Status:
TERMINATED
Phase 2 Study of an Ocular Sirolimus (Rapamycin) Formulation in Combination With Lucentis® in Patients With Age-Related Macular Degeneration
Lead Sponsor:
Santen Inc.
Collaborating Sponsors:
MacuSight, Inc.
Conditions:
Age-Related Macular Degeneration
Choroidal Neovascularization
Eligibility:
All Genders
50+ years
Phase:
PHASE2
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 s...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2010
Estimated Enrollment :
62 Patients enrolled
Trial Details
Trial ID
NCT00766337
Start Date
December 1 2008
End Date
March 1 2010
Last Update
January 10 2013
Active Locations (1)
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1
Retinal Consultants of Arizona
Phoenix, Arizona, United States, 85014