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

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

Status

Terminated

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00712491

Enrollment

Registered

2008-07-10

Start date

2008-09-30

Completion date

2010-03-31

Last updated

2013-01-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Age-related Macular Degeneration, Choroidal Neovascularization

Keywords

wet AMD, CNV

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.

Interventions

DRUGSirolimus

Three subconjunctival injections of 1320 micrograms sirolimus each.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

50 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Best-corrected visual acuity by ETDRS	180 days

Secondary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026