Category: Clinical

Month: 02 Nov 2014

Issue: not yet available

Phase II study initiated with novel anti-integrin compound for the treatment of diabetic macular edema (DME)

A new Phase II clinical trial based in the US has been commenced to compare three separate doses of intravitreal ALG-1001 (“Luminate”) against bevacizumab or focal laser photocoagulation to treat diabetic macular edema (DME) in approximately150 patients. According to the sponsor of the study, Allegro Ophthalmics Inc based in Chicago, Illinois, the study will be a randomized, controlled, double-masked, multi-center, dose-ranging trial to evaluate the safety and efficacy of intravitreal injections of ALG1001 to the current “standard of care for patients with DME”. Patients will be randomized to one of five treatment groups that include three doses of ALG1001 (1.0 mg, 2.0 mg, or 3.0 mg), a bevacizumab (Genentech) group, and a focal laser photocoagulation group. All 150 patients are expected to return for examinations every four weeks for six months.

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