Intravitreal Ranibizumab for Vitreous Hemorrhage Due to Proliferative Diabetic Retinopathy (N)
- Conditions
- Vitreous HemorrhageProliferative Diabetic Retinopathy
- Interventions
- Drug: Saline
- Registration Number
- NCT00996437
- Lead Sponsor
- Jaeb Center for Health Research
- Brief Summary
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.
- Detailed Description
In mild to moderate cases of vitreous hemorrhage, panretinal photocoagulation (PRP) is performed when possible to achieve regression of new vessels or at least stabilization of the neovascularization with no further growth in order to decrease the probability of subsequent vitreous hemorrhage while spontaneous absorption of the hemorrhage occurs. In cases in which the hemorrhage is too dense to apply PRP, vitrectomy is considered to remove the hemorrhage and provide a clear media for application of PRP (often as endolaser photocoagulation) as well as eliminate extensive neovascularization and relieve traction retinal detachments. Pars plana vitrectomy was introduced in the 1970s as a surgical intervention in diabetes for non-clearing vitreous hemorrhage, traction retinal detachment or very severe proliferative diabetic retinopathy (PDR). The goal of vitrectomy in such eyes is to remove the hemorrhage and provide a clear media for application of PRP (often as endolaser photocoagulation) as well as eliminate extensive neovascularization and relieve traction retinal detachments. Many advances in instrumentation and technique have resulted in a dramatic reduction in complications over the last few decades, but surgical complications remain including the following: neovascular glaucoma, retinal detachment, fibrinoid syndrome, endophthalmitis and hypotony with subsequent phthisis bulbi. Recovery for the subject can take up to 6 weeks.
Increased vascular endothelial growth factor (VEGF) levels have been demonstrated in the retina and vitreous of human eyes with diabetic retinopathy, especially PDR. VEGF has been demonstrated to increase vessel permeability by increasing the phosphorylation of tight junction proteins, and has been shown to increase retinal vascular permeability in in vivo models. Anti-VEGF therapy, therefore, may represent a useful therapeutic modality which targets the underlying pathogenesis of PDR while vitreous hemorrhage clears to facilitate the placement of PRP, potentially avoiding vitrectomy.
This study is designed to determine if intravitreal injections of ranibizumab will facilitate clearing of vitreous hemorrhage and avoidance of vitrectomy and its potential complications. Compared with a surgical intervention, use of an intravitreal agent associated with fewer vitrectomies would be preferable because of the reduced costs, reduced time to treatment, reduced intervention time, relatively low risk of side effects, and reduced recovery time. An intravitreal agent also would be a useful alternative for patients who are unwilling to undergo surgery. Furthermore, the study will determine the safety of this medication in the setting of PDR.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 261
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Saline Injection Saline Saline injection at baseline, 4 and 8 weeks Ranibizumab Ranibizumab Intravitreal injection of 0.5 mg ranibizumab (Lucentis™) at baseline, 4 and 8 weeks
- Primary Outcome Measures
Name Time Method Treatment or "Failure" Defined as Vitrectomy within 112 days of randomization The cumulative probabilities of vitrectomy by 16 weks (112 days) in each group were computed using the life-table method. The treatment group comparison was made using the log-rank test. Data were censored at the time point of the participant's last completed visit.
Safety (Injected-related, Ocular Drug-related and Systemic Drug-related) Baseline to 16 weeks
- Secondary Outcome Measures
Name Time Method Severe Visual Acuity Loss (Defined as <20/200) 4,8 and 12 weeks Very Severe Visual Acuity Loss (Defined as <20/800) 4,8 and 12 weeks Extent of Vitreous Hemorrhage Measured by Optical Coherence Tomography Signal Strength 4, 8 and 12 weeks Optical coherence tomography signal strength was evaluated as a potential indicator of vitreous hemorrhage density in an exploratory analysis. This analysis included only eyes with Optical Coherence Tomography (OCT) signal strength equals to 0 at baseline.
Visual Acuity Adjusted for the Baseline Acuity Regardless of Vitrectomy Status 4, 8 and 12 weeks Visual acuity was analyzed using a longitudinal mixed regression model adjusting for baseline visual acuity.Unit of measure is based on the E-ETDRS visual acuity letter score scale, 0-97, where 0 = worst and 97 = best.
Visual Acuity Better Than 20/40 and no Vitrectomy Prior to the Visit 4, 8 and 12 weeks Ability to Complete Panretinal Photocoagulation (PRP) in the Absence of Vitrectomy within 112 days of randomization The proportion of eyes with "complete" panretinal photocoagulation by 16 weeks in abscence of vitrectomy was computed using the life-table method and treatment groups were compared using the log-rank test.
Trial Locations
- Locations (66)
Sarasota Retina Institute
🇺🇸Sarasota, Florida, United States
Retina Consultants of Southwest Florida
🇺🇸Fort Myers, Florida, United States
Carolina Retina Center
🇺🇸Columbia, South Carolina, United States
Southeastern Retina Associates, PC
🇺🇸Kingsport, Tennessee, United States
Georgia Retina, P.C.
🇺🇸Atlanta, Georgia, United States
Elman Retina Group, P.A.
🇺🇸Baltimore, Maryland, United States
Case Western Reserve University
🇺🇸Cleveland, Ohio, United States
University of Washington Medical Center
🇺🇸Seattle, Washington, United States
Sabates Eye Centers Research Division
🇺🇸Leawood, Kansas, United States
Southern California Desert Retina Consultants, MC
🇺🇸Palm Springs, California, United States
Southeast Retina Center, P.C.
🇺🇸Augusta, Georgia, United States
University of Illinois at Chicago Medical Center
🇺🇸Chicago, Illinois, United States
Denver Health Medical Center
🇺🇸Denver, Colorado, United States
Raj K. Maturi, M.D., P.C.
🇺🇸Indianapolis, Indiana, United States
Henry Ford Health System, Dept of Ophthalmology and Eye Care Services
🇺🇸Detroit, Michigan, United States
Retina Center, PA
🇺🇸Minneapolis, Minnesota, United States
Retina Northwest, PC
🇺🇸Portland, Oregon, United States
Retina and Vitreous of Texas
🇺🇸Houston, Texas, United States
Baylor Eye Physicians and Surgeons
🇺🇸Houston, Texas, United States
Medical Center Ophthalmology Associates
🇺🇸San Antonio, Texas, United States
Retinal Consultants of San Antonio
🇺🇸San Antonio, Texas, United States
Retinal Consultants of AZ
🇺🇸Phoenix, Arizona, United States
Medical College of Wiconsin
🇺🇸Milwaukee, Wisconsin, United States
Retina-Vitreous Surgeons of Central New York, PC
🇺🇸Syracuse, New York, United States
Retinal Consultants of Southern California Medical Group, Inc.
🇺🇸Westlake Village, California, United States
Bay Area Retina Associates
🇺🇸Walnut Creek, California, United States
The George Washington University, Department of Ophthalmology
🇺🇸Washington, District of Columbia, United States
University of Florida College of Med., Department of Ophthalmology
🇺🇸Jacksonville, Florida, United States
Florida Retina Consultants
🇺🇸Lakeland, Florida, United States
New England Retina Associates, PC
🇺🇸Trumbull, Connecticut, United States
Emory Eye Center
🇺🇸Atlanta, Georgia, United States
Retina Associates of Sarasota
🇺🇸Venice, Florida, United States
American Eye Institute
🇺🇸New Albany, Indiana, United States
Wilmer Eye Institute at Johns Hopkins
🇺🇸Baltimore, Maryland, United States
Retina Consultants of Delmarva, P.A.
🇺🇸Salisbury, Maryland, United States
Vitreo-Retinal Associates
🇺🇸Grand Rapids, Michigan, United States
Barnes Retina Institute
🇺🇸St. Louis, Missouri, United States
Retina Consultants of Western New York
🇺🇸Orchard Park, New York, United States
The New York Eye and Ear Infirmary/Faculty Eye Practice
🇺🇸New York, New York, United States
Mount Sinai School of Medicine, Dept. of Ophthalmology
🇺🇸New York, New York, United States
Eye Care for the Adirondacks
🇺🇸Plattsburgh, New York, United States
Charlotte Eye Ear Nose and Throat Assoc, PA
🇺🇸Charlotte, North Carolina, United States
Piedmont Retina Specialists, PA
🇺🇸Greensboro, North Carolina, United States
Mid-America Retina Consultants, P.A.
🇺🇸Kansas City, North Carolina, United States
Retina Associates of Cleveland, Inc.
🇺🇸Beachwood, Ohio, United States
Family Eye Group
🇺🇸Lancaster, Pennsylvania, United States
Southeastern Retina Associates, P.C.
🇺🇸Knoxville, Tennessee, United States
West Texas Retina Consultants P.A.
🇺🇸Abilene, Texas, United States
Texas Retina Associates
🇺🇸Lubbock, Texas, United States
Valley Retina Institute
🇺🇸McAllen, Texas, United States
Virginia Retina Center
🇺🇸Leesburg, Virginia, United States
Loma Linda University Health Care, Dept. of Ophthalmology
🇺🇸Loma Linda, California, United States
Wolfe Eye Clinic
🇺🇸West Des Moines, Iowa, United States
Paducah Retinal Center
🇺🇸Paducah, Kentucky, United States
University of California, Irvine
🇺🇸Irvine, California, United States
Medical Associates Clinic, P.C.
🇺🇸Dubuque, Iowa, United States
Retina and Vitreous Associates of Kentucky
🇺🇸Lexington, Kentucky, United States
Delaware Valley Retina Associates
🇺🇸Lawrenceville, New Jersey, United States
OSU Eye Physicians and Surgeons, LLC.
🇺🇸Columbus, Ohio, United States
University of Pennsylvania Scheie Eye Institute
🇺🇸Philadelphia, Pennsylvania, United States
Joslin Diabetes Center
🇺🇸Boston, Massachusetts, United States
Retina Associates of Hawaii, Inc.
🇺🇸Honolulu, Hawaii, United States
Magruder Eye Institute
🇺🇸Orlando, Florida, United States
University of North Carolina, Dept of Ophthalmology
🇺🇸Chapel Hill, North Carolina, United States
Wake Forest University Eye Center
🇺🇸Winston-Salem, North Carolina, United States
Retina Research Center
🇺🇸Austin, Texas, United States