Comparative Effectiveness Study of Intravitreal Aflibercept, Bevacizumab, and Ranibizumab for Diabetic Macular Edema
Protocol T
A Comparative Effectiveness Study of Intravitreal Aflibercept, Bevacizumab and Ranibizumab for Diabetic Macular Edema
4 other identifiers
interventional
660
1 country
90
Brief Summary
Although multiple studies have suggested that treatment with ranibizumab is safe and efficacious and superior to focal/grid laser alone for patients with center-involved diabetic macular edema (DME), there may be barriers in place to widespread adoption of ranibizumab use given its high cost per dose and the need for multiple treatments over time. Prioritizing resources from a public health policy perspective could be easier if more precise estimates regarding the risks and benefits of other anti-vascular endothelial growth factor (anti-VEGF) therapies were available, especially when the difference in costs could be billions of dollars over just a few years. Thus, there is a clear rationale at this time to explore potential anti-VEGF alternatives to ranibizumab that might prove to be as or more efficacious, might deliver equally lasting or longer-lasting treatment effects, and cost substantially less. Of the potentially available alternative anti-VEGF agents for this trial, bevacizumab and aflibercept are the best candidates for a direct comparison study. Bevacizumab shares the most similar molecular structure, costs far less, and is widely available. Furthermore, there is already preliminary evidence to suggest that it may be efficacious in the treatment of DME and it is already being widely used for this indication. Although aflibercept has a similar cost per unit dose to ranibizumab, it has the potential to decrease treatment burden and associated cost. If results from a comparative trial demonstrate improved efficacy or suggest similar efficacy of bevacizumab or aflibercept over ranibizumab, this information might give clinicians scientific rationale to substitute either one of these drugs for ranibizumab in the treatment of DME, and might thereby have substantial implications for public policy in terms of future estimates of health care dollars and possibly number of treatments necessary for anti-VEGF treatment of diabetic macular disease. Because of its availability and lower cost, bevacizumab is already currently in widespread clinical use for treatment of DME despite the lack of FDA approval for this indication. Thus, a clinical trial that suggested whether bevacizumab could be used as a safe and efficacious alternative to ranibizumab could substantially impact nationwide practice patterns for treatment of DME by either validating the current use of bevacizumab or by demonstrating improved outcomes with ranibizumab or aflibercept treatment for DME. Study Objective The primary objective of the proposed research is to compare the efficacy and safety of (1) intravitreal aflibercept, (2) intravitreal bevacizumab, and (3) intravitreal ranibizumab when given to treat central-involved DME in eyes with visual acuity of 20/32 to 20/320.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Aug 2012
Longer than P75 for phase_3
90 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 21, 2012
CompletedFirst Posted
Study publicly available on registry
June 25, 2012
CompletedStudy Start
First participant enrolled
August 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2014
CompletedResults Posted
Study results publicly available
December 16, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
April 18, 2019
CompletedAugust 10, 2020
July 1, 2020
2.2 years
June 21, 2012
September 29, 2015
July 22, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Overall Change in Electronic Early Treatment Diabetic Retinopathy Study Visual Acuity Letter Score From Baseline to 1-year
Visual Acuity was measured with the Electronic Early Treatment Study (E-ETDRS) visual acuity test. Unit of measure is based on the E-ETDRS letter score scale, 0-97, where 0 = worst and 97 = best.
Baseline to 1-year
Change in Electronic Early Treatment Diabetic Retinopathy Study Visual Acuity Letter Score From Baseline to 1-year: Baseline Visual Acuity Letter Score <69
Visual Acuity was measured with the Electronic Early Treatment Study (E-ETDRS) visual acuity test. Unit of measure is based on the E-ETDRS letter score scale, 0-97, where 0 = worst and 97 = best.
Baseline to 1-year
Change in Electronic Early Treatment Diabetic Retinopathy Study Visual Acuity Letter Score From Baseline to 1-year: Baseline Visual Acuity Letter Score 78-69
Visual Acuity was measured with the Electronic Early Treatment Study (E-ETDRS) visual acuity test. Unit of measure is based on the E-ETDRS letter score scale, 0-97, where 0 = worst and 97 = best.
Baseline to 1-year
Secondary Outcomes (7)
Overall Change in Optical Coherence Tomography Central Subfield Thickness
baseline to 1-year
Change in Optical Coherence Tomography Central Subfield Thickness: Baseline Visual Acuity Letter Score <69
baseline to 1-year
Change in Optical Coherence Tomography Central Subfield Thickness: Baseline Visual Acuity Letter Score 78-69
baseline to 1-year
Overall Change in Retinal Volume
Baseline to 1-year
Total Number of Injections Prior to 1 Year
Baseline to 1-year
- +2 more secondary outcomes
Study Arms (3)
Ranibizumab
ACTIVE COMPARATORAflibercept
EXPERIMENTALBevacizumab
EXPERIMENTALInterventions
Intravitreal injection of 2.0 mg aflibercept at baseline and up to every 4 weeks using defined retreatment criteria.
Intravitreal injection of 1.25 mg bevacizumab at baseline and up to every 4 weeks using defined retreatment criteria.
Intravitreal injection of 0.3 mg ranibizumab (Lucentisâ„¢) at baseline and up to every 4 weeks using defined retreatment criteria.
Eligibility Criteria
You may qualify if:
- Age ≥ 18 years
- Individuals \<18 years old are not being included because DME is so rare in this age group that the diagnosis of DME may be questionable.
- Diagnosis of diabetes mellitus (type 1 or type 2)
- Any one of the following will be considered to be sufficient evidence that diabetes is present:
- Current regular use of insulin for the treatment of diabetes
- Current regular use of oral anti-hyperglycemia agents for the treatment of diabetes
- Documented diabetes by American Diabetes Association and/or World Health Organization criteria (see Procedures Manual for definitions)
- At least one eye meets the following study eye criteria:
- Best corrected Electronic-Early Treatment Diabetic Retinopathy Study visual acuity letter score ≤ 78 (i.e., 20/32 or worse) and ≥ 24 (i.e., 20/320 or better) within eight days of randomization.
- On clinical exam, definite retinal thickening due to diabetic macular edema involving the center of the macula.
- Diabetic macular edema present on optical coherence tomography (OCT) (central subfield thickness on OCT \>250 µm on Zeiss Stratus or the equivalent on spectral domain OCTs based on gender specific cutoffs), within eight days of randomization.
- Investigator must verify accuracy of OCT scan by ensuring it is centered and of adequate quality (for Zeiss Stratus, standard deviation of center point thickness should be ≤ 10% of the center point thickness and signal strength should be ≥ 6)
- Media clarity, pupillary dilation, and individual cooperation sufficient for adequate fundus photographs
- Able and willing to provide informed consent.
You may not qualify if:
- 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).
- Individuals in poor glycemic control who, within the last four months, initiated intensive insulin treatment (a pump or multiple daily injections) or plan to do so in the next four months should not be enrolled.
- Participation in an investigational trial within 30 days of randomization that involved treatment with any drug that has not received regulatory approval for the indication being studied at the time of study entry.
- Note: study participants cannot receive another investigational drug while participating in the study.
- Known allergy to any component of the study drug.
- Blood pressure \> 180/110 (systolic above 180 OR diastolic above 110).
- If blood pressure is brought below 180/110 by anti-hypertensive treatment, individual can become eligible.
- Myocardial infarction, other acute cardiac event requiring hospitalization, stroke, transient ischemic attack, or treatment for acute congestive heart failure within 4 months prior to randomization.
- Systemic anti-VEGF or pro-VEGF treatment within four months prior to randomization or anticipated use during the study.
- These drugs cannot be used during the study.
- For women of child-bearing potential: pregnant or lactating or intending to become pregnant within the next 24 months.
- Women who are potential study participants should be questioned about the potential for pregnancy. Investigator judgment is used to determine when a pregnancy test is needed.
- Individual 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.
- Macular edema is considered to be due to a cause other than diabetic macular edema.
- +11 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Jaeb Center for Health Researchlead
- National Eye Institute (NEI)collaborator
- Genentech, Inc.collaborator
- Regeneron Pharmaceuticalscollaborator
Study Sites (90)
Retina Associates
Tucson, Arizona, 85710, United States
Retina-Vitreous Associates Medical Group
Beverly Hills, California, 90211, United States
Loma Linda University Health Care, Dept. of Ophthalmology
Loma Linda, California, 92354, United States
Southern California Desert Retina Consultants, MC
Palm Desert, California, 92211, United States
California Retina Consultants
Santa Barbara, California, 93103, United States
Bay Area Retina Associates
Walnut Creek, California, 94598, United States
Retinal Consultants of Southern California Medical Group, Inc.
Westlake Village, California, 91361, United States
New England Retina Associates
Norwich, Connecticut, 06360, United States
Gulf Coast Retina Center
Clearwater, Florida, 33761, United States
Retina Group of Florida
Fort Lauderdale, Florida, 33334, United States
National Ophthalmic Research Institute
Fort Myers, Florida, 33912, United States
Central Florida Retina Institute
Lakeland, Florida, 33805, United States
Ocala Eye Retina Consultants
Ocala, Florida, 34474, United States
Magruder Eye Institute
Orlando, Florida, 32803, United States
Fort Lauderdale Eye Institute
Plantation, Florida, 33324, United States
Sarasota Retina Institute
Sarasota, Florida, 34239, United States
Retina Associates of Florida, P.A.
Tampa, Florida, 33609, United States
Emory Eye Center
Atlanta, Georgia, 30322, United States
Georgia Retina, P.C.
Atlanta, Georgia, 30342, United States
Thomas Eye Group
Atlanta, Georgia, 30342, United States
Southeast Retina Center, P.C.
Augusta, Georgia, 30909, United States
Retina Consultants of Hawaii, Inc.
Honolulu, Hawaii, 96701, United States
Northwestern Medical Faculty Foundation
Chicago, Illinois, 60611, United States
University of Illinois at Chicago Medical Center
Chicago, Illinois, 60612, United States
NorthShore University HealthSystem
Glenview, Illinois, 60026, 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
Wolfe Eye Clinic
West Des Moines, Iowa, 50266, United States
Retina Associates, P.A.
Shawnee Mission, Kansas, 66204, 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
Ophthalmic Consultants of Boston
Boston, Massachusetts, 02114, United States
Joslin Diabetes Center
Boston, Massachusetts, 02215, United States
Vitreo-Retinal Associates, PC
Worcester, Massachusetts, 01605, United States
Henry Ford Health System, Dept of Ophthalmology and Eye Care Services
Detroit, Michigan, 48202, United States
Retina Vitrous Center
Grand Blanc, Michigan, 48439, United States
Retina Specialists of Michigan
Grand Rapids, Michigan, 49525, United States
Vitreo-Retinal Associates
Grand Rapids, Michigan, 49525, United States
Retina Center, PA
Minneapolis, Minnesota, 55404, United States
Mayo Clinic Department of Ophthalmology
Rochester, Minnesota, 55905, United States
Barnes Retina Institute
St Louis, Missouri, 63110, United States
Eyesight Ophthalmic Services, PA
Portsmouth, New Hampshire, 03801, United States
The Institute of Ophthalmology and Visual Science (IOVS)
Newark, New Jersey, 07103, United States
Eye Associates of New Mexico
Albuquerque, New Mexico, 87102, United States
University of New Mexico Health Sciences Center
Albuquerque, New Mexico, 871310001, United States
The New York Eye and Ear Infirmary/Faculty Eye Practice
New York, New York, 10003, United States
MaculaCare
New York, New York, 10021, United States
Mount Sinai School of Medicine, Dept. of Ophthalmology
New York, New York, 10029, United States
Retina Associates of Western New York
Rochester, New York, 14618, United States
University of Rochester
Rochester, New York, 14642, United States
Retina-Vitreous Surgeons of Central New York, PC
Syracuse, New York, 13224, United States
Montefiore Medical Center
The Bronx, New York, 10467-2401, United States
Western Carolina Retinal Associates, PA
Asheville, North Carolina, 28803, United States
University of North Carolina
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
OSU Eye Physicians and Surgeons, LLC.
Columbus, Ohio, 43212, United States
Retina Vitreous Center
Edmond, Oklahoma, 73013, United States
Dean A. McGee Eye Institute
Oklahoma City, Oklahoma, 73104, United States
Retina Northwest, PC
Portland, Oregon, 97210, United States
Casey Eye Institute
Portland, Oregon, 97239, United States
Family Eye Group
Lancaster, Pennsylvania, 17601-2644, United States
University of Pennsylvania Scheie Eye Institute
Philadelphia, Pennsylvania, 19104, United States
Retina Vitrous Consultants
Pittsburgh, Pennsylvania, 15213, United States
Storm Eye Institute, Medical University of South Carolina
Charleston, South Carolina, 29425, 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
Southwest Retina Specialists
Amarillo, Texas, 79106, United States
Austin Retina Associates
Austin, Texas, 78705, United States
Retina Research Center
Austin, Texas, 78705, United States
Retina and Vitreous of Texas
Houston, Texas, 77025, United States
Baylor Eye Physicians and Surgeons
Houston, Texas, 77030, United States
Retina Consultants of Houston, PA
Houston, Texas, 77030, United States
Texas Retina Associates
Lubbock, Texas, 79424, United States
Valley Retina Institute
McAllen, Texas, 78503, United States
Retinal Consultants of San Antonio
San Antonio, Texas, 78240, United States
Retina Associates of Utah, P.C.
Salt Lake City, Utah, 84107, United States
Virginia Retina Center
Leesburg, Virginia, 20176, United States
Retina Institute of Virginia
Richmond, Virginia, 23235, United States
University of Washington Medical Center
Seattle, Washington, 98195, United States
Spokane Eye Clinic
Spokane, Washington, 99204, United States
University of Wisconsin-Madison, Dept of Ophthalmology/Retina Service
Madison, Wisconsin, 53705, United States
Medical College of Wiconsin
Milwaukee, Wisconsin, 53226, United States
Related Publications (22)
Wells JA, Glassman AR, Jampol LM, Aiello LP, Antoszyk AN, Baker CW, Bressler NM, Browning DJ, Connor CG, Elman MJ, Ferris FL, Friedman SM, Melia M, Pieramici DJ, Sun JK, Beck RW; Diabetic Retinopathy Clinical Research Network. Association of Baseline Visual Acuity and Retinal Thickness With 1-Year Efficacy of Aflibercept, Bevacizumab, and Ranibizumab for Diabetic Macular Edema. JAMA Ophthalmol. 2016 Feb;134(2):127-34. doi: 10.1001/jamaophthalmol.2015.4599.
PMID: 26605836BACKGROUNDWells JA, Glassman AR, Ayala AR, Jampol LM, Bressler NM, Bressler SB, Brucker AJ, Ferris FL, Hampton GR, Jhaveri C, Melia M, Beck RW; Diabetic Retinopathy Clinical Research Network. Aflibercept, Bevacizumab, or Ranibizumab for Diabetic Macular Edema: Two-Year Results from a Comparative Effectiveness Randomized Clinical Trial. Ophthalmology. 2016 Jun;123(6):1351-9. doi: 10.1016/j.ophtha.2016.02.022. Epub 2016 Feb 27.
PMID: 26935357BACKGROUNDJampol LM, Glassman AR, Bressler NM. Comparative Effectiveness Trial for Diabetic Macular Edema: Three Comparisons for the Price of 1 Study From the Diabetic Retinopathy Clinical Research Network. JAMA Ophthalmol. 2015 Sep;133(9):983-4. doi: 10.1001/jamaophthalmol.2015.1880. No abstract available.
PMID: 26087135BACKGROUNDJampol LM, Glassman AR, Bressler NM, Wells JA, Ayala AR; Diabetic Retinopathy Clinical Research Network. Anti-Vascular Endothelial Growth Factor Comparative Effectiveness Trial for Diabetic Macular Edema: Additional Efficacy Post Hoc Analyses of a Randomized Clinical Trial. JAMA Ophthalmol. 2016 Dec 1;134(12):10.1001/jamaophthalmol.2016.3698. doi: 10.1001/jamaophthalmol.2016.3698.
PMID: 27711918BACKGROUNDRoss EL, Hutton DW, Stein JD, Bressler NM, Jampol LM, Glassman AR; Diabetic Retinopathy Clinical Research Network. Cost-effectiveness of Aflibercept, Bevacizumab, and Ranibizumab for Diabetic Macular Edema Treatment: Analysis From the Diabetic Retinopathy Clinical Research Network Comparative Effectiveness Trial. JAMA Ophthalmol. 2016 Aug 1;134(8):888-96. doi: 10.1001/jamaophthalmol.2016.1669.
PMID: 27280850BACKGROUNDWells JA 3rd, Glassman AR, Jampol LM. Targeting the Effect of VEGF in Diabetic Macular Edema. N Engl J Med. 2015 Jul 30;373(5):481-2. doi: 10.1056/NEJMc1505684. No abstract available.
PMID: 26222565BACKGROUNDBressler NM, Glassman AR, Hutton DW. Controversies in Using Off-Label Intravitreous Bevacizumab for Patients With Diabetic Macular Edema-Reply. JAMA Ophthalmol. 2017 Mar 1;135(3):291-292. doi: 10.1001/jamaophthalmol.2016.5686. No abstract available.
PMID: 28152135BACKGROUNDBressler SB, Liu D, Glassman AR, Blodi BA, Castellarin AA, Jampol LM, Kaufman PL, Melia M, Singh H, Wells JA; Diabetic Retinopathy Clinical Research Network. Change in Diabetic Retinopathy Through 2 Years: Secondary Analysis of a Randomized Clinical Trial Comparing Aflibercept, Bevacizumab, and Ranibizumab. JAMA Ophthalmol. 2017 Jun 1;135(6):558-568. doi: 10.1001/jamaophthalmol.2017.0821.
PMID: 28448655BACKGROUNDBressler NM, Beaulieu WT, Glassman AR, Blinder KJ, Bressler SB, Jampol LM, Melia M, Wells JA 3rd; Diabetic Retinopathy Clinical Research Network. Persistent Macular Thickening Following Intravitreous Aflibercept, Bevacizumab, or Ranibizumab for Central-Involved Diabetic Macular Edema With Vision Impairment: A Secondary Analysis of a Randomized Clinical Trial. JAMA Ophthalmol. 2018 Mar 1;136(3):257-269. doi: 10.1001/jamaophthalmol.2017.6565.
PMID: 29392288BACKGROUNDGlassman AR, Liu D, Jampol LM, Sun JK; Diabetic Retinopathy Clinical Research Network. Changes in Blood Pressure and Urine Albumin-Creatinine Ratio in a Randomized Clinical Trial Comparing Aflibercept, Bevacizumab, and Ranibizumab for Diabetic Macular Edema. Invest Ophthalmol Vis Sci. 2018 Mar 1;59(3):1199-1205. doi: 10.1167/iovs.17-22853.
PMID: 29625440BACKGROUNDJampol LM, Glassman AR, Liu D, Aiello LP, Bressler NM, Duh EJ, Quaggin S, Wells JA, Wykoff CC; Diabetic Retinopathy Clinical Research Network. Plasma Vascular Endothelial Growth Factor Concentrations after Intravitreous Anti-Vascular Endothelial Growth Factor Therapy for Diabetic Macular Edema. Ophthalmology. 2018 Jul;125(7):1054-1063. doi: 10.1016/j.ophtha.2018.01.019. Epub 2018 Mar 7.
PMID: 29525602BACKGROUNDBressler NM, Beaulieu WT, Maguire MG, Glassman AR, Blinder KJ, Bressler SB, Gonzalez VH, Jampol LM, Melia M, Sun JK, Wells JA 3rd; Diabetic Retinopathy Clinical Research Network. Early Response to Anti-Vascular Endothelial Growth Factor and Two-Year Outcomes Among Eyes With Diabetic Macular Edema in Protocol T. Am J Ophthalmol. 2018 Nov;195:93-100. doi: 10.1016/j.ajo.2018.07.030. Epub 2018 Aug 2.
PMID: 30077569BACKGROUNDBressler SB, Odia I, Maguire MG, Dhoot DS, Glassman AR, Jampol LM, Marcus DM, Solomon SD, Sun JK; Diabetic Retinopathy Clinical Research Network. Factors Associated With Visual Acuity and Central Subfield Thickness Changes When Treating Diabetic Macular Edema With Anti-Vascular Endothelial Growth Factor Therapy: An Exploratory Analysis of the Protocol T Randomized Clinical Trial. JAMA Ophthalmol. 2019 Apr 1;137(4):382-389. doi: 10.1001/jamaophthalmol.2018.6786.
PMID: 30676635BACKGROUNDBressler NM, Odia I, Maguire M, Glassman AR, Jampol LM, MacCumber MW, Shah C, Rosberger D, Sun JK; DRCR Retina Network. Association Between Change in Visual Acuity and Change in Central Subfield Thickness During Treatment of Diabetic Macular Edema in Participants Randomized to Aflibercept, Bevacizumab, or Ranibizumab: A Post Hoc Analysis of the Protocol T Randomized Clinical Trial. JAMA Ophthalmol. 2019 Sep 1;137(9):977-985. doi: 10.1001/jamaophthalmol.2019.1963.
PMID: 31246237BACKGROUNDWells JA, Glassman AR, Ayala AR, Jampol LM. Reply. Ophthalmology. 2017 Jan;124(1):e5-e6. doi: 10.1016/j.ophtha.2016.04.032. No abstract available.
PMID: 27993277BACKGROUNDWells JA, Glassman AR, Jampol LM, Ayala A, Bressler NM. Reply. Ophthalmology. 2017 Mar;124(3):e26-e27. doi: 10.1016/j.ophtha.2016.07.001. No abstract available.
PMID: 28219510BACKGROUNDWells JA, Glassman AR, Bressler NM, Ayala AR, Jampol LM. Reply. Ophthalmology. 2017 Apr;124(4):e38-e39. doi: 10.1016/j.ophtha.2016.08.032. No abstract available.
PMID: 28335949BACKGROUNDGlassman AR, Duh EJ, Liu D, Jampol LM. Reply. Ophthalmology. 2018 Nov;125(11):e82. doi: 10.1016/j.ophtha.2018.05.004. No abstract available.
PMID: 30318048BACKGROUNDDiabetic Retinopathy Clinical Research Network; Wells JA, Glassman AR, Ayala AR, Jampol LM, Aiello LP, Antoszyk AN, Arnold-Bush B, Baker CW, Bressler NM, Browning DJ, Elman MJ, Ferris FL, Friedman SM, Melia M, Pieramici DJ, Sun JK, Beck RW. Aflibercept, bevacizumab, or ranibizumab for diabetic macular edema. N Engl J Med. 2015 Mar 26;372(13):1193-203. doi: 10.1056/NEJMoa1414264. Epub 2015 Feb 18.
PMID: 25692915RESULTTalcott 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.
PMID: 36774994DERIVEDPawloff M, Bogunovic H, Gruber A, Michl M, Riedl S, Schmidt-Erfurth U. SYSTEMATIC CORRELATION OF CENTRAL SUBFIELD THICKNESS WITH RETINAL FLUID VOLUMES QUANTIFIED BY DEEP LEARNING IN THE MAJOR EXUDATIVE MACULAR DISEASES. Retina. 2022 May 1;42(5):831-841. doi: 10.1097/IAE.0000000000003385.
PMID: 34934034DERIVEDRoberts PK, Vogl WD, Gerendas BS, Glassman AR, Bogunovic H, Jampol LM, Schmidt-Erfurth UM. Quantification of Fluid Resolution and Visual Acuity Gain in Patients With Diabetic Macular Edema Using Deep Learning: A Post Hoc Analysis of a Randomized Clinical Trial. JAMA Ophthalmol. 2020 Sep 1;138(9):945-953. doi: 10.1001/jamaophthalmol.2020.2457.
PMID: 32722799DERIVED
Results Point of Contact
- Title
- Adam Glassman
- Organization
- Jaeb Center for Health Research
Study Officials
- STUDY CHAIR
John A Wells, MD
Palmetto Retina Center
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 21, 2012
First Posted
June 25, 2012
Study Start
August 1, 2012
Primary Completion
October 1, 2014
Study Completion
April 18, 2019
Last Updated
August 10, 2020
Results First Posted
December 16, 2015
Record last verified: 2020-07