Wet Age-Related Macular Degeneration Clinical Trial
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
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.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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