A Study Using Intravitreal Injections of a Small Interfering RNA in Patients With Age-Related Macular Degeneration

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

138 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-01-31

Study Completion Date

2009-02-28

Brief Summary

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This is a 24-month study to evaluate multiple doses of AGN211745 (previously known as Sirna-027) in treatment of subfoveal choroidal neovascularization associated with age-related macular degeneration

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Detailed Description

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Conditions

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Choroid Neovascularization Age-Related Macular Degeneration

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

AGN 211745 Solution 1000µg injection at Day 1, Month 1, Month 2

Intervention Type DRUG

AGN 211745

AGN 211745 Solution 300µg injections, Day 1, Month 1, Month 2

Intervention Type DRUG

AGN 211745

AGN 211745 Solution 100µg injections, Day 1, Month 1, Month 2

Intervention Type DRUG

Ranibizumab 500µg

Ranibizumab 500µg injections at Day 1, Month 1, Month 2

Intervention Type DRUG

Other Intervention Names

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Sirna-027 Sirna-027 Sirna-027 Lucentis®

Eligibility Criteria

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Inclusion Criteria

* 50 years or older with "wet" AMD as determined by an ophthalmologist
* decrease in visual acuity (20/40 to 20/640) in at least one eye

Exclusion Criteria

* Uncontrolled systemic disease
* History of heart attack or stroke within one year of study entry
* Symptomatic coronary artery disease
* Cataracts that interfere with vision

Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No