Treatment for CI-DME in Eyes With Very Good VA Study (Protocol V)

Treatment for Central-Involved Diabetic Macular Edema in Eyes With Very Good Visual Acuity

Although multiple studies have clearly demonstrated that ranibizumab therapy is more effective than laser alone for vision gain and avoiding vision loss in patients with central-involved Diabetic Macular Edema (DME), only eyes with poor visual acuity, such as a visual acuity letter score of 78 or worse (approximate Snellen equivalent of 20/32 or worse) were eligible. Eyes that have central-involved DME with "good" visual acuity (20/25 or better) have not been addressed systematically by recent studies for treatment of DME. Baseline cohort characteristics from the Early Treatment Diabetic Retinopathy Study (ETDRS) suggest that a substantial percentage of eyes with central-involved DME may retain good vision. The investigators do not know definitively whether eyes with central-involved DME and good vision do better with anti-VEGF (vascular endothelial growth factor) (e.g. aflibercept) therapy initially, or focal/grid laser treatment or observation initially followed by anti-VEGF only if vision worsens.

The primary objective of the protocol is to compare the % of eyes that have lost at least 5 letters of visual acuity at 2 years compared with baseline mean visual acuity in eyes with central-involved DME and good visual acuity defined as a Snellen equivalent of 20/25 or better (electronic-ETDRS letter score of 79 or better) that receive (1) prompt focal/grid photocoagulation + deferred anti-VEGF, (2) observation + deferred anti-VEGF, or (3) prompt anti-VEGF.

Secondary objectives include:

• Comparing other visual acuity outcomes between treatment groups, such as the percent of eyes with at least 5, 10 and 15 letter losses in visual acuity from baseline mean visual acuity, percent of eyes with at least 5 letter gain in visual acuity from baseline, mean visual acuity, mean change in visual acuity, adjusted for baseline mean visual acuity
• For eyes randomized to deferred anti-VEGF, the percentage of eyes needing anti-VEGF treatment
• Comparing optical coherence tomography (OCT) outcomes, such as the mean change in OCT central subfield (CSF) thickness, adjusted for baseline mean thickness
• Comparing the number of eyes with PDR at randomization, proportion of eyes avoiding vitreous hemorrhage or panretinal photocoagulation (PRP) or vitrectomy for PDR between treatment groups
• Comparing safety outcomes between treatment groups
• Comparing associated treatment and follow-up exam costs between treatment groups

Study Overview

• Status: Completed
• Conditions: Diabetic Macular Edema
• Intervention / Treatment: Procedure: Prompt Laser; Drug: Deferred aflibercept; Procedure: Deferred laser; Drug: Prompt aflibercept

• Study Type: Interventional
• Enrollment (Actual): 702
• Phase: Phase 3

Contacts and Locations

Study Locations

• Canada
  • Vancouver, Canada, V5Z 3N9
    • UBC/VCHA Eye Care Centre
  • Alberta
    • Edmonton, Alberta, Canada, T5H 0X5
      • Alberta Retina Consultants
  • Ontario
    • Toronto, Ontario, Canada, M5T 258
      • University Health Network - Toronto Western Hospital
• United States
  • Arizona
    • Phoenix, Arizona, United States, 85021
      • Arizona Retina and Vitreous Consultants
    • Tucson, Arizona, United States, 85711
      • University of Arizona Medical Center/Department of Ophthalmology
  • Arkansas
    • Little Rock, Arkansas, United States, 72205-7199
      • Jones Eye Institute/University of Arkansas for Medical Sciences
  • California
    • Campbell, California, United States, 95008
      • Retinal Diagnostic Center
    • Loma Linda, California, United States, 92354
      • Loma Linda University Health Care, Dept. of Ophthalmology
    • Long Beach, California, United States, 90807
      • South Coast Retina Center
    • Palm Desert, California, United States, 92211
      • Southern California Desert Retina Consultants, MC
    • Redlands, California, United States, 92374
      • Retina Consultants of Southern California
    • Sacramento, California, United States, 95841
      • Retinal Consultants Medical Group, Inc.
    • Santa Barbara, California, United States, 93103
      • California Retina Consultants
    • Walnut Creek, California, United States, 94598
      • Bay Area Retina Associates
    • Westlake Village, California, United States, 91361
      • Retinal Consultants of Southern California Medical Group, Inc.
  • Connecticut
    • New London, Connecticut, United States, 06320
      • Retina Group of New England
    • Norwich, Connecticut, United States, 06360
      • New England Retina Associates
  • Florida
    • Fort Myers, Florida, United States, 33912
      • National Ophthalmic Research Institute
    • Jacksonville, Florida, United States, 32209
      • University of Florida College of Med., Department of Ophthalmology
    • Lakeland, Florida, United States, 33805
      • Florida Retina Consultants
    • Miami, Florida, United States, 33136
      • Bascom Palmer Eye Institute
    • Miami, Florida, United States, 33126
      • Retina Macula Specialists Of Miami
    • Ocala, Florida, United States, 34474
      • Ocala Eye Retina Consultants
    • Orlando, Florida, United States, 32803
      • Magruder Eye Institute
    • Plantation, Florida, United States, 33324
      • Fort Lauderdale Eye Institute
    • Sarasota, Florida, United States, 34239
      • Center for Sight
    • Sarasota, Florida, United States, 34239
      • Sarasota Retina Institute
    • Tampa, Florida, United States, 33609
      • Retina Associates of Florida, P.A.
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Emory Eye Center
    • Augusta, Georgia, United States, 30909
      • Southeast Retina Center, P.C.
    • Marietta, Georgia, United States, 30060
      • Marietta Eye Clinic
    • Sandy Springs, Georgia, United States, 30328
      • Thomas Eye Group
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern Medical Faculty Foundation
    • Chicago, Illinois, United States, 60612
      • University of Illinois at Chicago Medical Center
    • Glenview, Illinois, United States, 60026
      • Northshore University Healthsystem
    • Joliet, Illinois, United States, 60435
      • Illinois Retina Associates
    • Oak Forest, Illinois, United States, 60452
      • University Retina and Macula Associates
    • Urbana, Illinois, United States, 61801
      • Carle Foundation Hospital
  • Indiana
    • Indianapolis, Indiana, United States, 46290
      • Raj Maturi
    • New Albany, Indiana, United States, 47150
      • John-Kenyon American Eye Institute
  • Iowa
    • Dubuque, Iowa, United States, 52002
      • Medical Associates Clinic, P.C.
    • West Des Moines, Iowa, United States, 50266
      • Wolfe Eye Clinic
  • Kansas
    • Prairie Village, Kansas, United States, 66208
      • University of Kansas Medical Center, Dept. of Ophthalmology
    • Shawnee Mission, Kansas, United States, 66204
      • Retina Associates, P.A.
  • Kentucky
    • Lexington, Kentucky, United States, 40509
      • Retina and Vitreous Associates of Kentucky
    • Paducah, Kentucky, United States, 42001
      • Paducah Retinal Center
  • Maryland
    • Baltimore, Maryland, United States, 21237
      • Elman Retina Group, P.A.
    • Baltimore, Maryland, United States, 21287-9277
      • Wilmer Eye Institute at Johns Hopkins
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Joslin Diabetes Center
    • Worcester, Massachusetts, United States, 01605
      • Vitreo-Retinal Associates, PC
  • Michigan
    • Ann Arbor, Michigan, United States, 48105
      • Kellogg Eye Center, University of Michigan
    • Detroit, Michigan, United States, 48202
      • Henry Ford Health System, Dept of Ophthalmology and Eye Care Services
    • Grand Blanc, Michigan, United States, 48439
      • Retina Vitreous Center
    • Grand Rapids, Michigan, United States, 49546
      • Vitreo-Retinal Associates
    • Grand Rapids, Michigan, United States, 49525
      • Retina Specialists Of Michigan
    • Saginaw, Michigan, United States, 48603
      • Andersen Eye Associates
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • University of Minnesota
    • Minneapolis, Minnesota, United States, 55404
      • Retina Center, PA
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic Department of Ophthalmology
  • Missouri
    • Kansas City, Missouri, United States, 64111
      • Mid-America Retina Consultants, P.A.
    • Saint Louis, Missouri, United States, 63128
      • The Retina Institute
  • New Hampshire
    • Portsmouth, New Hampshire, United States, 03801
      • Eyesight Ophthalmic Services, PA
  • New Jersey
    • Newark, New Jersey, United States, 07103
      • The Institute of Ophthalmology and Visual Science (IOVS)
    • Northfield, New Jersey, United States, 08225
      • Retinal and Ophthalmic Consultants, PC
  • New Mexico
    • Albuquerque, New Mexico, United States, 87102
      • Eye Associates of New Mexico
  • New York
    • Buffalo, New York, United States, 14209
      • Ross Eye Institute, SUNY Buffalo
    • New York, New York, United States, 10003
      • The New York Eye and Ear Infirmary/Faculty Eye Practice
    • New York, New York, United States, 10021
      • MaculaCare
    • Rochester, New York, United States, 14642
      • University of Rochester
    • Rochester, New York, United States, 14618
      • Retina Associates of Western New York
    • Syracuse, New York, United States, 13224
      • Retina-Vitreous Surgeons of Central New York, PC
  • North Carolina
    • Asheville, North Carolina, United States, 28803
      • Western Carolina Retinal Associates, PA
    • Chapel Hill, North Carolina, United States, 27599-7040
      • University of North Carolina
    • Charlotte, North Carolina, United States, 28210
      • Charlotte Eye, Ear, Nose and Throat Assoc., PA
  • Ohio
    • Beachwood, Ohio, United States, 44122
      • Retina Associates of Cleveland, Inc.
    • Cleveland, Ohio, United States, 44106
      • Case Western Reserve University
  • Oklahoma
    • Edmond, Oklahoma, United States, 73013
      • Retina Vitreous Center
  • Oregon
    • Eugene, Oregon, United States, 97401
      • Oregon Retina, LLP
    • Portland, Oregon, United States, 97239
      • Casey Eye Institute
    • Portland, Oregon, United States, 97210
      • Retina Northwest, PC
  • Pennsylvania
    • Lancaster, Pennsylvania, United States, 17601-2644
      • Family Eye Group
    • Monroeville, Pennsylvania, United States, 15146
      • Retina Vitreous Consultants
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania Scheie Eye Institute
  • South Carolina
    • Columbia, South Carolina, United States, 29223
      • Carolina Retina Center
    • West Columbia, South Carolina, United States, 29169
      • Palmetto Retina Center
  • Tennessee
    • Chattanooga, Tennessee, United States, 37421
      • Southeastern Retina Associates
    • Kingsport, Tennessee, United States, 37660
      • Southeastern Retina Associates, PC
    • Knoxville, Tennessee, United States, 37909
      • Southeastern Retina Associates, P.C.
  • Texas
    • Amarillo, Texas, United States, 79106
      • Southwest Retina Specialists
    • Austin, Texas, United States, 78705
      • Austin Retina Associates
    • Austin, Texas, United States, 78705
      • Retina Research Center
    • Houston, Texas, United States, 77030
      • Retina Consultants of Houston, PA
    • Houston, Texas, United States, 77025
      • Retina and Vitreous of Texas
    • Houston, Texas, United States, 77030
      • Baylor Eye Physicians and Surgeons
    • Lubbock, Texas, United States, 79424
      • Texas Retina Associates
    • McAllen, Texas, United States, 78503
      • Valley Retina Institute
    • San Antonio, Texas, United States, 78240
      • Retinal Consultants of San Antonio
  • Utah
    • Salt Lake City, Utah, United States, 84107
      • Retina Associates of Utah, P.C.
  • Virginia
    • Richmond, Virginia, United States, 23235
      • Retina Institute of Virginia
    • Richmond, Virginia, United States, 23298
      • Virginia Commonwealth University, Dept. of Ophthalmology
  • Washington
    • Seattle, Washington, United States, 98104
      • University of Washington Medical Center
    • Spokane, Washington, United States, 99204
      • Spokane Eye Clinic
  • Wisconsin
    • Madison, Wisconsin, United States, 53705
      • University of Wisconsin-Madison, Dept of Ophthalmology/Retina Service

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Age >= 18 years

2. 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:

   1. Current regular use of insulin for the treatment of diabetes
   2. Current regular use of oral anti-hyperglycemia agents for the treatment of diabetes
   3. Documented diabetes by American Diabetes Association (ADA) and/or World Health Organization (WHO) criteria.
3. Able and willing to provide informed consent.

Meets all of the following ocular criteria in at least the one eye:

1. Best corrected E-ETDRS visual acuity letter score ≥ 79 (approximate Snellen equivalent 20/25 or better) at two consecutive visits within 1 to 28 days.
2. On clinical exam, definite retinal thickening due to DME involving the center of the macula.

3. Diabetic macular edema confirmed on OCT (equivalent to CSF thickness on OCT ≥250 microns on Zeiss Stratus or gender-specific spectral domain OCT equivalent) at two consecutive visits within 1 to 28 days.

   (a) Investigator must verify accuracy of OCT scan by ensuring it is centered and of adequate quality.

4. The investigator is comfortable with the eye being randomized to any of the three treatment groups (observation, laser, or anti-VEGF initially).

   (a) If focal/grid photocoagulation is contraindicated because all leaking microaneurysms are too close to the fovea or the investigator believes the DME that is present will not benefit from focal/grid photocoagulation, the eye should not be enrolled.

5. Media clarity, pupillary dilation, and individual cooperation sufficient for adequate OCT and fundus photographs.

Exclusion Criteria:

1. History of chronic renal failure requiring dialysis or kidney transplant.
2. 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).
3. Initiation of intensive insulin treatment (a pump or multiple daily injections) within 4 months prior to randomization or plans to do so in the next 4 months.

4. 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.

   (a) Note: study participants cannot receive another investigational drug while participating in the study.

5. Known allergy to any component of the study drug.
6. 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.

7. Systemic anti-VEGF or pro-VEGF treatment within 4 months prior to randomization.

   These drugs should not be used during the study.

8. For women of child-bearing potential: pregnant or lactating or intending to become pregnant within the next 24 months.

   (a) 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.

9. Individual is expecting to move out of the area of the clinical center to an area not covered by another clinical center during the 24 months of the study.

Individual has any of the following ocular characteristics:

1. Macular edema is considered to be due to a cause other than DME.

   a) 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 contributing to the macular edema.

2. An ocular condition is present such that, in the opinion of the investigator, any visual acuity loss would not improve from resolution of macular edema (e.g., foveal atrophy, pigment abnormalities, dense subfoveal hard exudates, nonretinal condition).
3. An ocular condition is present (other than DME) 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.).
4. Cataract is present that, in the opinion of the investigator, may alter visual acuity during the course of the study.
5. Any history of prior laser or other surgical, intravitreal, or peribulbar treatment for DME (such as focal/grid macular photocoagulation, intravitreal or peribulbar corticosteroids, or anti-VEGF).
6. History of topical steroid or nonsteroidal anti-inflammatory drugs (NSAID) treatment within 30 days prior to randomization.
7. History of intravitreal or peribulbar corticosteroid within 4 months prior to randomization for an ocular condition other than DME.
8. Any history of or anticipated need for intravitreal anti-VEGF within the next 6 months for an ocular condition other than DME (e.g. choroidal neovascularization, central retinal vein occlusion, PDR).
9. History of PRP within 4 months prior to randomization or anticipated need for PRP in the 6 months following randomization.
10. Any history of vitrectomy.
11. History of major ocular surgery (cataract extraction, scleral buckle, any intraocular surgery, etc.) within prior 4 months or anticipated within the next 6 months following randomization.
12. History of YAG capsulotomy performed within 2 months prior to randomization.
13. Aphakia.
14. Exam evidence of external ocular infection, including conjunctivitis, chalazion, or significant blepharitis.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Prompt Laser + Deferred Aflibercept; Focal/grid laser followed by intravitreal aflibercept if vision worsens	Procedure: Prompt Laser; Focal/grid laser performed at baseline and as needed during follow-up; Other Names: focal/grid photocoagulation; laser treatment; Drug: Deferred aflibercept; Intravitreal injection of 2.0mg aflibercept performed once certain criteria for vision loss are met and then up to every 4 weeks using defined treatment criteria; Other Names: Eylea; intravitreal anti-VEGF
Active Comparator: Observation + Deferred Aflibercept; No treatment to start followed by intravitreal aflibercept if vision worsens (deferred laser may be added to intravitreal aflibercept if certain criteria are met)	Drug: Deferred aflibercept; Intravitreal injection of 2.0mg aflibercept performed once certain criteria for vision loss are met and then up to every 4 weeks using defined treatment criteria; Other Names: Eylea; intravitreal anti-VEGF; Procedure: Deferred laser; Focal/grid laser is initiated while receiving anti-VEGF injections only if certain criteria are met; Other Names: focal/grid photocoagulation; laser treatment
Experimental: Prompt Aflibercept; Intravitreal aflibercept at baseline and every 4 weeks as needed (deferred laser may be added to intravitreal aflibercept if certain criteria are met)	Procedure: Deferred laser; Focal/grid laser is initiated while receiving anti-VEGF injections only if certain criteria are met; Other Names: focal/grid photocoagulation; laser treatment; Drug: Prompt aflibercept; Intravitreal injection of 2.0mg aflibercept performed on the day of randomization and up to every 4 weeks using defined treatment criteria; Other Names: Eylea; intravitreal anti-VEGF

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Eyes With at Least 5-letter Decrease in E-ETDRS Visual Acuity Letter Score From Baseline	Best-corrected visual acuity following protocol-defined refraction. Visual Acuity was measured with the Electronic Early Treatment Diabetic Retinopathy Study (E-ETDRS) visual acuity test on a scale from 100 letters (Snellen equivalent of 20/12) to 0 letters (Snellen equivalent of 20/800).	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Eyes With at Least 5-letter Increase or at Least 5-, 10-, or 15-letter Decrease in E-ETDRS Visual Acuity Letter Score From Baseline	Best-corrected visual acuity following protocol-defined refraction. Visual Acuity was measured with the Electronic Early Treatment Diabetic Retinopathy Study (E-ETDRS) visual acuity test on a scale from 100 letters (Snellen equivalent of 20/12) to 0 letters (Snellen equivalent of 20/800).	1 year
Change in E-ETDRS Visual Acuity Letter Score From Baseline	Best-corrected visual acuity following protocol-defined refraction. Visual Acuity was measured with the Electronic Early Treatment Diabetic Retinopathy Study (E-ETDRS) visual acuity test on a scale from 100 letters (Snellen equivalent of 20/12) to 0 letters (Snellen equivalent of 20/800).	1 year
Change in E-ETDRS Visual Acuity Letter Score From Baseline Over 2 Years (Area Under the Curve)	Best-corrected visual acuity following protocol-defined refraction. Visual Acuity was measured with the Electronic Early Treatment Diabetic Retinopathy Study (E-ETDRS) visual acuity test on a scale from 100 letters (Snellen equivalent of 20/12) to 0 letters (Snellen equivalent of 20/800). The area under the curve (units = letters·years) was divided by 2 years (units = years) to obtain an average change in letter score (units = letters) over the 2-year follow-up.	2 year
Change in OCT Central Subfield Thickness From Baseline		2 years
Number of Eyes With at Least 1 or 2 Logarithmic-step Central Subfield Thickness Improvement and Worsening	Logarithmic transformation of optical coherence tomography central subfield thickness (CST) 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.	1 year
Number of Eyes With no Center-involved Diabetic Macular Edema and at Least 10% Central Subfield Thickness Decrease	Center-involved diabetic macular edema defined as follows by central subfield thickness according to optical coherence tomography machine and sex: Heidelberg Spectralis ≥ 305 µm in women and ≥ 320 µm in men, and Zeiss Cirrus ≥ 290 µm in women and ≥ 305 µm in men.	1 year
Cumulative Number of Intraocular Injections of 2.0-mg Aflibercept Received Per Participant		1 year
Number of Eyes With ≥ 2-step Worsening of Diabetic Retinopathy	Includes eyes with baseline severity level of 75 (high-risk proliferative diabetic retinopathy) or less based on reading center grading of color fundus photographs using the Early Treatment Diabetic Retinopathy Study severity scale.	2 years
For Eyes Randomized to Initial Laser Photocoagulation and Initial Observation Groups, the Percentage Receiving Aflibercept Treatment		2 years
Number of Eyes With at Least 5-, 10-, or 15-letter Decrease in E-ETDRS Visual Acuity Letter Score From Baseline	Best-corrected visual acuity following protocol-defined refraction. Visual Acuity was measured with the Electronic Early Treatment Diabetic Retinopathy Study (E-ETDRS) visual acuity test on a scale from 100 letters (Snellen equivalent of 20/12) to 0 letters (Snellen equivalent of 20/800).	2 years
Change in E-ETDRS Visual Acuity Letter Score From Baseline	Best-corrected visual acuity following protocol-defined refraction. Visual Acuity was measured with the Electronic Early Treatment Diabetic Retinopathy Study (E-ETDRS) visual acuity test on a scale from 100 letters (Snellen equivalent of 20/12) to 0 letters (Snellen equivalent of 20/800).	2 years
Change in OCT Central Subfield Thickness From Baseline	Measured using spectral-domain optical coherence tomography (OCT).	1 year
Number of Eyes With at Least 1 or 2 Logarithmic-step Central Subfield Thickness 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.	2 years
Number of Eyes With no Center-involved Diabetic Macular Edema and at Least 10% Central Subfield Thickness Decrease	Center-involved diabetic macular edema defined as follows by central subfield thickness according to optical coherence tomography machine and sex: Heidelberg Spectralis ≥ 305 µm in women and ≥ 320 µm in men, and Zeiss Cirrus ≥ 290 µm in women and ≥ 305 µm in men.	2 years
Cumulative Number of Focal/Grid Photocoagulation Sessions Performed Per Participant		2 years
Number of Eyes With ≥ 2-step Improvement of Diabetic Retinopathy	Includes eyes with baseline severity level of 35 (mild non-proliferative diabetic retinopathy) or greater based on reading center grading of color fundus photographs using the Early Treatment Diabetic Retinopathy Study severity scale. Excludes eyes with severity level 60 at baseline since improvement is not possible in these eyes.	2 years
Cumulative Number of Intraocular Injections of 2.0-mg Aflibercept Received Per Participant		2 years

Collaborators and Investigators

• Sponsor: Jaeb Center for Health Research
• Collaborators: National Eye Institute (NEI); National Institutes of Health (NIH); Regeneron Pharmaceuticals
• Investigators: Study Chair: Carl Baker, MD, Paducah Retina Center; Principal Investigator: Adam Glassman, MS, Jaeb Center for Health Research

Publications and helpful links

General Publications

• Glassman AR, Baker CW, Beaulieu WT, Bressler NM, Punjabi OS, Stockdale CR, Wykoff CC, Jampol LM, Sun JK; DRCR Retina Network. Assessment of the DRCR Retina Network Approach to Management With Initial Observation for Eyes With Center-Involved Diabetic Macular Edema and Good Visual Acuity: A Secondary Analysis of a Randomized Clinical Trial. JAMA Ophthalmol. 2020 Apr 1;138(4):341-349. doi: 10.1001/jamaophthalmol.2019.6035.
• Baker CW, Glassman AR, Beaulieu WT, Antoszyk AN, Browning DJ, Chalam KV, Grover S, Jampol LM, Jhaveri CD, Melia M, Stockdale CR, Martin DF, Sun JK; DRCR Retina Network. Effect of Initial Management With Aflibercept vs Laser Photocoagulation vs Observation on Vision Loss Among Patients With Diabetic Macular Edema Involving the Center of the Macula and Good Visual Acuity: A Randomized Clinical Trial. JAMA. 2019 May 21;321(19):1880-1894. doi: 10.1001/jama.2019.5790.

Study record dates

Study Major Dates

• Study Start: October 1, 2013
• Primary Completion (Actual): September 11, 2018
• Study Completion (Actual): September 11, 2018

Study Registration Dates

• First Submitted: July 23, 2013
• First Submitted That Met QC Criteria: July 26, 2013
• First Posted (Estimate): July 29, 2013

Study Record Updates

• Last Update Posted (Actual): July 31, 2020
• Last Update Submitted That Met QC Criteria: July 14, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: Diabetic Macular Edema; anti-vascular endothelial growth factor
• Additional Relevant MeSH Terms: Eye Diseases; Retinal Degeneration; Retinal Diseases; Macular Degeneration; Macular Edema; Edema; Physiological Effects of Drugs; Antineoplastic Agents; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Aflibercept
• Other Study ID Numbers: DRCR.net Protocol V; EY14231 (Other Grant/Funding Number: National Eye Institute); EY23207 (Other Grant/Funding Number: National Eye Institute); EY18817 (Other Grant/Funding Number: National Eye Institute)