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A Safety and Efficacy Study of Squalamine Lactate for Injection (MSI-1256F) for "Wet" Age-Related Macular Degeneration

NCT ID: NCT00139282

Last Updated: 2007-11-28

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

PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2005-06-30

Brief Summary

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Age-Related Macular Degeneration (AMD) is a degenerative eye disease of the retina that causes a progressive loss of central vision. AMD is the leading cause of blindness among adults age 50 or older in the Western world. AMD presents in two different types: "dry" and the more severe "wet" form. Wet AMD is caused by the growth of abnormal blood vessels in the macula. Squalamine lactate is an investigational drug that may prevent the growth of these abnormal blood vessels. This study will evaluate the safety and efficacy of Squalamine lactate in the treatment of AMD in patients, the exact number of which will be determined based on data from the sponsor's ongoing Phase 2 trials.

The trial objective is to evaluate the safety and efficacy of two doses of Squalamine lactate for Injection administered as intravenous infusions weekly for 4 weeks followed by maintenance doses every 4 weeks through week 104 compared with the safety and efficacy in the control group.

Detailed Description

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Conditions

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"Wet" Age-Related Macular Degeneration

Keywords

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wet AMD macular degeneration

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Squalamine Lactate

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients with a diagnosis of "wet" age-related macular degeneration

Exclusion Criteria

* Prior treatment for "wet" age-related macular degeneration in the affected eye in the past 3 months
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Genaera Corporation

INDUSTRY

Sponsor Role lead

Locations

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Retina-Vitreous Associates Medical Group

Beverly Hills, California, United States

Site Status

Eldorado Retina Associates

Louisville, Colorado, United States

Site Status

Florida Eye Microsurgical Institute

Boynton Beach, Florida, United States

Site Status

National Ophthalmic Research Institute

Fort Myers, Florida, United States

Site Status

University of Florida

Jacksonville, Florida, United States

Site Status

Magruder Eye Institute

Orlando, Florida, United States

Site Status

East Florida Eye Institute

Stuart, Florida, United States

Site Status

Retina Associates of Florida

Tampa, Florida, United States

Site Status

Center for Retina and Macular Disease

Winter Haven, Florida, United States

Site Status

Midwest Eye Institute

Indianapolis, Indiana, United States

Site Status

Retina Associates, PA

Shawnee Mission, Kansas, United States

Site Status

Cumberland Valley Retina Consultants, PC

Hagerstown, Maryland, United States

Site Status

Delaware Valley Retina Associates

Lawrenceville, New Jersey, United States

Site Status

Retina Associates of New Jersey

Teaneck, New Jersey, United States

Site Status

MaculaCare

New York, New York, United States

Site Status

Charlotte Eye, Ear, Nose & Throat Associates

Charlotte, North Carolina, United States

Site Status

Horizon Eye Care

Charlotte, North Carolina, United States

Site Status

The Ohio State University, Havener Eye Institute

Columbus, Ohio, United States

Site Status

Penn State Ophthalmology

Hershey, Pennsylvania, United States

Site Status

Retina Vitreous Consultants

Pittsburgh, Pennsylvania, United States

Site Status

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

Site Status

Genaera Corporation

Plymouth Meeting, Pennsylvania, United States

Site Status

Carolina Retina Center

Columbia, South Carolina, United States

Site Status

Black Hills Regional Eye Institute

Rapid City, South Dakota, United States

Site Status

Southeastern Retina Associates

Kingsport, Tennessee, United States

Site Status

Retina Research Center

Austin, Texas, United States

Site Status

Garcia & Associates, MD, PA

Houston, Texas, United States

Site Status

John Moran Eye Center

Salt Lake City, Utah, United States

Site Status

Virginia Retina Center

Leesburg, Virginia, United States

Site Status

Countries

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United States

Other Identifiers

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MSI-1256F-301

Identifier Type: -

Identifier Source: org_study_id