D000069579
Ranibizumab
C005703
salicylhydroxamic acid
Ancestor Terms
ID
Term
D014221
Triamcinolone
D011245
Pregnadienes
D011278
Pregnanes
D013256
Steroids
D000072473
Fused-Ring Compounds
D011083
Polycyclic Compounds
D013259
Steroids, Fluorinated
D055096
Optical Devices
D004864
Equipment and Supplies
D055618
Radiation Equipment and Supplies
D006728
Hormones
D006730
Hormones, Hormone Substitutes, and Hormone Antagonists
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
62
(55 to 70)
BG00463(56 to 70)
78
BG00386
BG004372
Male
BG000170
BG001102
BG002110
BG003100
BG004482
134
BG003134
BG004601
African American
Title
Measurements
BG00051
BG00130
BG00225
BG00332
BG004138
Hispanic or Latino
Title
Measurements
BG00034
BG00121
BG00225
BG00315
BG00495
Asian
Title
Measurements
BG0004
BG0011
BG0022
BG0034
BG00411
Native Hawaiian/Other Pacific Islander
Title
Measurements
BG0000
BG0011
BG0020
BG0030
BG0041
More than one race
Title
Measurements
BG0001
BG0011
BG0021
BG0030
BG0043
Unknown/not reported
Title
Measurements
BG0001
BG0012
BG0021
BG0031
BG0045
95
BG00393
BG004429
≤65 (20/50 or worse)
Title
Measurements
BG000147
BG00192
BG00293
BG00393
BG004425
68
BG00353
BG004259
Neither predominantly focal or diffuse
Title
Measurements
BG00071
BG00146
BG00241
BG00348
BG004206
Predominantly diffuse
Title
Measurements
BG000144
BG00181
BG00279
BG00385
BG004389
132
BG003135
BG004528
2 study eyes
Title
Measurements
BG000163
BG00156
BG00256
BG00351
BG004326
15
BG00314
BG00465
Type 2
Title
Measurements
BG000260
BG001172
BG002170
BG003166
BG004768
Uncertain
Title
Measurements
BG0008
BG0014
BG0023
BG0036
BG00421
17
(11 to 22)
BG00317(11 to 24)
BG00416(10 to 23)
7.3
(6.6 to 8.4)
BG0027.5(6.7 to 8.4)
BG0037.4(6.5 to 8.6)
BG0047.3(6.6 to 8.4)
61
BG00361
BG004281
No
Title
Measurements
BG000200
BG001121
BG002127
BG003125
BG004573
156
BG003148
BG004698
No
Title
Measurements
BG00053
BG00133
BG00232
BG00338
BG004156
31
BG00337
BG004152
No
Title
Measurements
BG000245
BG001151
BG002157
BG003149
BG004702
74
BG00361
BG004314
Yes
Title
Measurements
BG000188
BG001113
BG002114
BG003125
BG004540
101
BG003114
BG004489
No
Title
Measurements
BG000120
BG00186
BG00287
BG00372
BG004365
36
BG00331
BG004128
No
Title
Measurements
BG000254
BG001165
BG002152
BG003155
BG004726
5
BG00312
BG00439
No
Title
Measurements
BG000278
BG001180
BG002183
BG003174
BG004815
5
BG0035
BG00431
No
Title
Measurements
BG000281
BG001178
BG002183
BG003181
BG004823
21
BG00320
BG00489
No
Title
Measurements
BG000269
BG001163
BG002167
BG003166
BG004765
16
(14 to 18)
BG00316(14 to 18)
BG00416(14 to 18)
4
BG0032
BG00417
No
Title
Measurements
BG000288
BG001181
BG002184
BG003184
BG004837
134
BG003124
BG004581
Anterior Chamber Intraocular Lense
Title
Measurements
BG0003
BG0011
BG0021
BG0030
BG0045
Posterior Chamber Intraocular Lense
Title
Measurements
BG00098
BG00155
BG00253
BG00362
BG004268
66
(55 to 72)
BG00266(58 to 72)
BG00366(57 to 72)
BG00466(56 to 72)
382
(298 to 488)
BG003374(298 to 463)
BG004381(306 to 485)
8.4
(7.4 to 9.8)
BG0038.5(7.8 to 9.7)
BG0048.5(7.7 to 9.7)
12
BG0038
BG00452
Questionable or definite
Title
Measurements
BG000274
BG001171
BG002174
BG003177
BG004796
Cannot grade or missing
Title
Measurements
BG0000
BG0013
BG0022
BG0031
BG0046
140
BG003146
BG004657
Questionable or definite
Title
Measurements
BG00070
BG00136
BG00245
BG00338
BG004189
Cannot grade
Title
Measurements
BG0001
BG0012
BG0023
BG0032
BG0048
4
BG0023
BG0031
BG00413
Minimal non-proliferative DR
Title
Measurements
BG0002
BG0012
BG0023
BG0033
BG00410
Mild to moderately severe non-proliferative DR
Title
Measurements
BG000171
BG001103
BG002107
BG00395
BG004476
Severe non-proliferative DR
Title
Measurements
BG00022
BG00116
BG00211
BG00315
BG00464
Scars of full or partial PRP present;PDR absent
Title
Measurements
BG00038
BG00130
BG00230
BG00329
BG004127
Mild to moderate proliferative DR
Title
Measurements
BG00033
BG00124
BG00222
BG00334
BG004113
High risk proliferative DR
Title
Measurements
BG0007
BG0014
BG0021
BG0033
BG00415
Cannot grade
Title
Measurements
BG00010
BG0011
BG0022
BG0034
BG00417
Missing
Title
Measurements
BG0005
BG0013
BG0029
BG0032
BG00419
173
Eyes
OG000271
OG001171
OG002175
OG003173
-127
± 140
OG000
OG002
Difference in optical coherence tomography central subfield thickness mean change from sham+prompt laser
ANCOVA
Adjusted for baseline retinal thickness and visual acuity and correlation between two study eyes.
<0.001
Confidence intervals are adjusted for multiple comparisons.
Difference in mean change
-49
2-Sided
95
-72
-26
Superiority or Other (legacy)
OG000
OG003
Difference in optical coherence tomography central subfield thickness mean change from sham+prompt laser
ANCOVA
Adjusted for baseline retinal thickness and visual acuity and correlation between two study eyes.
<0.001
Confidence interval is adjusted for multiple comparisons
Difference in mean change
-52
2-Sided
95
-75
-29
Superiority or Other (legacy)
0.5 mg Ranibizumab+Deferred Laser
0.5 mg intravitreal ranibizumab at randomization, repeated every 4 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT. If improvement has not occured from injections alone, laser can be given starting at the 24 week visit.
OG003
4 mg Triamcinolone+Prompt Laser
4 mg intravitreal triamcinolone at randomization plus focal photocoagulation 1 week post-injection, repeated every 16 weeks with sham injections at 4-week intervals in-between. Retreatment starting at 16 weeks depends on visual acuity and OCT.
Units
Counts
Participants
OG000274
OG001171
OG002178
OG003176
Eyes
OG000274
OG001171
OG002178
OG003176
Title
Denominators
Categories
Title
Measurements
OG00011(8 to 13)
OG0018(6 to 10)
OG0029(6 to 11)
OG0033(2 to 4)
0.5 mg intravitreal ranibizumab at randomization, repeated every 4 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT. If improvement has not occured from injections alone, laser can be given starting at the 24 week visit.
OG003
4 mg Triamcinolone+Prompt Laser
4 mg intravitreal triamcinolone at randomization plus focal photocoagulation 1 week post-injection, repeated every 16 weeks with sham injections at 4-week intervals in-between. Retreatment starting at 16 weeks depends on visual acuity and OCT.
Units
Counts
Participants
OG000293
OG001187
OG002188
OG003186
Eyes
OG000293
OG001187
OG002188
OG003186
Title
Denominators
Categories
Title
Measurements
OG0003± 13
OG0019± 11
OG0029± 12
OG0034± 13
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
Adjusted for baseline visual acuity and correlation between 2 study eyes.
<0.001
Adjusted for multiple comparisons.
Mean Difference (Final Values)
5.8
2-Sided
95
3.2
8.5
Superiority or Other (legacy)
OG000
OG002
ANCOVA
Adjusted for baseline visual acuity and correlation between 2 study eyes.
<0.001
Adjusted for multiple comparisons.
Mean Difference (Final Values)
6.0
2-Sided
95
3.4
8.6
Superiority or Other (legacy)
OG000
OG003
ANCOVA
Adjusted for baseline visual acuity and correlation between 2 study eyes.
0.31
Adjusted for multiple comparisons.
Mean Difference (Final Values)
1.1
2-Sided
95
-1.5
3.7
Superiority or Other (legacy)
OG003
4 mg Triamcinolone+Prompt Laser
4 mg intravitreal triamcinolone at randomization plus focal photocoagulation 1 week post-injection, repeated every 16 weeks with sham injections at 4-week intervals in-between. Retreatment starting at 16 weeks depends on visual acuity and OCT.
Units
Counts
Participants
OG000293
OG001187
OG002188
OG003186
Eyes
OG000293
OG001187
OG002188
OG003186
Title
Denominators
Categories
≥15 letter improvement
Title
Measurements
OG00043
OG00157
OG00252
OG00339
14-10 letter improvement
Title
Measurements
OG00038
OG00138
OG00236
OG003
9-5 letter improvement
Title
Measurements
OG00067
OG00134
OG00254
OG003
Same ±4 letters
Title
Measurements
OG00086
OG00138
OG00235
OG003
5-9 letters worse
Title
Measurements
OG00020
OG00114
OG0025
OG003
10-14 letters worse
Title
Measurements
OG00016
OG0013
OG0022
OG003
≥15 letters worse
Title
Measurements
OG00023
OG0013
OG0024
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Difference in proportion with ≥10 letter improvement for sham+prompt laser at 1 year
Binomial regression
Adjusted for correlation between 2 study eyes and multiple comparisons.
Confidence intervals are adjusted for multiple comparisons.
Proportion
23
2-Sided
95
13
34
Superiority or Other (legacy)
OG000
OG002
Difference in proportion with ≥10 letter improvement from sham+prompt laser at 1 year
Binomial regression
Adjusted for correlation between 2 study eyes and multiple comparisons.
Confidence intervals adjusted for multiple comparisons
Proportion
19
2-Sided
95
9
29
Superiority or Other (legacy)
OG000
OG003
Difference in proportion with ≥10 letter improvement from sham+prompt laser at 1 year
Binomial regression
Adjusted for correlation between 2 study eyes and multiple comparisons.
Confidence intervals adjusted for multiple comparisons
Proportion
6
2-Sided
95
-4
16
Superiority or Other (legacy)
OG000
OG001
Relative risk for ≥10 letter improvement comparison with sham+prompt laser at 1 year
Log-Binomial Regression
Adjusted for correlation between 2 study eyes and multiple comparisons.
<0.001
Confidence intervals are adjusted for multiple comparisons.
Risk Ratio (RR)
1.84
2-Sided
95
1.40
2.42
Superiority or Other (legacy)
OG000
OG002
Relative risk for ≥10 letter improvement comparison with sham+prompt laser at 1 year
Log-Binomial Regression
Adjusted for correlation between 2 study eyes and multiple comparisons.
<0.001
Confidence intervals are adjusted for multiple comparisons.
Risk Ratio (RR)
1.68
2-Sided
95
1.27
2.21
Superiority or Other (legacy)
OG000
OG003
Relative risk for ≥10 letter improvement comparison with sham+prompt laser at 1 year
Log-Binomial Regression
Adjusted for correlation between 2 study eyes and multiple comparisons.
0.16
Confidence intervals are adjusted for multiple comparisons.
Risk Ratio (RR)
1.21
2-Sided
95
0.88
1.66
Eyes were analyzed.
Superiority or Other (legacy)
OG000
OG001
Difference in proportion with ≥10 letter worsening from sham+prompt laser at 1 year
Binomial Regression
Adjusted for correlation between 2 study eyes and multiple comparisons.
Confidence intervals are adjusted for multiple comparisons.
Proportion
-10
2-Sided
95
-16
-5
Superiority or Other (legacy)
OG000
OG002
Difference in proportion with ≥10 letter worsening from sham+prompt laser at 1 year
Binomial Regression
Adjusted for correlation between 2 study eyes and multiple comparisons.
Confidence intervals are adjusted for multiple comparisons.
Proportion
-10
2-Sided
95
-16
-4
Superiority or Other (legacy)
OG000
OG003
Difference in proportion with ≥10 letter worsening from sham+prompt laser at 1 year
Binomial Regression
Adjusted for correlation between 2 study eyes and multiple comparisons.
Confidence intervals are adjusted for multiple comparisons.
Proportion
1
2-Sided
95
-7
9
Superiority or Other (legacy)
OG000
OG001
Relative risk for ≥10 letter worsening comparison with sham+prompt laser at 1 year
Log-Binomial Regression
Adjusted for correlation between 2 study eyes and multiple comparisons.
<0.001
Confidence intervals are adjusted for multiple comparisons.
Risk Ratio (RR)
0.24
2-Sided
95
0.09
0.65
Superiority or Other (legacy)
OG000
OG002
Relative risk for ≥10 letter worsening comparison with sham+prompt laser at 1 year
Log-Binomial Regression
Adjusted for correlation between 2 study eyes and multiple comparisons.
0.001
Confidence intervals are adjusted for multiple comparisons.
Risk Ratio (RR)
0.24
2-Sided
95
0.08
0.68
Superiority or Other (legacy)
OG000
OG003
Relative risk for ≥10 letter worsening comparison with sham+prompt laser at 1 year
Log-Binomial Regression
Adjusted for correlation between 2 study eyes and multiple comparisons.
0.75
Confidence intervals are adjusted for multiple comparisons.
Risk Ratio (RR)
1.08
2-Sided
95
0.62
1.87
Superiority or Other (legacy)
OG000
OG001
Difference in proportion with ≥15 letter improvement from sham+prompt laser at 1 year
Binomial Regression
Adjusted for correlation between to study eyes.
Confidence intervals are adjusted for multiple comparisons.
Proportion
16
2-Sided
95
6
26
Superiority or Other (legacy)
OG000
OG002
Difference in proportion with ≥15 letter improvement from sham+prompt laser at 1 year
Binomial Regression
Adjusted for correlation between 2 study eyes and multiple comparisons.
Confidence intervals are adjusted for multiple comparisons.
Proportion
13
2-Sided
95
4
22
Superiority or Other (legacy)
OG000
OG003
Difference in proportion with ≥15 letter improvement from sham+prompt laser at 1 year
Binomial Regression
Adjusted for correlation between 2 study eyes and multiple comparisons.
Confidence intervals are adjusted for multiple comparisons.
Proportion
6
2-Sided
95
-2
15
Superiority or Other (legacy)
OG000
OG001
Relative risk for ≥15 letter improvement comparison with sham+prompt laser at 1 year
Log-Binomial Regression
Adjusted for correlation between 2 study eyes and multiple comparisons.
<0.001
Risk Ratio (RR)
2.09
2-Sided
95
1.35
3.22
Superiority or Other (legacy)
OG000
OG002
Relative risk for ≥15 letter improvement comparison with sham+prompt laser at 1 year
Log-Binomial Regression
Adjusted for correlation between 2 study eyes and multiple comparisons.
<0.001
Confidence intervals are adjusted for multiple comparisons.
Risk Ratio (RR)
1.89
2-Sided
95
1.25
2.87
Superiority or Other (legacy)
OG000
OG003
Relative risk for ≥15 letter improvement comparison with sham+prompt laser at 1 year
Log-Binomial Regression
Adjusted for correlation between 2 study eyes and multiple comparisons.
0.07
Confidence intervals are adjusted for multiple comparisons.
Risk Ratio (RR)
1.43
2-Sided
95
0.90
2.29
Superiority or Other (legacy)
OG000
OG001
Difference in proportion with ≥15 letter worsening from sham+prompt laser at 1 year
Binomial Regression
Adjusted for correlation between 2 study eyes and multiple comparisons.
Confidence intervals are adjusted for multiple comparisons.
Proportion
-6
2-Sided
95
-11
-2
Superiority or Other (legacy)
OG000
OG002
Difference in proportion with ≥15 letter worsening from sham+prompt laser at 1 year
Binomial Regression
Adjusted for correlation between 2 study eyes and multiple comparisons.
Confidence intervals are adjusted for multiple comparisons.
Proportion
-6
2-Sided
95
-10
-1
Superiority or Other (legacy)
OG000
OG003
Difference in proportion with ≥15 letter worsening from sham+prompt laser at 1 year
Binomial Regression
Adjusted for correlation between 2 study eyes and multiple comparisons.
Confidence intervals are adjusted for multiple comparisons.
Proportion
0
2-Sided
95
-6
6
Superiority or Other (legacy)
OG000
OG001
Relative risk for ≥15 letter worsening comparison with sham+prompt laser at 1 year
Log-Binomial Regression
Adjusted for correlation between 2 study eyes and multiple comparisons.
0.009
Risk Ratio (RR)
0.21
2-Sided
95
0.05
0.87
Superiority or Other (legacy)
OG000
OG002
Relative risk for ≥15 letter worsening comparison with sham+prompt laser at 1 year
Log-Binomial Regression
Adjusted for correlation between 2 study eyes and multiple comparisons.
0.01
Risk Ratio (RR)
0.28
2-Sided
95
0.08
0.97
Superiority or Other (legacy)
OG000
OG003
Relative risk for ≥15 letter worsening comparison with sham+prompt laser at 1 year
Log-Binomial Regression
Adjusted for correlation between 2 study eyes and multiple comparisons.
0.95
Risk Ratio (RR)
1.02
2-Sided
95
0.47
2.20
Superiority or Other (legacy)
4 mg intravitreal triamcinolone at randomization plus focal photocoagulation 1 week post-injection, repeated every 16 weeks with sham injections at 4-week intervals in-between. Retreatment starting at 16 weeks depends on visual acuity and OCT.
Units
Counts
Participants
OG000271
OG001171
OG002175
OG003173
Eyes
OG000271
OG001171
OG002175
OG003173
Title
Denominators
Categories
Title
Measurements
OG00072
OG00191
OG00274
OG00382
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
Relative risk for comparison with sham+prompt laser
Regression, Logistic
Adjusted for correlation between 2 study eyes and multiple comparisons.
<0.001
Confidence intervals are adjusted for multiple comparisons.
Risk Ratio (RR)
2.00
2-Sided
95
1.52
2.64
Superiority or Other (legacy)
OG000
OG002
Relative risk for comparison with sham+prompt laser
Regression, Logistic
Adjusted for correlation between 2 study eyes and multiple comparisons.
0.001
Confidence intervals adjusted for multiple comparisons
Risk Ratio (RR)
1.55
2-Sided
95
1.13
2.13
Superiority or Other (legacy)
OG000
OG003
Relative risk for comparison with sham+prompt laser
Regression, Logistic
Adjusted for correlation between 2 study eyes and multiple comparisons.
<0.001
Confidence intervals adjusted for multiple comparisons.
Risk Ratio (RR)
1.76
95
1.31
2.36
Superiority or Other (legacy)
OG003
4 mg Triamcinolone+Prompt Laser
4 mg intravitreal triamcinolone at randomization plus focal photocoagulation 1 week post-injection, repeated every 16 weeks with sham injections at 4-week intervals in-between. Retreatment starting at 16 weeks depends on visual acuity and OCT.
Units
Counts
Participants
OG000271
OG001171
OG002175
OG003173
Eyes
OG000271
OG001171
OG002175
OG003173
Title
Denominators
Categories
≥2 step improvement
Title
Measurements
OG00081
OG00172
OG00271
OG00365
≥2 step worsening
Title
Measurements
OG0006
OG0011
OG0020
OG003
4 mg intravitreal triamcinolone at randomization plus focal photocoagulation 1 week post-injection, repeated every 16 weeks with sham injections at 4-week intervals in-between. Retreatment starting at 16 weeks depends on visual acuity and OCT.
Units
Counts
Participants
OG000293
OG001187
OG002188
OG003186
Eyes
OG000293
OG001187
OG002188
OG003186
Title
Denominators
Categories
Not pseudophakic at baseline
Title
Measurements
OG0002± 13
OG0019± 10
OG00210± 14
OG0032± 14
Pseudophakic at baseline
Title
Measurements
OG0004± 14
OG0018± 12
OG0027± 9
OG003
4 mg intravitreal triamcinolone at randomization plus focal photocoagulation 1 week post-injection, repeated every 16 weeks with sham injections at 4-week intervals in-between. Retreatment starting at 16 weeks depends on visual acuity and OCT.
Units
Counts
Participants
OG000293
OG001187
OG002188
OG003186
Title
Denominators
Categories
No
Title
Measurements
OG0002± 14
OG0019± 12
OG00211± 13
OG0033± 13
Yes
Title
Measurements
OG0003± 13
OG0019± 10
OG0028± 12
OG003
OG003
4 mg Triamcinolone+Prompt Laser
4 mg intravitreal triamcinolone at randomization plus focal photocoagulation 1 week post-injection, repeated every 16 weeks with sham injections at 4-week intervals in-between. Retreatment starting at 16 weeks depends on visual acuity and OCT.
Units
Counts
Participants
OG000293
OG001187
OG002188
OG003186
Title
Denominators
Categories
≥66 (better than 20/50)
Title
Measurements
OG0001± 12
OG0016± 10
OG0025± 13
OG0031± 11
≤65 (20/50 or worse)
Title
Measurements
OG0005± 14
OG00112± 11
OG00213± 10
OG003
OG003
4 mg Triamcinolone+Prompt Laser
4 mg intravitreal triamcinolone at randomization plus focal photocoagulation 1 week post-injection, repeated every 16 weeks with sham injections at 4-week intervals in-between. Retreatment starting at 16 weeks depends on visual acuity and OCT.
Units
Counts
Participants
OG000293
OG001187
OG002188
OG003186
Eyes
OG000293
OG001187
OG002188
OG003186
Title
Denominators
Categories
<400 microns
Title
Measurements
OG0003± 11
OG0017± 11
OG0027± 12
OG0033± 12
≥400 microns
Title
Measurements
OG0003± 15
OG00111± 10
OG00211± 13
OG003
OG003
4 mg Triamcinolone+Prompt Laser
4 mg intravitreal triamcinolone at randomization plus focal photocoagulation 1 week post-injection, repeated every 16 weeks with sham injections at 4-week intervals in-between. Retreatment starting at 16 weeks depends on visual acuity and OCT.
Units
Counts
Participants
OG000293
OG001187
OG002188
OG003186
eyes
OG000293
OG001187
OG002188
OG003186
Title
Denominators
Categories
Moderately severe non-proliferative DR or better
Title
Measurements
OG0003± 13
OG00110± 11
OG0029± 12
OG0033± 14
Severe non-proliferative DR or worse
Title
Measurements
OG0002± 15
OG0018± 10
OG0029± 13
OG003
OG003
4 mg Triamcinolone+Prompt Laser
4 mg intravitreal triamcinolone at randomization plus focal photocoagulation 1 week post-injection, repeated every 16 weeks with sham injections at 4-week intervals in-between. Retreatment starting at 16 weeks depends on visual acuity and OCT.
Units
Counts
Participants
OG000293
OG001187
OG002188
OG003186
Eyes
OG000293
OG001187
OG002188
OG003186
Title
Denominators
Categories
Typical/predominantly focal
Title
Measurements
OG0003± 13
OG0018± 11
OG0028± 13
OG0033± 11
Neither predominantly focal nor diffuse
Title
Measurements
OG0002± 14
OG00110± 9
OG0028± 15
OG003
Typical/predominantly diffuse
Title
Measurements
OG0003± 13
OG0019± 12
OG00210± 10
OG003
OG003
4 mg Triamcinolone+Prompt Laser
4 mg intravitreal triamcinolone at randomization plus focal photocoagulation 1 week post-injection, repeated every 16 weeks with sham injections at 4-week intervals in-between. Retreatment starting at 16 weeks depends on visual acuity and OCT.
Units
Counts
Participants
OG000274
OG001171
OG002178
OG003176
Eyes
OG000274
OG001171
OG002178
OG003176
Title
Denominators
Categories
0
Title
Measurements
OG0001
OG0010
OG002124
OG0031
1
Title
Measurements
OG00035
OG00153
OG00236
OG003
2
Title
Measurements
OG00075
OG00154
OG00217
OG003
3
Title
Measurements
OG000107
OG00146
OG0021
OG003
4
Title
Measurements
OG00056
OG00118
OG0020
OG003
4 mg intravitreal triamcinolone at randomization plus focal photocoagulation 1 week post-injection, repeated every 16 weeks with sham injections at 4-week intervals in-between. Retreatment starting at 16 weeks depends on visual acuity and OCT.
Units
Counts
Participants
OG000293
OG001187
OG002188
OG003186
Eyes
OG000293
OG001187
OG002188
OG003186
Title
Denominators
Categories
Intravitreal bevacizumab
Title
Measurements
OG0003
OG0010
OG0020
OG0031
Intravitreal triamcinolone acetonide
Title
Measurements
OG0005
OG0010
OG0020
OG003
Vitrectomy
Title
Measurements
OG0002
OG0010
OG0020
OG003
Intravitreal bevacizumab+triamcinolone acetonide
Title
Measurements
OG0004
OG0010
OG0020
OG003
Total number of eyes with alternative treatments
Title
Measurements
OG00014
OG0011
OG0020
OG003
Total number of treatments applied
Title
Measurements
OG00025
OG0011
OG0020
OG003
Total per protocol treatments applied
Title
Measurements
OG0005
OG0011
OG0020
OG003
Total deviations from protocol treatments applied
Title
Measurements
OG0009
OG0010
OG0020
OG003
150
OG001182
OG00280
Eyes
OG000150
OG001182
OG00280
Title
Denominators
Categories
Improved by 2 or more levels
Title
Measurements
OG0006
OG00146
OG00220
Worsened by 2 or more levels
Title
Measurements
OG00011
OG0015
OG0022
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
P value for comparison with sham
GEE repeated measures
0.08
95
Superiority or Other (legacy)
OG000
OG002
P value for comparison with sham
GEE repeated measures
0.17
95
Superiority or Other (legacy)
83
OG001121
OG00270
Eyes
OG00083
OG001121
OG00270
Title
Denominators
Categories
Improved by 2 or more levels
Title
Measurements
OG00010
OG00118
OG0026
Worsened by 2 or more levels
Title
Measurements
OG0007
OG0011
OG0022
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
P value for comparison with sham
GEE repeated measures
0.03
95
Superiority or Other (legacy)
OG000
OG002
P value for comparison with sham
GEE repeated measures
0.17
95
Superiority or Other (legacy)
Units
Counts
Participants
OG000274
OG001171
OG002178
OG003176
Eyes
OG000274
OG001171
OG002178
OG003176
Title
Denominators
Categories
Title
Measurements
OG00026
OG00116
OG0028
OG00321
OG000
130
OG001375
OG002186
Title
Denominators
Categories
Nonfatal myocardial infarction
Title
Measurements
OG0003
OG0011
OG0022
Nonfatal cerebrovascular accident
Title
Measurements
OG0005
OG0013
OG0021
Vascular death
Title
Measurements
OG0004
OG0017
OG0022
Any ATC cardiovascular event
Title
Measurements
OG00010
OG00111
OG0025
Units
Counts
Participants
OG000293
OG001187
OG002188
OG003186
Eyes
OG000293
OG001187
OG002188
OG003186
Title
Denominators
Categories
Title
Measurements
OG0008.1± 1.4
OG0017.3± 1.0
OG0027.4± 1.2
OG0037.5± 1.3
4 mg intravitreal triamcinolone at randomization plus focal photocoagulation 1 week post-injection, repeated every 16 weeks with sham injections at 4-week intervals in-between. Retreatment starting at 16 weeks depends on visual acuity and OCT.
Units
Counts
Participants
OG000293
OG001187
OG002188
OG003186
Eyes
OG000293
OG001187
OG002188
OG003186
Title
Denominators
Categories
Title
Measurements
OG000-1.0± 1.4
OG001-1.4± 1.4
OG002-1.5± 1.5
OG003-1.4± 1.6
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
Difference in mean change from sham+prompt laser
ANCOVA
Adjusted for baseline optical coherence tomography (OCT) retinal volume, OCT retinal thickness and visual acuity and correlation between 2 study eyes.
<0.001
Confidence intervals are adjusted for multiple comparisons.
Mean Difference (Net)
-0.73
2-Sided
95
-1.01
-0.44
Superiority or Other (legacy)
OG000
OG002
Difference in mean change from sham+prompt laser
ANCOVA
Adjusted for baseline optical coherence tomography (OCT) retinal volume, OCT retinal thickness and visual acuity and correlation between 2 study eyes.
<0.001
Confidence intervals adjusted for multiple comparisons.
Mean Difference (Net)
-0.68
2-Sided
95
-0.96
-0.41
Superiority or Other (legacy)
OG000
OG003
Difference in mean change from sham+prompt laser
ANCOVA
Adjusted for baseline optical coherence tomography (OCT) retinal volume, OCT retinal thickness and visual acuity and correlation between 2 study eyes.
<0.001
Confidence intervals are adjusted for multiple comparisons.