Phase 2 Study of an Ocular Sirolimus (Rapamycin) Formulation in Combination With Lucentis® in Patients With Age-Related Macular Degeneration
| Status: | Terminated |
|---|---|
| Conditions: | Cardiology, Ocular |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Ophthalmology |
| Healthy: | No |
| Age Range: | 50 - Any |
| Updated: | 10/14/2017 |
| Start Date: | December 2008 |
| End Date: | March 2010 |
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
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.
(rapamycin) formulation in combination with Lucentis in patients with sub-foveal choroidal
neovascularization secondary to age-related macular degeneration.
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
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