Macular Degeneration Clinical Trial
Official title:
A Phase I/II Controlled Dose-escalating Trial to Establish the Baseline Safety and Efficacy of a Single Subretinal Injection of rAAV.sFlt-1 Into Eyes of Patients With Exudative Age-related Macular Degeneration (AMD)
The study will involve approximately 40 subjects aged 55 or above who have exudative age-related macular degeneration (wet AMD). Patients will be randomized to receive one of two doses of rAAV.sFlt-1 or assigned to the control group.
A new treatment for exudative age-related macular degeneration (wet AMD) is being
investigated. The purpose of this Phase I/II clinical research study is to examine the
baseline safety and efficacy of an experimental study drug to treat a complication of the
disease which leads to vision loss. The name of the study drug is rAAV.sFlt-1.
This experimental study uses a non-pathogenic virus to express a therapeutic protein within
the eye. The therapeutic diminishes the growth of abnormal blood vessels under the retina.
The duration of effect is thought to be long-term (years) following a single administration.
The clinical research study will look at the baseline safety and efficacy of a single
injection of rAAV.sFlt-1 injected directly into the eye.
Approximately forty (40) subjects will participate in Australia. The primary endpoint of the
study is at one month, with extended follow up for 3 years.
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