Clinical Updates — Clinical Updates

Allegro Begins Phase 2 Trial of Luminate for DME

Allegro Ophthalmics, LLC has is now enrolling patients with diabetic macular edema (DME) for a phase 2 trial to evaluate the safety and efficacy of Luminate, previously known as ALG-1001.

The phase 2 study is a randomized, controlled, double-masked, multicenter, dose-ranging trial to evaluate the safety and efficacy of intravitreal Luminate compared to current standard of care for DME patients. Patients will be randomized to 1 of 5 treatment groups: Luminate (1.0 mg, 2.0 mg, or 3.0 mg), bevacizumab, and focal laser photocoagulation. Participants will be examined every 4 weeks for 6 months, and the total planned enrollment is 150 patients.

Luminate treats vitreoretinal diseases by targeting integrin receptors involved in cell signaling and regulation and in the construction of new and aberrant blood vessels. By utilizing anti-angiogenesis and vitreolysis, it has been shown to be effective at regressing and inhibiting new blood vessel formation and reducing vascular leakage.

Updated October 16, 2014