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
- Proliferative Diabetic Retinopathy
- Vitreous Hemorrhage
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Ranibizumab — DRUGIntravitreal injection of 0.5 mg ranibizumab (Lucentis™) at baseline, 4 and 8 weeks
- Saline — DRUGSaline 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 InjectionSaline injection at baseline, 4 and 8 weeks
- Active Comparator: RanibizumabIntravitreal 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)
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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
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