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

NCT ID: NCT00712491

Last Updated: 2013-01-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-09-30

Study Completion Date

2010-03-31

Brief Summary

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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

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Conditions

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Age-related Macular Degeneration Choroidal Neovascularization

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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1

Group Type EXPERIMENTAL

Sirolimus

Intervention Type DRUG

Three subconjunctival injections of 1320 micrograms sirolimus each.

2

Group Type EXPERIMENTAL

Sirolimus

Intervention Type DRUG

Three intravitreal injections of 352 micrograms sirolimus each.

Interventions

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Sirolimus

Three subconjunctival injections of 1320 micrograms sirolimus each.

Intervention Type DRUG

Sirolimus

Three intravitreal injections of 352 micrograms sirolimus each.

Intervention Type DRUG

Other Intervention Names

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MS-R002, rapamycin MS-R001, rapamycin

Eligibility Criteria

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Inclusion Criteria

* 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
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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MacuSight, Inc.

INDUSTRY

Sponsor Role collaborator

Santen Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Joel Naor, MD

Role: STUDY_DIRECTOR

MacuSight, Inc.

Locations

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Retinal Consultants of Arizona

Phoenix, Arizona, United States

Site Status

Countries

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United States

Other Identifiers

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AMD-002

Identifier Type: -

Identifier Source: org_study_id

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