AzTrials
AzTrials

Diabetic Macular EdemaPhase 3Protocol TNCT01627249

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

A Phase 3 study testing 2.0 mg intravitreal aflibercept, 1.25 mg intravitreal bevacizumab and 0.3 mg intravitreal ranibizumab in people with Diabetic Macular Edema, run by Jaeb Center for Health Research at 90 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Diabetic Macular Edema
What is being tested?
2.0 mg intravitreal aflibercept, 1.25 mg intravitreal bevacizumab and 0.3 mg intravitreal ranibizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
660 participants
Where
90 sitesUnited States
Study dates
Aug 2012to 18 Apr 2019
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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.

Who cannot join

  • 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.
Show all 28Show fewer
  • 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.

Trial locations and contacts

90 sites in 1 country.

90 sites in 1 country

United States90 sites

  • Eye Associates of New Mexico

    Albuquerque, New Mexico, 87102

  • University of New Mexico Health Sciences Center

    Albuquerque, New Mexico, 871310001

  • Southwest Retina Specialists

    Amarillo, Texas, 79106

  • Western Carolina Retinal Associates, PA

    Asheville, North Carolina, 28803

  • Emory Eye Center

    Atlanta, Georgia, 30322

  • Georgia Retina, P.C.

    Atlanta, Georgia, 30342

  • Thomas Eye Group

    Atlanta, Georgia, 30342

  • Southeast Retina Center, P.C.

    Augusta, Georgia, 30909

  • Austin Retina Associates

    Austin, Texas, 78705

  • Retina Research Center

    Austin, Texas, 78705

  • Elman Retina Group, P.A.

    Baltimore, Maryland, 21237

  • Wilmer Eye Institute at Johns Hopkins

    Baltimore, Maryland, 21287-9277

  • Retina Associates of Cleveland, Inc.

    Beachwood, Ohio, 44122

  • Retina-Vitreous Associates Medical Group

    Beverly Hills, California, 90211

  • Ophthalmic Consultants of Boston

    Boston, Massachusetts, 02114

  • Joslin Diabetes Center

    Boston, Massachusetts, 02215

  • University of North Carolina

    Chapel Hill, North Carolina, 27599-7040

  • Storm Eye Institute, Medical University of South Carolina

    Charleston, South Carolina, 29425

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

    Charlotte, North Carolina, 28210

  • Northwestern Medical Faculty Foundation

    Chicago, Illinois, 60611

  • University of Illinois at Chicago Medical Center

    Chicago, Illinois, 60612

  • Gulf Coast Retina Center

    Clearwater, Florida, 33761

  • Case Western Reserve University

    Cleveland, Ohio, 44106

  • Palmetto Retina Center

    Columbia, South Carolina, 29169

  • Carolina Retina Center

    Columbia, South Carolina, 29223

  • OSU Eye Physicians and Surgeons, LLC.

    Columbus, Ohio, 43212

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

    Detroit, Michigan, 48202

  • Medical Associates Clinic, P.C.

    Dubuque, Iowa, 52002

  • Retina Vitreous Center

    Edmond, Oklahoma, 73013

  • Retina Group of Florida

    Fort Lauderdale, Florida, 33334

  • National Ophthalmic Research Institute

    Fort Myers, Florida, 33912

  • NorthShore University HealthSystem

    Glenview, Illinois, 60026

  • Retina Vitrous Center

    Grand Blanc, Michigan, 48439

  • Retina Specialists of Michigan

    Grand Rapids, Michigan, 49525

  • Vitreo-Retinal Associates

    Grand Rapids, Michigan, 49525

  • Retina Consultants of Hawaii, Inc.

    Honolulu, Hawaii, 96701

  • Retina and Vitreous of Texas

    Houston, Texas, 77025

  • Baylor Eye Physicians and Surgeons

    Houston, Texas, 77030

  • Retina Consultants of Houston, PA

    Houston, Texas, 77030

  • Raj K. Maturi, M.D., P.C.

    Indianapolis, Indiana, 46280

  • Southeastern Retina Associates, PC

    Kingsport, Tennessee, 37660

  • Southeastern Retina Associates, P.C.

    Knoxville, Tennessee, 37909

  • Central Florida Retina Institute

    Lakeland, Florida, 33805

  • Family Eye Group

    Lancaster, Pennsylvania, 17601-2644

  • Virginia Retina Center

    Leesburg, Virginia, 20176

  • Retina and Vitreous Associates of Kentucky

    Lexington, Kentucky, 40509-1802

  • Loma Linda University Health Care, Dept. of Ophthalmology

    Loma Linda, California, 92354

  • Texas Retina Associates

    Lubbock, Texas, 79424

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

    Madison, Wisconsin, 53705

  • Valley Retina Institute

    McAllen, Texas, 78503

  • Medical College of Wiconsin

    Milwaukee, Wisconsin, 53226

  • Retina Center, PA

    Minneapolis, Minnesota, 55404

  • John-Kenyon American Eye Institute

    New Albany, Indiana, 47150

  • The New York Eye and Ear Infirmary/Faculty Eye Practice

    New York, New York, 10003

  • MaculaCare

    New York, New York, 10021

  • Mount Sinai School of Medicine, Dept. of Ophthalmology

    New York, New York, 10029

  • The Institute of Ophthalmology and Visual Science (IOVS)

    Newark, New Jersey, 07103

  • New England Retina Associates

    Norwich, Connecticut, 06360

  • Ocala Eye Retina Consultants

    Ocala, Florida, 34474

  • Dean A. McGee Eye Institute

    Oklahoma City, Oklahoma, 73104

  • Magruder Eye Institute

    Orlando, Florida, 32803

  • Paducah Retinal Center

    Paducah, Kentucky, 42001

  • Southern California Desert Retina Consultants, MC

    Palm Desert, California, 92211

  • University of Pennsylvania Scheie Eye Institute

    Philadelphia, Pennsylvania, 19104

  • Retina Vitrous Consultants

    Pittsburgh, Pennsylvania, 15213

  • Fort Lauderdale Eye Institute

    Plantation, Florida, 33324

  • Retina Northwest, PC

    Portland, Oregon, 97210

  • Casey Eye Institute

    Portland, Oregon, 97239

  • Eyesight Ophthalmic Services, PA

    Portsmouth, New Hampshire, 03801

  • Retina Institute of Virginia

    Richmond, Virginia, 23235

  • Mayo Clinic Department of Ophthalmology

    Rochester, Minnesota, 55905

  • Retina Associates of Western New York

    Rochester, New York, 14618

  • University of Rochester

    Rochester, New York, 14642

  • Retina Associates of Utah, P.C.

    Salt Lake City, Utah, 84107

  • Retinal Consultants of San Antonio

    San Antonio, Texas, 78240

  • California Retina Consultants

    Santa Barbara, California, 93103

  • Sarasota Retina Institute

    Sarasota, Florida, 34239

  • University of Washington Medical Center

    Seattle, Washington, 98195

  • Retina Associates, P.A.

    Shawnee Mission, Kansas, 66204

  • Spokane Eye Clinic

    Spokane, Washington, 99204

  • Barnes Retina Institute

    St Louis, Missouri, 63110

  • Retina-Vitreous Surgeons of Central New York, PC

    Syracuse, New York, 13224

  • Retina Associates of Florida, P.A.

    Tampa, Florida, 33609

  • Montefiore Medical Center

    The Bronx, New York, 10467-2401

  • Retina Associates

    Tucson, Arizona, 85710

  • Bay Area Retina Associates

    Walnut Creek, California, 94598

  • Wolfe Eye Clinic

    West Des Moines, Iowa, 50266

  • Retinal Consultants of Southern California Medical Group, Inc.

    Westlake Village, California, 91361

  • Wake Forest University Eye Center

    Winston-Salem, North Carolina, 27157

  • Vitreo-Retinal Associates, PC

    Worcester, Massachusetts, 01605

Other trials in United States

About this study

Official title: A Comparative Effectiveness Study of Intravitreal Aflibercept, Bevacizumab and Ranibizumab for Diabetic Macular Edema

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.

Read the detailed description

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

Being tested
2.0 mg intravitreal aflibercept, 1.25 mg intravitreal bevacizumab, 0.3 mg intravitreal ranibizumab
Keywords
Diabetic Macular Edema, anti-vascular endothelial growth factor

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 2.0 mg intravitreal afliberceptDrug

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

  • 1.25 mg intravitreal bevacizumabDrug

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

  • 0.3 mg intravitreal ranibizumabDrug

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

Study groups in NCT01627249
Study groupRoleWhat they receive
RanibizumabActive comparatorNot described
Receives: Drug: 0.3 mg intravitreal ranibizumab
AfliberceptExperimentalNot described
Receives: Drug: 2.0 mg intravitreal aflibercept
BevacizumabExperimentalNot described
Receives: Drug: 1.25 mg intravitreal bevacizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline to 1-year

  2. 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.

    Measured: Baseline to 1-year

  3. 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.

    Measured: Baseline to 1-year

Secondary outcomes (7)

  1. Overall Change in Optical Coherence Tomography Central Subfield Thickness

    All baseline and 1-year optical coherence tomography (OCT) scans were graded by Duke Reading Center. In addition, a random sample of OCT images from other visits and images for which the investigator believed central grading was needed also were graded by Duke Reading Center.

    Baseline CSF values were converted from the thickness value measured on a Spectralis or Cirrus OCT machine to a Stratus equivalent value for 583 scans. One-year CSF values were converted from a thickness value measured on a Spectralis or Cirrus OCT machine to a Stratus equivalent value for 604 scans. When calculating change in CSF thickness, measurements taken on the same machine at both visits were not converted, since the conversion equation slope is nearly 1 and the constant difference does not affect the change calculation. Therefore, change in CSF thickness was calculated after converting either the baseline and/or follow-up thickness value from Spectralis or Cirrus to a Stratus equivalent value in 26 eyes.

    Measured: baseline to 1-year

  2. Change in Optical Coherence Tomography Central Subfield Thickness: Baseline Visual Acuity Letter Score <69

    All baseline and 1-year optical coherence tomography (OCT) scans were graded by Duke Reading Center. In addition, a random sample of OCT images from other visits and images for which the investigator believed central grading was needed also were graded by Duke Reading Center.

    Baseline CSF values were converted from the thickness value measured on a Spectralis or Cirrus OCT machine to a Stratus equivalent value for 583 scans. One-year CSF values were converted from a thickness value measured on a Spectralis or Cirrus OCT machine to a Stratus equivalent value for 604 scans. When calculating change in CSF thickness, measurements taken on the same machine at both visits were not converted, since the conversion equation slope is nearly 1 and the constant difference does not affect the change calculation. Therefore, change in CSF thickness was calculated after converting either the baseline and/or follow-up thickness value from Spectralis or Cirrus to a Stratus equivalent value in 26 eyes.

    Measured: baseline to 1-year

  3. Change in Optical Coherence Tomography Central Subfield Thickness: Baseline Visual Acuity Letter Score 78-69

    All baseline and 1-year optical coherence tomography (OCT) scans were graded by Duke Reading Center. In addition, a random sample of OCT images from other visits and images for which the investigator believed central grading was needed also were graded by Duke Reading Center.

    Baseline CSF values were converted from the thickness value measured on a Spectralis or Cirrus OCT machine to a Stratus equivalent value for 583 scans. One-year CSF values were converted from a thickness value measured on a Spectralis or Cirrus OCT machine to a Stratus equivalent value for 604 scans. When calculating change in CSF thickness, measurements taken on the same machine at both visits were not converted, since the conversion equation slope is nearly 1 and the constant difference does not affect the change calculation. Therefore, change in CSF thickness was calculated after converting either the baseline and/or follow-up thickness value from Spectralis or Cirrus to a Stratus equivalent value in 26 eyes.

    Measured: baseline to 1-year

  4. Overall Change in Retinal Volume

    Baseline volume values were converted from the thickness value measured on a Spectralis or Cirrus OCT machine to a Stratus equivalent value for 459 scans. One-year volume values were converted from a thickness value measured on a Spectralis or Cirrus OCT machine to a Stratus equivalent value for 472 scans. When calculating change in volume, measurements taken on the same machine at both visits were not converted, because the conversion equation slope is nearly 1 and the constant difference does not affect the change calculation. Therefore, change in volume was calculated after converting either the baseline and/or follow-up value from Spectralis or Cirrus to a Stratus equivalent value in 17 eyes.

    Measured: Baseline to 1-year

  5. Total Number of Injections Prior to 1 Year

    Only includes participants that completed the 1 year visit

    Measured: Baseline to 1-year

  6. Total Number of Laser Treatments

    Only includes participants that completed the 1 year visit.

    Measured: between 24 weeks and 1 year

  7. Eyes Receiving 1 or More Alternative Treatments for DME Other Than Laser

    Measured: Baseline to 1-year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Jun 2012 (estimated)
  2. Study startAug 2012
  3. Primary completionOct 2014
  4. Study completion18 Apr 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
660 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01627249
Sponsor's protocol ID
DRCR.net Protocol T
Other IDs
EY14231, EY23207, EY18817
Acronym
Protocol T
Status last verified
Jul 2020
First submitted
21 Jun 2012
Last updated
10 Aug 2020
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 26605836

  • 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.

    PubMed 26935357

  • 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.

    PubMed 26087135

  • 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.

    PubMed 27711918

  • 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.

    PubMed 27280850

  • 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.

    PubMed 26222565

  • 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.

    PubMed 28152135

  • 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.

    PubMed 28448655

  • 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.

    PubMed 29392288

  • 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.

    PubMed 29625440

  • 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.

    PubMed 29525602

  • 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.

    PubMed 30077569

  • 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.

    PubMed 30676635

  • 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.

    PubMed 31246237

  • 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.

    PubMed 27993277

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing 2.0 mg intravitreal aflibercept, 1.25 mg intravitreal bevacizumab and 0.3 mg intravitreal ranibizumab in people with Diabetic Macular Edema, run by Jaeb Center for Health Research at 90 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 90 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Dec 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Change in Electronic Early Treatment Diabetic Retinopathy Study Visual Acuity Letter Score From Baseline to 1-year (time frame: Baseline to 1-year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01627249, which also lists 22 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2020.

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