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A Study of MSI-1256F (Squalamine Lactate) To Treat "Wet" Age-Related Macular Degeneration

NCT ID: NCT00333476

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

PHASE2

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-05-31

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 legal 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 test the safety and efficacy of Squalamine in the treatment of AMD.

Detailed Description

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Conditions

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Macular Degeneration

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Interventions

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MSI-1256F (Squalamine Lactate)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Adult subjects ≥ 50 years of age.
* minimally classic or active occult choroidal neovascularization associated with age-related macular degeneration in one or both eyes.
* baseline best corrected visual acuity score between 35 to 65 letters according to the Early Treatment of Diabetic Retinopathy Study protocol.
* central retinal thickness by optical coherence tomography of \> 250 microns.
* lesions \> 9 disc areas.
* \> 25% fibrosis in the lesion.

Exclusion Criteria

* Previous history of triamcinolone, bevacizumab, ranibizumab, or pegaptanib sodium injection therapy in the study eye.
* retinal or optic nerve disease.
* uncontrolled diabetes.
* ongoing malignancy.
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Genaera Corporation

INDUSTRY

Sponsor Role lead

Principal Investigators

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Randy Katz, MD

Role: PRINCIPAL_INVESTIGATOR

Florida Eye Microsurgical Institute, Inc.

Alexander Eaton, MD

Role: PRINCIPAL_INVESTIGATOR

Retina Health Center

Thomas Ciulla, MD

Role: PRINCIPAL_INVESTIGATOR

Midwest Eye Institute

Raymond Sjaarda, MD

Role: PRINCIPAL_INVESTIGATOR

Retina Specialists

Nelson Sabates, MD

Role: PRINCIPAL_INVESTIGATOR

Eye Foundation of Kansas City

Charles Garcia, MD

Role: PRINCIPAL_INVESTIGATOR

Charles Garcia, MD, P.A.

Glenn Stoller, MD

Role: PRINCIPAL_INVESTIGATOR

Ophthalmic Consultants of Long Island

Phillip Rosenfeld, MD

Role: PRINCIPAL_INVESTIGATOR

Bascom Palmer Eye Institute

Steven Rose, MD

Role: PRINCIPAL_INVESTIGATOR

Retina Associates of Western New York

Locations

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Florida Eye Microsurgical Institute

Boynton Beach, Florida, United States

Site Status

Retina Health Center

Fort Meyers, Florida, United States

Site Status

Bascom Palmer Eye Institute

Miami, Florida, United States

Site Status

Midwest Eye Institute

Indianapolis, Indiana, United States

Site Status

Retina Specialists

Towson, Maryland, United States

Site Status

Eye Foundation of Kansas City

Kansas City, Missouri, United States

Site Status

Ophthalmic Consultants of Long Island

Long Island City, New York, United States

Site Status

Retina Associates of Western New York

Rochester, New York, United States

Site Status

Charles Garcia, MD, P.A.

Houston, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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MSI-1256F-212

Identifier Type: -

Identifier Source: org_study_id