Comparative Effectiveness Study of Intravitreal Aflibercept, Bevacizumab, and Ranibizumab for Diabetic Macular Edema

NCT ID: NCT01627249

Last Updated: 2020-08-10

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

660 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-08-31

Study Completion Date

2019-04-18

Brief Summary

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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.

Detailed Description

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A five year follow-up visit is being conducted to gather information on long term outcomes

Conditions

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Diabetic Macular Edema

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Ranibizumab

Group Type ACTIVE_COMPARATOR

0.3 mg intravitreal ranibizumab

Intervention Type DRUG

Intravitreal injection of 0.3 mg ranibizumab (Lucentis™) at baseline and up to every 4 weeks using defined retreatment criteria.

Aflibercept

Group Type EXPERIMENTAL

2.0 mg intravitreal aflibercept

Intervention Type DRUG

Intravitreal injection of 2.0 mg aflibercept at baseline and up to every 4 weeks using defined retreatment criteria.

Bevacizumab

Group Type EXPERIMENTAL

1.25 mg intravitreal bevacizumab

Intervention Type DRUG

Intravitreal injection of 1.25 mg bevacizumab at baseline and up to every 4 weeks using defined retreatment criteria.

Interventions

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2.0 mg intravitreal aflibercept

Intravitreal injection of 2.0 mg aflibercept at baseline and up to every 4 weeks using defined retreatment criteria.

Intervention Type DRUG

1.25 mg intravitreal bevacizumab

Intravitreal injection of 1.25 mg bevacizumab at baseline and up to every 4 weeks using defined retreatment criteria.

Intervention Type DRUG

0.3 mg intravitreal ranibizumab

Intravitreal injection of 0.3 mg ranibizumab (Lucentis™) at baseline and up to every 4 weeks using defined retreatment criteria.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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.

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 eye should not be considered eligible if: (1) the macular edema is considered to be related to ocular surgery such as cataract extraction or (2) clinical exam and/or OCT suggest that vitreoretinal interface abnormalities (e.g., a taut posterior hyaloid or epiretinal membrane) are the primary cause of the 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 three lines or more (i.e., cataract would be reducing acuity to 20/40 or worse if eye was otherwise normal).
* History of an anti-VEGF treatment for DME in the past 12 months or history of any other treatment for DME at any time in the past four months (such as focal/grid macular photocoagulation, intravitreal or peribulbar corticosteroids).
* Enrollment will be limited to a maximum of 25% of the planned sample size with any history of anti-VEGF treatment for DME. Once this number of eyes has been enrolled, any history of anti-VEGF treatment for DME will be an exclusion criterion.
* History of pan-retinal photocoagulation within four months prior to randomization or anticipated need for pan-retinal photocoagulation in the six months following randomization.
* History of anti-VEGF treatment for a disease other than DME in the past 12 months.
* History of major ocular surgery (including vitrectomy, cataract extraction, scleral buckle, any intraocular surgery, etc.) within prior four months or anticipated within the next six months following randomization.
* History of YAG capsulotomy performed within two months prior to randomization.
* Aphakia.
* Exam evidence of external ocular infection, including conjunctivitis, chalazion, or significant blepharitis.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Eye Institute (NEI)

NIH

Sponsor Role collaborator

Genentech, Inc.

INDUSTRY

Sponsor Role collaborator

Regeneron Pharmaceuticals

INDUSTRY

Sponsor Role collaborator

Jaeb Center for Health Research

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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John A Wells, MD

Role: STUDY_CHAIR

Palmetto Retina Center

Locations

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Retina Associates

Tucson, Arizona, United States

Site Status

Retina-Vitreous Associates Medical Group

Beverly Hills, California, United States

Site Status

Loma Linda University Health Care, Dept. of Ophthalmology

Loma Linda, California, United States

Site Status

Southern California Desert Retina Consultants, MC

Palm Desert, California, United States

Site Status

California Retina Consultants

Santa Barbara, California, United States

Site Status

Bay Area Retina Associates

Walnut Creek, California, United States

Site Status

Retinal Consultants of Southern California Medical Group, Inc.

Westlake Village, California, United States

Site Status

New England Retina Associates

Norwich, Connecticut, United States

Site Status

Gulf Coast Retina Center

Clearwater, Florida, United States

Site Status

Retina Group of Florida

Fort Lauderdale, Florida, United States

Site Status

National Ophthalmic Research Institute

Fort Myers, Florida, United States

Site Status

Central Florida Retina Institute

Lakeland, Florida, United States

Site Status

Ocala Eye Retina Consultants

Ocala, Florida, United States

Site Status

Magruder Eye Institute

Orlando, Florida, United States

Site Status

Fort Lauderdale Eye Institute

Plantation, Florida, United States

Site Status

Sarasota Retina Institute

Sarasota, Florida, United States

Site Status

Retina Associates of Florida, P.A.

Tampa, Florida, United States

Site Status

Emory Eye Center

Atlanta, Georgia, United States

Site Status

Georgia Retina, P.C.

Atlanta, Georgia, United States

Site Status

Thomas Eye Group

Atlanta, Georgia, United States

Site Status

Southeast Retina Center, P.C.

Augusta, Georgia, United States

Site Status

Retina Consultants of Hawaii, Inc.

Honolulu, Hawaii, United States

Site Status

Northwestern Medical Faculty Foundation

Chicago, Illinois, United States

Site Status

University of Illinois at Chicago Medical Center

Chicago, Illinois, United States

Site Status

NorthShore University HealthSystem

Glenview, Illinois, United States

Site Status

Raj K. Maturi, M.D., P.C.

Indianapolis, Indiana, United States

Site Status

John-Kenyon American Eye Institute

New Albany, Indiana, United States

Site Status

Medical Associates Clinic, P.C.

Dubuque, Iowa, United States

Site Status

Wolfe Eye Clinic

West Des Moines, Iowa, United States

Site Status

Retina Associates, P.A.

Shawnee Mission, Kansas, United States

Site Status

Retina and Vitreous Associates of Kentucky

Lexington, Kentucky, United States

Site Status

Paducah Retinal Center

Paducah, Kentucky, United States

Site Status

Elman Retina Group, P.A.

Baltimore, Maryland, United States

Site Status

Wilmer Eye Institute at Johns Hopkins

Baltimore, Maryland, United States

Site Status

Ophthalmic Consultants of Boston

Boston, Massachusetts, United States

Site Status

Joslin Diabetes Center

Boston, Massachusetts, United States

Site Status

Vitreo-Retinal Associates, PC

Worcester, Massachusetts, United States

Site Status

Henry Ford Health System, Dept of Ophthalmology and Eye Care Services

Detroit, Michigan, United States

Site Status

Retina Vitrous Center

Grand Blanc, Michigan, United States

Site Status

Retina Specialists of Michigan

Grand Rapids, Michigan, United States

Site Status

Vitreo-Retinal Associates

Grand Rapids, Michigan, United States

Site Status

Retina Center, PA

Minneapolis, Minnesota, United States

Site Status

Mayo Clinic Department of Ophthalmology

Rochester, Minnesota, United States

Site Status

Barnes Retina Institute

St Louis, Missouri, United States

Site Status

Eyesight Ophthalmic Services, PA

Portsmouth, New Hampshire, United States

Site Status

The Institute of Ophthalmology and Visual Science (IOVS)

Newark, New Jersey, United States

Site Status

Eye Associates of New Mexico

Albuquerque, New Mexico, United States

Site Status

University of New Mexico Health Sciences Center

Albuquerque, New Mexico, United States

Site Status

The New York Eye and Ear Infirmary/Faculty Eye Practice

New York, New York, United States

Site Status

MaculaCare

New York, New York, United States

Site Status

Mount Sinai School of Medicine, Dept. of Ophthalmology

New York, New York, United States

Site Status

Retina Associates of Western New York

Rochester, New York, United States

Site Status

University of Rochester

Rochester, New York, United States

Site Status

Retina-Vitreous Surgeons of Central New York, PC

Syracuse, New York, United States

Site Status

Montefiore Medical Center

The Bronx, New York, United States

Site Status

Western Carolina Retinal Associates, PA

Asheville, North Carolina, United States

Site Status

University of North Carolina

Chapel Hill, North Carolina, United States

Site Status

Charlotte Eye, Ear, Nose and Throat Assoc., PA

Charlotte, North Carolina, United States

Site Status

Wake Forest University Eye Center

Winston-Salem, North Carolina, United States

Site Status

Retina Associates of Cleveland, Inc.

Beachwood, Ohio, United States

Site Status

Case Western Reserve University

Cleveland, Ohio, United States

Site Status

OSU Eye Physicians and Surgeons, LLC.

Columbus, Ohio, United States

Site Status

Retina Vitreous Center

Edmond, Oklahoma, United States

Site Status

Dean A. McGee Eye Institute

Oklahoma City, Oklahoma, United States

Site Status

Retina Northwest, PC

Portland, Oregon, United States

Site Status

Casey Eye Institute

Portland, Oregon, United States

Site Status

Family Eye Group

Lancaster, Pennsylvania, United States

Site Status

University of Pennsylvania Scheie Eye Institute

Philadelphia, Pennsylvania, United States

Site Status

Retina Vitrous Consultants

Pittsburgh, Pennsylvania, United States

Site Status

Storm Eye Institute, Medical University of South Carolina

Charleston, South Carolina, United States

Site Status

Palmetto Retina Center

Columbia, South Carolina, United States

Site Status

Carolina Retina Center

Columbia, South Carolina, United States

Site Status

Southeastern Retina Associates, PC

Kingsport, Tennessee, United States

Site Status

Southeastern Retina Associates, P.C.

Knoxville, Tennessee, United States

Site Status

Southwest Retina Specialists

Amarillo, Texas, United States

Site Status

Austin Retina Associates

Austin, Texas, United States

Site Status

Retina Research Center

Austin, Texas, United States

Site Status

Retina and Vitreous of Texas

Houston, Texas, United States

Site Status

Baylor Eye Physicians and Surgeons

Houston, Texas, United States

Site Status

Retina Consultants of Houston, PA

Houston, Texas, United States

Site Status

Texas Retina Associates

Lubbock, Texas, United States

Site Status

Valley Retina Institute

McAllen, Texas, United States

Site Status

Retinal Consultants of San Antonio

San Antonio, Texas, United States

Site Status

Retina Associates of Utah, P.C.

Salt Lake City, Utah, United States

Site Status

Virginia Retina Center

Leesburg, Virginia, United States

Site Status

Retina Institute of Virginia

Richmond, Virginia, United States

Site Status

University of Washington Medical Center

Seattle, Washington, United States

Site Status

Spokane Eye Clinic

Spokane, Washington, United States

Site Status

University of Wisconsin-Madison, Dept of Ophthalmology/Retina Service

Madison, Wisconsin, United States

Site Status

Medical College of Wiconsin

Milwaukee, Wisconsin, United States

Site Status

Countries

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United States

References

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Jampol 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.

Reference Type BACKGROUND
PMID: 29525602 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26605836 (View on PubMed)

Wells 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.

Reference Type BACKGROUND
PMID: 26935357 (View on PubMed)

Jampol 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.

Reference Type BACKGROUND
PMID: 26087135 (View on PubMed)

Jampol 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.

Reference Type BACKGROUND
PMID: 27711918 (View on PubMed)

Ross 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.

Reference Type BACKGROUND
PMID: 27280850 (View on PubMed)

Wells 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.

Reference Type BACKGROUND
PMID: 26222565 (View on PubMed)

Bressler 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.

Reference Type BACKGROUND
PMID: 28152135 (View on PubMed)

Bressler 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.

Reference Type BACKGROUND
PMID: 28448655 (View on PubMed)

Bressler 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.

Reference Type BACKGROUND
PMID: 29392288 (View on PubMed)

Glassman 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.

Reference Type BACKGROUND
PMID: 29625440 (View on PubMed)

Bressler 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.

Reference Type BACKGROUND
PMID: 30077569 (View on PubMed)

Bressler 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.

Reference Type BACKGROUND
PMID: 30676635 (View on PubMed)

Bressler 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.

Reference Type BACKGROUND
PMID: 31246237 (View on PubMed)

Wells 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.

Reference Type BACKGROUND
PMID: 27993277 (View on PubMed)

Wells 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.

Reference Type BACKGROUND
PMID: 28219510 (View on PubMed)

Wells 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.

Reference Type BACKGROUND
PMID: 28335949 (View on PubMed)

Glassman 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.

Reference Type BACKGROUND
PMID: 30318048 (View on PubMed)

Diabetic 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.

Reference Type RESULT
PMID: 25692915 (View on PubMed)

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.

Reference Type DERIVED
PMID: 36774994 (View on PubMed)

Pawloff 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.

Reference Type DERIVED
PMID: 34934034 (View on PubMed)

Roberts 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.

Reference Type DERIVED
PMID: 32722799 (View on PubMed)

Other Identifiers

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EY14231

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

EY23207

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

EY18817

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

DRCR.net Protocol T

Identifier Type: -

Identifier Source: org_study_id

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