Phase 1/2 Study of an Ocular Sirolimus (Rapamycin) Formulation in Patients With Age-Related Macular Degeneration

Phase 1

Terminated

• Conditions: Choroidal Neovascularization; Age-related Macular Degeneration
• Interventions: Drug: Sirolimus

• Registration Number: NCT00712491
• Lead Sponsor: Santen Inc.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-07-08
• Study First Submitted QC: 2008-07-08
• Study First Posted: 2008-07-10
• Study Start: 2008-09
• Primary Completion: 2009-11
• Study Completion: 2010-03
• Status Verified: 2010-07
• Last Update Submitted: 2013-01-08
• Last Update Posted: 2013-01-10

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Not provided

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Sirolimus	-
2	Sirolimus	-

Primary Outcome Measures

Name	Time	Method
Best-corrected visual acuity by ETDRS	180 days

Secondary Outcome Measures

Name	Time	Method
Best-corrected visual acuity by ETDRS	60 days, 120 days
Safety across injection routes	Through 1 year

Trial Locations

Locations (1)

Retinal Consultants of Arizona; 🇺🇸 Phoenix, Arizona, United States