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Sponsored by: |
Genaera Corporation |
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Information provided by: | Genaera Corporation |
ClinicalTrials.gov Identifier: | NCT00139282 |
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.
Condition | Intervention | Phase |
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"Wet" Age-Related Macular Degeneration |
Drug: Squalamine Lactate |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Phase 3, Multicenter, Randomized, Double-Masked, Controlled Study of Squalamine Lactate (MSI-1256F) for Injection for the Treatment of Subfoveal Choroidal Neovascularization Associated With Age-Related Macular Degeneration |
Study Start Date: | June 2005 |
Ages Eligible for Study: | 50 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study ID Numbers: | MSI-1256F-301 |
Study First Received: | August 29, 2005 |
Last Updated: | November 27, 2007 |
ClinicalTrials.gov Identifier: | NCT00139282 |
Health Authority: | United States: Food and Drug Administration |
wet AMD macular degeneration |
Squalamine Metaplasia Eye Diseases Choroid Diseases Retinal Degeneration |
Macular Degeneration Neovascularization, Pathologic Retinal Diseases Retinal degeneration Choroidal Neovascularization |
Anticarcinogenic Agents Anti-Infective Agents Uveal Diseases Antineoplastic Agents Growth Substances Physiological Effects of Drugs Protective Agents |
Angiogenesis Inhibitors Pharmacologic Actions Anti-Bacterial Agents Pathologic Processes Therapeutic Uses Growth Inhibitors Angiogenesis Modulating Agents |