Prompt Panretinal Photocoagulation Versus Ranibizumab+Deferred Panretinal Photocoagulation for Proliferative Diabetic Retinopathy

Last updated: October 27, 2021
Sponsor: Jaeb Center for Health Research
Overall Status: Completed

Phase

3

Condition

Diabetic Retinopathy

Diabetic Vitreous Hemorrhage

Retina

Treatment

N/A

Clinical Study ID

NCT01489189
DRCR.net Protocol S
  • Ages > 18
  • All Genders

Study Summary

The primary objective of the protocol is to determine if visual acuity outcomes at 2 years in eyes with proliferative diabetic retinopathy (PDR) that receive anti-vascular endothelial growth factor (anti-VEGF) therapy with deferred panretinal photocoagulation (PRP) are non-inferior to those in eyes that receive standard prompt PRP therapy.

Secondary objectives include:

  • Comparing other visual function outcomes (including Humphrey visual field testing and study participant self-reports of visual function) in eyes receiving anti-VEGF with deferred PRP with those in eyes receiving prompt PRP.

  • Determining percent of eyes not requiring PRP when anti-VEGF is given in the absence of prompt PRP.

  • Comparing safety outcomes between treatment groups.

  • Comparing associated treatment and follow-up exam costs between treatment groups.

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

Total Participants: 305
Study Start date:
March 01, 2012
Estimated Completion Date:
February 05, 2018

Connect with a study center

  • Retinal Consultants of AZ

    Phoenix, Arizona 85014
    United States

    Site Not Available

  • Loma Linda University Health Care, Dept. of Ophthalmology

    Loma Linda, California 92354
    United States

    Site Not Available

  • Southern California Desert Retina Consultants, MC

    Palm Springs, California 92262
    United States

    Site Not Available

  • California Retina Consultants

    Santa Barbara, California 93103
    United States

    Site Not Available

  • Bay Area Retina Associates

    Walnut Creek, California 94598
    United States

    Site Not Available

  • New England Retina Associates

    Trumbull, Connecticut 06611
    United States

    Site Not Available

  • Retina Consultants of Southwest Florida

    Fort Myers, Florida 33912
    United States

    Site Not Available

  • Central Florida Retina Institute

    Lakeland, Florida 33805
    United States

    Site Not Available

  • Ocala Eye Retina Consultants

    Ocala, Florida 34474
    United States

    Site Not Available

  • Fort Lauderdale Eye Institute

    Plantation, Florida 33324
    United States

    Site Not Available

  • Retina Associates of Sarasota

    Venice, Florida 34285
    United States

    Site Not Available

  • Southeast Retina Center, P.C.

    Augusta, Georgia 30909
    United States

    Site Not Available

  • North Shore University Health System

    Glenview, Illinois 60026
    United States

    Site Not Available

  • Raj K. Maturi, M.D., P.C.

    Indianapolis, Indiana 46290
    United States

    Site Not Available

  • John-Kenyon American Eye Institute

    New Albany, Indiana 47150
    United States

    Site Not Available

  • Wolfe Eye Clinic

    West Des Moines, Iowa 50266
    United States

    Site Not Available

  • Retina and Vitreous Associates of Kentucky

    Lexington, Kentucky 40509-1802
    United States

    Site Not Available

  • Paducah Retinal Center

    Paducah, Kentucky 42001
    United States

    Site Not Available

  • Elman Retina Group, P.A.

    Baltimore, Maryland 21237
    United States

    Site Not Available

  • Vitreo-Retinal Associates, PC

    Worcester, Massachusetts 01605
    United States

    Site Not Available

  • Retina Vitrous Center

    Grand Blanc, Michigan 48439
    United States

    Site Not Available

  • Barnes Retina Institute

    Saint Louis, Missouri 63110
    United States

    Site Not Available

  • Barnes Retina Institute

    St. Louis, Missouri 63110
    United States

    Site Not Available

  • Eye Surgical Associates

    Lincoln, Nebraska 38506
    United States

    Site Not Available

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

    New York, New York 10003
    United States

    Site Not Available

  • University of Rochester

    Rochester, New York 14642
    United States

    Site Not Available

  • Retina-Vitreous Surgeons of Central New York, PC

    Syracuse, New York 13224
    United States

    Site Not Available

  • University of North Carolina

    Chapel Hill, North Carolina 27599-7040
    United States

    Site Not Available

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

    Charlotte, North Carolina 28210
    United States

    Site Not Available

  • Retina Associates of Cleveland, Inc.

    Beachwood, Ohio 44122
    United States

    Site Not Available

  • Casey Eye Institute

    Portland, Oregon 97239
    United States

    Site Not Available

  • Retina Northwest, PC

    Portland, Oregon 97210
    United States

    Site Not Available

  • Penn State College of Medicine

    Hershey, Pennsylvania 17033
    United States

    Site Not Available

  • Family Eye Group

    Lancaster, Pennsylvania 17601-2644
    United States

    Site Not Available

  • Retina Vitrous Consultants

    Pittsburg, Pennsylvania 15213
    United States

    Site Not Available

  • Retina Vitrous Consultants

    Pittsburgh, Pennsylvania 15213
    United States

    Site Not Available

  • Carolina Retina Center

    Columbia, South Carolina 29223
    United States

    Site Not Available

  • Southeastern Retina Associates, PC

    Kingsport, Tennessee 37660
    United States

    Site Not Available

  • Southeastern Retina Associates, P.C.

    Knoxville, Tennessee 37909
    United States

    Site Not Available

  • Austin Retina Associates

    Austin, Texas 78705
    United States

    Site Not Available

  • Retina Research Center

    Austin, Texas 78705
    United States

    Site Not Available

  • Texas Retina Associates

    Dallas, Texas 75231
    United States

    Site Not Available

  • Baylor Eye Physicians and Surgeons

    Houston, Texas 77030
    United States

    Site Not Available

  • Retina and Vitreous of Texas

    Houston, Texas 77025
    United States

    Site Not Available

  • Texas Retina Associates

    Lubbock, Texas 79424
    United States

    Site Not Available

  • Valley Retina Institute

    McAllen, Texas 78503
    United States

    Site Not Available

  • Retinal Consultants of San Antonio

    San Antonio, Texas 78240
    United States

    Site Not Available

  • University of Washington Medical Center

    Seattle, Washington 98195
    United States

    Site Not Available

  • Spokane Eye Clinic

    Spokane, Washington 99204
    United States

    Site Not Available

  • Medical College of Wiconsin

    Milwaukee, Wisconsin 53226
    United States

    Site Not Available

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