Age-related Macular Degeneration Clinical Trial
Official title:
A Phase 1/2, Randomized Clinical Study to Assess the Safety and Efficacy of Sirolimus in Patients With Newly Diagnosed, Treatment-Naive Sub-Foveal Choroidal Neovascularization Secondary to Age-Related Macular Degeneration
Verified date | July 2010 |
Source | Santen Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to determine the safety and efficacy of an ocular sirolimus (rapamycin) formulation via different injection routes in patients with treatment-naive sub-foveal choroidal neovascularization secondary to age-related macular degeneration.
Status | Terminated |
Enrollment | 20 |
Est. completion date | March 2010 |
Est. primary completion date | November 2009 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 50 Years and older |
Eligibility |
Inclusion Criteria include, but are not limited to: - Diagnosed with sub-foveal choroidal neovascularization secondary to age-related macular degeneration - Visual acuity of 20/50 to 20/200 in study eye Exclusion Criteria: - Any other ocular disease that could compromise vision in the study eye - History of any prior treatment for choroidal neovascularization in the study eye - Presence of other causes of choroidal neovascularization other than secondary to age-related macular degeneration |
Country | Name | City | State |
---|---|---|---|
United States | Retinal Consultants of Arizona | Phoenix | Arizona |
Lead Sponsor | Collaborator |
---|---|
Santen Inc. | MacuSight, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Best-corrected visual acuity by ETDRS | 180 days | ||
Secondary | Best-corrected visual acuity by ETDRS | 60 days, 120 days | ||
Secondary | Safety across injection routes | Through 1 year |
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