Intravitreal Ranibizumab for Vitreous Hemorrhage Due to Proliferative Diabetic Retinopathy (N)

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Jaeb Center for Health Research
Study ID
NCT00996437
Phase
PHASE2/PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ranibizumab — DRUG
    Intravitreal injection of 0.5 mg ranibizumab (Lucentis™) at baseline, 4 and 8 weeks
  • Saline — DRUG
    Saline injection of 0.5mg at baseline, 4 and 8 weeks

Study Details

This study is being conducted to determine if intravitreal injections of ranibizumab decrease the proportion of eyes in which vitrectomy is performed compared with saline injections in eyes presenting with vitreous hemorrhage from proliferative diabetic retinopathy.

Key Dates

First listed
Oct 16, 2009
Start date
Jun 30, 2010
Status verified
Aug 2016
Primary completion
Feb 29, 2012
Completion
Jan 31, 2013

Study Design

Enrollment
261 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Placebo Comparator: Saline Injection
    Saline injection at baseline, 4 and 8 weeks
  • Active Comparator: Ranibizumab
    Intravitreal injection of 0.5 mg ranibizumab (Lucentis™) at baseline, 4 and 8 weeks

Primary Outcome Measure

Treatment or "Failure" Defined as Vitrectomy [ Time Frame: within 112 days of randomization ]

Locations (67)

FacilityCityStateZIPSite coordinators
Retinal Consultants of AZPhoenixArizona85014-
University of California, IrvineIrvineCalifornia92697-
Loma Linda University Health Care, Dept. of OphthalmologyLoma LindaCalifornia92354-
Southern California Desert Retina Consultants, MCPalm SpringsCalifornia92262-
Bay Area Retina AssociatesWalnut CreekCalifornia94598-
Retinal Consultants of Southern California Medical Group, Inc.Westlake VillageCalifornia91361-
Denver Health Medical CenterDenverColorado80204-
New England Retina Associates, PCTrumbullConnecticut06611-
The George Washington University, Department of OphthalmologyWashington D.C.District of Columbia20037-
Retina Consultants of Southwest FloridaFort MyersFlorida33912-
University of Florida College of Med., Department of OphthalmologyJacksonvilleFlorida32209-
Florida Retina ConsultantsLakelandFlorida33805-
Magruder Eye InstituteOrlandoFlorida32803-
Sarasota Retina InstituteSarasotaFlorida34239-
Retina Associates of SarasotaVeniceFlorida34285-
Emory Eye CenterAtlantaGeorgia30322-
Georgia Retina, P.C.AtlantaGeorgia30342-
Southeast Retina Center, P.C.AugustaGeorgia30909-
Retina Associates of Hawaii, Inc.HonoluluHawaii96813-
University of Illinois at Chicago Medical CenterChicagoIllinois60612-
Raj K. Maturi, M.D., P.C.IndianapolisIndiana46290-
American Eye InstituteNew AlbanyIndiana47150-
Medical Associates Clinic, P.C.DubuqueIowa52002-
Wolfe Eye ClinicWest Des MoinesIowa50266-
Sabates Eye Centers Research DivisionLeawoodKansas66211-
Retina and Vitreous Associates of KentuckyLexingtonKentucky40509-1802-
Paducah Retinal CenterPaducahKentucky42001-
Elman Retina Group, P.A.BaltimoreMaryland21237-
Wilmer Eye Institute at Johns HopkinsBaltimoreMaryland21287-9177-
Wilmer Eye Institute at Johns HopkinsBaltimoreMaryland21287-9277-
Retina Consultants of Delmarva, P.A.SalisburyMaryland21804-
Joslin Diabetes CenterBostonMassachusetts02215-
Henry Ford Health System, Dept of Ophthalmology and Eye Care ServicesDetroitMichigan48202-
Vitreo-Retinal AssociatesGrand RapidsMichigan49525-
Retina Center, PAMinneapolisMinnesota55404-
Barnes Retina InstituteSt LouisMissouri63110-
Delaware Valley Retina AssociatesLawrencevilleNew Jersey08648-
Mount Sinai School of Medicine, Dept. of OphthalmologyNew YorkNew York10029-
The New York Eye and Ear Infirmary/Faculty Eye PracticeNew YorkNew York10003-
Retina Consultants of Western New YorkOrchard ParkNew York14127-
Eye Care for the AdirondacksPlattsburghNew York12901-
Retina-Vitreous Surgeons of Central New York, PCSyracuseNew York13224-
University of North Carolina, Dept of OphthalmologyChapel HillNorth Carolina27599-7040-
Charlotte Eye Ear Nose and Throat Assoc, PACharlotteNorth Carolina28210-
Piedmont Retina Specialists, PAGreensboroNorth Carolina27401-
Mid-America Retina Consultants, P.A.Kansas CityNorth Carolina64111-
Wake Forest University Eye CenterWinston-SalemNorth Carolina27157-
Retina Associates of Cleveland, Inc.BeachwoodOhio44122-
Case Western Reserve UniversityClevelandOhio44106-
OSU Eye Physicians and Surgeons, LLC.ColumbusOhio43212-
Retina Northwest, PCPortlandOregon97210-
Family Eye GroupLancasterPennsylvania17601-2644-
University of Pennsylvania Scheie Eye InstitutePhiladelphiaPennsylvania19104-
Carolina Retina CenterColumbiaSouth Carolina29223-
Southeastern Retina Associates, PCKingsportTennessee37660-
Southeastern Retina Associates, P.C.KnoxvilleTennessee37909-
West Texas Retina Consultants P.A.AbileneTexas79605-
Retina Research CenterAustinTexas78705-
Baylor Eye Physicians and SurgeonsHoustonTexas77030-
Retina and Vitreous of TexasHoustonTexas77025-
Texas Retina AssociatesLubbockTexas79424-
Valley Retina InstituteMcAllenTexas78503-
Medical Center Ophthalmology AssociatesSan AntonioTexas78240-
Retinal Consultants of San AntonioSan AntonioTexas78240-
Virginia Retina CenterLeesburgVirginia20176-
University of Washington Medical CenterSeattleWashington98195-
Medical College of WiconsinMilwaukeeWisconsin53226-

Find similar trials in Phoenix, AZ

By condition
Diabetic retinopathy
By specialty
OphthalmologyRetina
By research site
Retinal Consultants of AZ· Phoenix, AZUniversity of California, Irvine· Irvine, CALoma Linda University Health Care, Dept. of Ophthalmology· Loma Linda, CASouthern California Desert Retina Consultants, MC· Palm Springs, CABay Area Retina Associates· Walnut Creek, CARetinal Consultants of Southern California Medical Group, Inc.· Westlake Village, CA