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Trial record 4 of 17 for:    jaeb | diabetic macular edema

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01909791
Recruitment Status : Completed
First Posted : July 29, 2013
Last Update Posted : March 7, 2019
Sponsor:
Collaborators:
Regeneron Pharmaceuticals
National Eye Institute (NEI)
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Jaeb Center for Health Research

Brief Summary:

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

Condition or disease Intervention/treatment Phase
Diabetic Macular Edema Procedure: Prompt Laser Drug: Prompt aflibercept Procedure: Deferred laser Drug: Deferred aflibercept Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 702 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Treatment for Central-Involved Diabetic Macular Edema in Eyes With Very Good Visual Acuity
Study Start Date : October 2013
Actual Primary Completion Date : September 11, 2018
Actual Study Completion Date : September 11, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema

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:
  • intravitreal anti-VEGF
  • Eylea

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)
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: 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:
  • intravitreal anti-VEGF
  • Eylea

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)
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:
  • intravitreal anti-VEGF
  • Eylea

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




Primary Outcome Measures :
  1. Percent of eyes that have lost at least 5 letters of visual acuity at 2 years compared with baseline mean visual acuity [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. Percent of eyes with at least 5, 10 and 15 letter losses in visual acuity from baseline mean visual acuity [ Time Frame: 1 & 2 years ]
  2. Percent of eyes with at least 5 letter gain in visual acuity from baseline mean visual acuity [ Time Frame: 1 & 2 years ]
  3. Mean change in visual acuity, adjusted for baseline mean visual acuity [ Time Frame: 1 & 2 years ]
  4. Visual acuity area under the curve between baseline and annual visits [ Time Frame: 1 & 2 years ]
  5. Mean change in OCT CSF thickness, adjusted for baseline mean thickness [ Time Frame: 1 & 2 years ]
  6. Percent of eyes with at least a 1 and 2 log step increase or decrease on OCT CSF thickness [ Time Frame: 1 & 2 years ]
  7. Percent of eyes with OCT CSF thickness of <250 µm on Stratus OCT (or spectral domain equivalent) and at least a 10% OCT CSF thickness decrease [ Time Frame: 1 & 2 years ]
  8. Number of injections and/or focal/grid photocoagulation sessions performed [ Time Frame: 1 & 2 years ]
  9. Number of scheduled and unscheduled visits [ Time Frame: 1 & 2 years ]
  10. Percent of eyes with worsening diabetic retinopathy [ Time Frame: 1 & 2 years ]
  11. Of eyes with non-proliferative diabetic retinopathy or proliferative diabetic retinopathy (PDR) at randomization, percent with improvement in diabetic retinopathy [ Time Frame: 1 & 2 years ]
  12. Of eyes with PDR at randomization, proportion of eyes avoiding vitreous hemorrhage or panretinal photocoagulation (PRP) or vitrectomy for PDR [ Time Frame: 1 & 2 years ]
  13. Mean change in low-contrast visual acuity on Electronic Visual Acuity Tester [ Time Frame: 1 & 2 years ]
  14. Total cost of follow-up and treatment [ Time Frame: 1 & 2 years ]
  15. For eyes randomized to deferred anti-VEGF, the percentage of eyes needing anti-VEGF treatment. [ Time Frame: 1 & 2 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01909791


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Jaeb Center for Health Research
ClinicalTrials.gov Identifier: NCT01909791     History of Changes
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 )
First Posted: July 29, 2013    Key Record Dates
Last Update Posted: March 7, 2019
Last Verified: March 2019

Keywords provided by Jaeb Center for Health Research:
Diabetic Macular Edema
anti-vascular endothelial growth factor

Additional relevant MeSH terms:
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Macular Edema
Edema
Macular Degeneration
Signs and Symptoms
Retinal Degeneration
Retinal Diseases
Eye Diseases
Bevacizumab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors