Ranibizumab (Lucentis) for Polypoidal Choroidal Vasculopathy
Part of paid clinical trials in Augusta, Georgia.
- Sponsor
- Southeast Retina Center, Georgia
- Study ID
- NCT00837330
- Phase
- PHASE1/PHASE2
- Status
- Completed
Conditions
- Polypoidal Choroidal Vasculopathy
Eligibility Criteria
- Sex
- ALL
- Age
- 35 Years - N/A
- Healthy Volunteers
- Accepted
Interventions
- ranibizumab 0.5 or 0.3 mg/0.05 cc — DRUGranibizumab 0.5 or 0.3 mg/0.05 cc administered intraocularly on a monthly basis for 3 months, followed by monthly examination with the option of further ranibizumab treatment or other therapies at the discretion of the treating physician
Study Details
This Phase I/II safety study is designed to investigate the safety and efficacy of ranibizumab (Lucentis) in the treatment of polypoidal choroidal vasculopathy (PCV), a potentially blinding eye disease that involves the growth of tiny, abnormal blood vessels under the retina. These abnormal blood vessels can bleed or leak fluid, causing disruption of normal retinal function and vision loss. Ranibizumab is a drug that is FDA-approved for the treatment of wet age-related macular degeneration (AMD) and is injected directly into the eye. Given the efficacy of ranibizumab in the treatment of wet AMD, and the postulated similarity between the disease mechanisms involved in both wet AMD and PCV, we believe ranibizumab will have a beneficial effect on visual function in patients with PCV.
Key Dates
- First listed
- Feb 5, 2009
- Start date
- May 31, 2006
- Status verified
- Apr 2019
- Primary completion
- Dec 31, 2010
- Completion
- Dec 31, 2010
Study Design
- Enrollment
- 20 participants (actual)
- Allocation
- NON_RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: Ranibizumab 0.5 mg/ 0.05 ccIntraocular injection of 0.5 mg/ 0.05 cc ranibizumab
- Experimental: Ranibizumab 0.3 mg/ 0.05 ccIntraocular injection of 0.3 mg/ 0.05 cc ranibizumab
Primary Outcome Measure
Commonly Reported and Notable Adverse Events [ Time Frame: 2 years ]
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Southeast Retina Center | Augusta | Georgia | 30909 | - |
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