Phase 2 Study of an Ocular Sirolimus (Rapamycin) Formulation in Combination With Lucentis® in Patients With Age-Related Macular Degeneration
Phase 2
Terminated
- Conditions
- Age-Related Macular DegenerationChoroidal Neovascularization
- Interventions
- Drug: Placebo in combination with ranibizumab
- Registration Number
- NCT00766337
- Lead Sponsor
- Santen Inc.
- Brief Summary
The purpose of this study is to determine the safety and efficacy of an ocular sirolimus (rapamycin) formulation in combination with Lucentis in patients with sub-foveal choroidal neovascularization secondary to age-related macular degeneration.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 62
Inclusion Criteria
- Diagnosed with sub-foveal choroidal neovascularization secondary to age-related macular degeneration within six months of initial study visit, and may have been treated with up to 3 Lucentis® (ranibizumab) or 3 Avastin® (bevacizumab) injections with the last injection administered at least 4 weeks prior to the initial study visit, or is treatment-naïve
- Visual acuity of 20/40 to 20/200 in the study eye
Exclusion Criteria
- Any other ocular disease that could compromise vision in the study eye
- Presence of other causes of choroidal neovascularization other than secondary to age-related macular degeneration
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Dose Group 2 Sirolimus in combination with ranibizumab - Dose Group 3 Placebo in combination with ranibizumab - Dose Group 1 Sirolimus in combination with ranibizumab -
- Primary Outcome Measures
Name Time Method Best-corrected visual acuity by ETDRS 120 days
- Secondary Outcome Measures
Name Time Method Safety across treatment groups Through 2 years Retinal thickness 120 days
Trial Locations
- Locations (1)
Retinal Consultants of Arizona
🇺🇸Phoenix, Arizona, United States