Laser-Ranibizumab-Triamcinolone for Proliferative Diabetic Retinopathy

Part of paid clinical trials in Artesia, California.

Sponsor
Jaeb Center for Health Research
Study ID
NCT00445003
Phase
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 at baseline and 4 weeks
  • Triamcinolone Acetonide — DRUG
    Intravitreal injection of 4 mg triamcinolone acetonide at baseline and sham injection at 4 weeks
  • Sham injection — BEHAVIORAL
    Sham injection at baseline and 4 weeks
  • Focal/grid laser — PROCEDURE
    Focal/grid laser for diabetic macular edema was performed 3 days to 10 days after the injection for all treatment groups.

Study Details

The purpose of the study is to find out if treatment with an intravitreal injection of triamcinolone or an intravitreal injection of ranibizumab can prevent loss of vision caused by panretinal photocoagulation treatment. At the present time, it is not known whether intravitreal steroid or anti-vascular endothelial growth factor (anti-VEGF) injections are beneficial in preventing vision loss after panretinal photocoagulation (PRP) treatment. It is possible that one or both of the types of injections will prevent vision loss after PRP treatment. However, it is not known whether the benefits of the injections will outweigh the risks. It is possible that because of side effects, the injections may not be as good as laser alone in treating the diabetic retinopathy.

Key Dates

First listed
Mar 8, 2007
Start date
Mar 31, 2007
Status verified
Aug 2016
Primary completion
Oct 31, 2009
Completion
Jul 31, 2010

Study Design

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

Arms

  • Experimental: Sham injection plus laser
    Sham injection at baseline and 4 weeks. Focal/grid laser for diabetic macular edema was performed 3 days to 10 days after the injection for all treatment groups.
  • Experimental: 0.5mg Ranibizumab plus laser
    Intravitreal injections of 0.5mg Ranibizumab at baseline and at 4 weeks. Focal/grid laser for diabetic macular edema was performed 3 days to 10 days after the injection for all treatment groups.
  • Active Comparator: 4-mg Triamcinolone Acetonide plus Laser
    4-mg Triamcinolone Acetonide at baseline and sham injection at 4 weeks. Focal/grid laser for diabetic macular edema was performed 3 days to 10 days after the injection for all treatment groups.

Primary Outcome Measure

Change in Electronic Early Treatment Diabetic Retinopathy Study Visual Acuity Letter Score From Baseline to 14 Weeks [ Time Frame: baseline to 14 weeks ]

Locations (56)

FacilityCityStateZIPSite coordinators
Sall Research Medical CenterArtesiaCalifornia90701-
Retina-Vitreous Associates Medical GroupBeverly HillsCalifornia90211-
University of California, IrvineIrvineCalifornia92697-
Loma Linda University Health Care, Dept. of OphthalmologyLoma LindaCalifornia92354-
Southern California Desert Retina Consultants, MCPalm SpringsCalifornia92262-
California Retina ConsultantsSanta BarbaraCalifornia93103-
Bay Area Retina AssociatesWalnut CreekCalifornia94598-
Eldorado Retina Associates, P.C.LouisvilleColorado80027-
Retina Vitreous ConsultantsFort LauderdaleFlorida33334-
Retina Consultants of Southwest FloridaFort MyersFlorida33912-
Central Florida Retina InstituteLakelandFlorida33805-
Southeast Retina Center, P.C.AugustaGeorgia30909-
University of Illinois at Chicago Medical CenterChicagoIllinois60612-
Illinois Retina AssociatesJolietIllinois60435-
Raj K. Maturi, M.D., P.C.IndianapolisIndiana46280-
John-Kenyon American Eye InstituteNew AlbanyIndiana47150-
Medical Associates Clinic, P.C.DubuqueIowa52002-
Paducah Retinal CenterPaducahKentucky42001-
Maine Vitreoretinal ConsultantsBangorMaine04401-
Elman Retina Group, P.A.BaltimoreMaryland21237-
Wilmer Ophthalmological Institute at Johns HopkinsBaltimoreMaryland21287-9277-
Retina Consultants of Delmarva, P.A.SalisburyMaryland21801-
Joslin Diabetes CenterBostonMassachusetts02215-
Ophthalmic Consultants of BostonBostonMassachusetts02114-
Retina Center, PAMinneapolisMinnesota55404-
University of MinnesotaMinneapolisMinnesota55455-
Eyesight Ophthalmic Services, PAPortsmouthNew Hampshire03801-
The New York Eye and Ear Infirmary/Faculty Eye PracticeNew YorkNew York10003-
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-
Horizon Eye Care, PACharlotteNorth Carolina28211-
Wake Forest University Eye CenterWinston-SalemNorth Carolina27157-
Case Western Reserve UniversityClevelandOhio44106-
OSU Eye Physicians and Surgeons, LLC.DublinOhio43017-
Casey Eye InstitutePortlandOregon97239-
Retina Northwest, PCPortlandOregon97210-
Penn State College of MedicineHersheyPennsylvania17033-
University of Pennsylvania Scheie Eye InstitutePhiladelphiaPennsylvania19104-
Retina ConsultantsProvidenceRhode Island02903-
Carolina Retina CenterColumbiaSouth Carolina29223-
Palmetto Retina CenterColumbiaSouth Carolina29169-
Southeastern Retina Associates, PCKingsportTennessee37660-
Southeastern Retina Associates, P.C.KnoxvilleTennessee37909-
West Texas Retina Consultants P.A.AbileneTexas79605-
Texas Retina AssociatesArlingtonTexas76012-
Retina Research CenterAustinTexas78705-
Texas Retina AssociatesDallasTexas75231-
Retina and Vitreous of TexasHoustonTexas77025-
Vitreoretinal ConsultantsHoustonTexas77030-
Texas Retina AssociatesLubbockTexas79424-
Valley Retina InstituteMcAllenTexas78503-
Retinal Consultants of San AntonioSan AntonioTexas78240-
Virginia Retina CenterLeesburgVirginia20176-
University of Washington Medical CenterSeattleWashington98195-
University of Wisconsin-Madison, Dept of Ophthalmology/Retina ServiceMadisonWisconsin53705-

Find similar trials in Artesia, CA

By condition
Diabetic retinopathy
By specialty
OphthalmologyRetina
By research site
Sall Research Medical Center· Artesia, CARetina-Vitreous Associates Medical Group· Beverly Hills, CAUniversity of California, Irvine· Irvine, CALoma Linda University Health Care, Dept. of Ophthalmology· Loma Linda, CASouthern California Desert Retina Consultants, MC· Palm Springs, CACalifornia Retina Consultants· Santa Barbara, CA

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