Neovascular Age Related Macular Degeneration Clinical Trial
Official title:
Phase II Study of the Efficacy and Safety of Squalamine Lactate Ophthalmic Formulation 0.2% BID in Subjects With Neovascular AMD.
The purpose of this study is to evaluate the safety and efficacy of topical ophthalmic squalamine lactate eye drops in treating patients with neovascular age-related macular degeneration (wet AMD), a degenerative retinal eye disease that causes a progressive, irreversible, severe loss of central vision.
Age-related macular degeneration (AMD) is a degenerative retinal eye disease 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 and affects 25-30 million people globally. This number
is expected to triple over the next 25 years. Central vision loss from AMD is caused by the
degeneration of light-sensing cells in the macula called photoreceptors. The macula, the
central portion of the retina, is responsible for perceiving fine visual detail. As
photoreceptors begin to degenerate, so does the individual's central vision. The extent of
vision loss varies widely and is related to the type of AMD, its severity and other
individual characteristics.
AMD presents itself in two different forms — a "dry" form and the more severe "wet" form.
Dry AMD, the more common and milder form of AMD, accounts for 85% to 90% of all cases. It
results in varying forms of sight loss and may or may not eventually develop into the wet
form. Although the wet form of AMD accounts for only 10% to 15% of all AMD, the chance for
severe sight loss is much greater. Wet AMD is responsible for 90% of severe vision loss
associated with AMD. Approximately 500,000 new cases of wet AMD are diagnosed annually
worldwide. In North America alone, approximately 200,000 new cases of wet AMD are diagnosed
each year.
Squalamine lactate has been found to be an inhibitor of new blood vessel formation
(angiogenesis) induced by VEGF, PDGF or bFGF. Since angiogenesis is implicated in the growth
and maintenance of choroidal neovascularization, squalamine lactate is potentially an
attractive development candidate in the treatment of age-related macular degeneration (AMD),
in which blood vessel proliferation has a role.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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