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Home » GENAERA INITIATES PHASE III MACULAR DEGENERATION TRIAL
GENAERA INITIATES PHASE III MACULAR DEGENERATION TRIAL
July 5, 2005
Genaera has initiated the first of two planned global Phase III clinical trials (MSI-1256F-301) of its systemically administered anti-angiogenic drug, Evizon (squalamine lactate), for the treatment of "wet" age-related macular degeneration (AMD).
The identical international Phase III studies will enroll subjects with predominantly classic, minimally classic and occult forms of wet AMD. Each study will be a multi-center, randomized, double-masked, controlled trial and will evaluate two systemically-administered doses of Evizon (40mg and 20 mg) versus placebo, dosed weekly for four weeks followed by maintenance doses every four weeks until Week 104.
Photodynamic therapy with QLT's Visudyne will be allowed for all subjects if deemed necessary by the study physician. The total number of subjects enrolled into each Phase III study will be based upon analyses of data from the company's existing and ongoing Phase II clinical trials, as agreed upon with the FDA. Genaera anticipates launching its second Phase III trial (MSI-1256F-302) in the second half of the year.
The primary objectives of these studies are to demonstrate safety and significant clinical benefit of Evizon therapy on visual acuity at one year in the study eye. Planned secondary analyses include evaluation of changes in visual acuity from baseline in the study eye at year two and change in visual acuity in fellow eyes affected with wet AMD and quality of life at years one and two.
KEYWORDS Drug Pipeline Alert
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