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

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00712491
• Other study ID #: AMD-002
• Status: Terminated
• Phase: Phase 1/Phase 2
• First received: July 8, 2008
• Last updated: January 8, 2013
• Start date: September 2008
• Est. completion date: March 2010

Study information

• Verified date: July 2010
• Source: Santen Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Age-related Macular Degeneration
• Choroidal Neovascularization
• Macular Degeneration
• Neovascularization, Pathologic

Intervention

Drug:
• Sirolimus
Three subconjunctival injections of 1320 micrograms sirolimus each.
• Sirolimus
Three intravitreal injections of 352 micrograms sirolimus each.

Locations

Country	Name	City	State
United States	Retinal Consultants of Arizona	Phoenix	Arizona

Sponsors (2)

Lead Sponsor	Collaborator
Santen Inc.	MacuSight, Inc.

Country where clinical trial is conducted

United States, 

Outcome

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