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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00712491
Other study ID # AMD-002
Secondary ID
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
Health authority
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

Study Design


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
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