NCT00766337
Terminated
Phase 2
A Phase 2, Randomized, Masked, Controlled Clinical Study to Assess the Safety and Efficacy of Lucentis® Plus Sirolimus Versus Lucentis® Plus Placebo in Patients With Sub-Foveal Choroidal Neovascularization Secondary to Age-Related Macular Degeneration
Overview
- Phase
- Phase 2
- Intervention
- Sirolimus in combination with ranibizumab
- Conditions
- Age-Related Macular Degeneration
- Sponsor
- Santen Inc.
- Enrollment
- 62
- Locations
- 1
- Primary Endpoint
- Best-corrected visual acuity by ETDRS
- Status
- Terminated
- Last Updated
- 13 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
Dose Group 1
Intervention: Sirolimus in combination with ranibizumab
Dose Group 2
Intervention: Sirolimus in combination with ranibizumab
Dose Group 3
Intervention: Placebo in combination with ranibizumab
Outcomes
Primary Outcomes
Best-corrected visual acuity by ETDRS
Time Frame: 120 days
Secondary Outcomes
- Safety across treatment groups(Through 2 years)
- Retinal thickness(120 days)
Study Sites (1)
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