Phase
Condition
Diabetic Retinopathy
Diabetic Vitreous Hemorrhage
Retina
Treatment
N/AClinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria: Age >= 18 years -Individuals < 18 years old are not being included because proliferativediabetic retinopathy (PDR) is so rare in this age group that the diagnosis of PDR may bequestionable. Diagnosis of diabetes mellitus (type 1 or type 2) Any one of the following will be considered to be sufficient evidence that diabetes ispresent:
- 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 (ADA) and/or World HealthOrganization (WHO) criteria (see Procedures Manual for definitions) Able and willingto provide informed consent. Meets at least all of the following ocular criteria criteria:
- Presence of PDR which the investigator intends to manage with PRP alone but for whichPRP can be deferred for at least 4 weeks in the setting of intravitreal ranibizumab,in the investigator's judgment.
- Best corrected Electronic-Early Treatment Diabetic Retinopathy Study (E-ETDRS) visualacuity letter score > 24 (approximate Snellen equivalent 20/320) on the day ofrandomization.
- Media clarity, pupillary dilation, and study participant cooperation sufficient toadminister PRP and obtain adequate fundus photographs and optical coherence tomography (OCT).
- Investigator must verify accuracy of OCT scan by ensuring it is centered and ofadequate quality
Exclusion
Exclusion Criteria: Significant renal disease, defined as a history of chronic renal failure requiring dialysisor kidney transplant. A condition that, in the opinion of the investigator, would preclude participation in thestudy (e.g., unstable medical status including blood pressure, cardiovascular disease, andglycemic control).
- Individuals in poor glycemic control who, within the last 4 months, initiatedintensive insulin treatment (a pump or multiple daily injections) or plan to do so inthe next 4 months should not be enrolled. Participation in an investigational trial within 30 days of randomization that involvedtreatment with any drug that has not received regulatory approval for the indication beingstudied.
- Study participants cannot receive another investigational drug while participating inthe 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, individualcan become eligible. Myocardial infarction, other acute cardiac event requiring hospitalization, stroke,transient ischemic attack, or treatment for acute congestive heart failure within 4 monthsprior to randomization. Systemic anti-VEGF or pro-VEGF treatment within 4 months prior to randomization.
- These drugs should not be used during the study. For women of child-bearing potential: pregnant or lactating or intending to become pregnantwithin the next 3 years.
- Women who are potential study participants should be questioned about the potentialfor pregnancy. Investigator judgment is used to determine when a pregnancy test isneeded. Individual is expecting to move out of the area of the clinical center to an area notcovered by another Diabetic Retinopathy Clinical Research Network (DRCR.net) certifiedclinical center during the 3 years of the study. Individual has any of the following ocular characteristics:
- History of prior panretinal photocoagulation (prior PRP is defined as ≥ 100 burnsoutside of the posterior pole)
- Tractional retinal detachment involving the macula. -- A tractional retinal detachment is not an exclusion if it is outside of theposterior pole (not threatening the macula) and in the investigator's judgment, is nota contraindication to intravitreal ranibizumab treatment and also does not precludedeferring PRP for at least 4 weeks in the setting of intravitreal ranibizumab
- Exam evidence of neovascularization of the angle (neovascularization of the iris aloneis not an exclusion if it does not preclude deferring PRP for at least 4 weeks in theinvestigator's judgment).
- If macular edema is present, it is considered to be primarily due to a cause otherthan diabetic macular edema. -- An eye should not be considered eligible if:
- macular edema is present that is considered to be related to ocular surgery suchas cataract extraction or
- clinical exam and/or OCT suggest that vitreoretinal interface abnormalitiesdisease (e.g., a taut posterior hyaloid or epiretinal membrane) is the primarycause of any macular edema.
- An ocular condition is present (other than diabetic retinopathy) that, in the opinionof the investigator, might alter visual acuity during the course of the study (e.g.,retinal vein or artery occlusion, uveitis or other ocular inflammatory disease,neovascular glaucoma, etc.). -- A vitreous or preretinal hemorrhage is not an exclusion if it is out of the visualaxis and in the investigator's judgment is not having any affect on visual acuity.
- Substantial cataract that, in the opinion of the investigator, is likely to bedecreasing visual acuity by 3 lines or more (i.e., cataract would be reducing acuityto 20/40 or worse if eye were otherwise normal).
- History of intravitreal anti-VEGF treatment at any time in the past 2 months.
- History of corticosteroid treatment (intravitreal or peribulbar) at any time in thepast 4 months. --If the investigator believes that there may still be a substantial effect 4 monthsafter prior treatment (e.g., dose of intravitreal triamcinolone higher than 4 mg), theeye should not be included.
- History of major ocular surgery (including vitrectomy, cataract extraction, scleralbuckle, any intraocular surgery, etc.) within prior 4 months or anticipated within thenext 6 months following randomization.
- History of (yttrium-aluminum-garnet) YAG capsulotomy performed within 2 months priorto randomization.
- Aphakia.
- Uncontrolled glaucoma (in investigator's judgment).
- Exam evidence of severe external ocular infection, including conjunctivitis,chalazion, or substantial blepharitis
Study Design
Connect with a study center
Retinal Consultants of AZ
Phoenix, Arizona 85014
United StatesSite Not Available
Loma Linda University Health Care, Dept. of Ophthalmology
Loma Linda, California 92354
United StatesSite Not Available
Southern California Desert Retina Consultants, MC
Palm Springs, California 92262
United StatesSite Not Available
California Retina Consultants
Santa Barbara, California 93103
United StatesSite Not Available
Bay Area Retina Associates
Walnut Creek, California 94598
United StatesSite Not Available
New England Retina Associates
Trumbull, Connecticut 06611
United StatesSite Not Available
Retina Consultants of Southwest Florida
Fort Myers, Florida 33912
United StatesSite Not Available
Central Florida Retina Institute
Lakeland, Florida 33805
United StatesSite Not Available
Ocala Eye Retina Consultants
Ocala, Florida 34474
United StatesSite Not Available
Fort Lauderdale Eye Institute
Plantation, Florida 33324
United StatesSite Not Available
Retina Associates of Sarasota
Venice, Florida 34285
United StatesSite Not Available
Southeast Retina Center, P.C.
Augusta, Georgia 30909
United StatesSite Not Available
North Shore University Health System
Glenview, Illinois 60026
United StatesSite Not Available
Raj K. Maturi, M.D., P.C.
Indianapolis, Indiana 46290
United StatesSite Not Available
John-Kenyon American Eye Institute
New Albany, Indiana 47150
United StatesSite Not Available
Wolfe Eye Clinic
West Des Moines, Iowa 50266
United StatesSite Not Available
Retina and Vitreous Associates of Kentucky
Lexington, Kentucky 40509-1802
United StatesSite Not Available
Paducah Retinal Center
Paducah, Kentucky 42001
United StatesSite Not Available
Elman Retina Group, P.A.
Baltimore, Maryland 21237
United StatesSite Not Available
Vitreo-Retinal Associates, PC
Worcester, Massachusetts 01605
United StatesSite Not Available
Retina Vitrous Center
Grand Blanc, Michigan 48439
United StatesSite Not Available
Barnes Retina Institute
Saint Louis, Missouri 63110
United StatesSite Not Available
Barnes Retina Institute
St. Louis, Missouri 63110
United StatesSite Not Available
Eye Surgical Associates
Lincoln, Nebraska 38506
United StatesSite Not Available
The New York Eye and Ear Infirmary/Faculty Eye Practice
New York, New York 10003
United StatesSite Not Available
University of Rochester
Rochester, New York 14642
United StatesSite Not Available
Retina-Vitreous Surgeons of Central New York, PC
Syracuse, New York 13224
United StatesSite Not Available
University of North Carolina
Chapel Hill, North Carolina 27599-7040
United StatesSite Not Available
Charlotte Eye, Ear, Nose and Throat Assoc., PA
Charlotte, North Carolina 28210
United StatesSite Not Available
Retina Associates of Cleveland, Inc.
Beachwood, Ohio 44122
United StatesSite Not Available
Casey Eye Institute
Portland, Oregon 97239
United StatesSite Not Available
Retina Northwest, PC
Portland, Oregon 97210
United StatesSite Not Available
Penn State College of Medicine
Hershey, Pennsylvania 17033
United StatesSite Not Available
Family Eye Group
Lancaster, Pennsylvania 17601-2644
United StatesSite Not Available
Retina Vitrous Consultants
Pittsburg, Pennsylvania 15213
United StatesSite Not Available
Retina Vitrous Consultants
Pittsburgh, Pennsylvania 15213
United StatesSite Not Available
Carolina Retina Center
Columbia, South Carolina 29223
United StatesSite Not Available
Southeastern Retina Associates, PC
Kingsport, Tennessee 37660
United StatesSite Not Available
Southeastern Retina Associates, P.C.
Knoxville, Tennessee 37909
United StatesSite Not Available
Austin Retina Associates
Austin, Texas 78705
United StatesSite Not Available
Retina Research Center
Austin, Texas 78705
United StatesSite Not Available
Texas Retina Associates
Dallas, Texas 75231
United StatesSite Not Available
Baylor Eye Physicians and Surgeons
Houston, Texas 77030
United StatesSite Not Available
Retina and Vitreous of Texas
Houston, Texas 77025
United StatesSite Not Available
Texas Retina Associates
Lubbock, Texas 79424
United StatesSite Not Available
Valley Retina Institute
McAllen, Texas 78503
United StatesSite Not Available
Retinal Consultants of San Antonio
San Antonio, Texas 78240
United StatesSite Not Available
University of Washington Medical Center
Seattle, Washington 98195
United StatesSite Not Available
Spokane Eye Clinic
Spokane, Washington 99204
United StatesSite Not Available
Medical College of Wiconsin
Milwaukee, Wisconsin 53226
United StatesSite Not Available
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