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

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ClinicalTrials.gov Identifier: NCT00089830
Recruitment Status : Terminated
First Posted : August 17, 2004
Last Update Posted : November 28, 2007
Sponsor:
Information provided by:

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Macular Degeneration Drug: MSI-1256F (Squalamine Lactate) Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Study Start Date : August 2004
Study Completion Date : May 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions


Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Prior treatment of "wet" age-related macular degeneration in the affected eye in the past 3 months
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00089830


Locations
United States, Pennsylvania
Genaera Corporation
Plymouth Meeting, Pennsylvania, United States, 19462
Sponsors and Collaborators
Genaera Corporation
More Information

ClinicalTrials.gov Identifier: NCT00089830     History of Changes
Other Study ID Numbers: MSI-1256F-209
First Posted: August 17, 2004    Key Record Dates
Last Update Posted: November 28, 2007
Last Verified: November 2007

Keywords provided by Genaera Corporation:
Subfoveal Choroidal Neovascularization
Squalamine Lactate

Additional relevant MeSH terms:
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Squalamine
Anti-Bacterial Agents
Anti-Infective Agents
Anticarcinogenic Agents
Protective Agents
Physiological Effects of Drugs
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors