US-based Allegro Ophthalmics has started patient enrolment in Phase II trial designed to evaluate the safety and efficacy of Luminate, previously known as ALG-1001, in patients with diabetic macular edema (DME).
The company is focused on establishing Integrin Peptide Therapy as the next-generation pharmaceutical category to treat vitreo-retinal diseases.
The randomised, controlled, double-masked, multi-centre, dose-ranging Phase II trial will assess the safety and efficacy of intravitreal injections of Luminate compared to the current standard of care for DME patients.
During the trial, patients will be given one of five treatment groups that include three Luminate groups (1mg, 2mg, or 3mg), a bevacizumab (Genentech) group, and a focal laser photocoagulation group.
A total of 150 patients will be enrolled in the trial and they will return for examinations every four weeks for six months.
Allegro Scientific Advisory Board member and USC/Keck School of Medicine clinical professor of Ophthalmology David Boyer said: "I’m pleased to be participating in this important study which has the potential to benefit the millions of diabetics who are at risk of losing their vision.
"There is a significant need to find better treatment options that reduce the number of intravitreal injections, while helping a larger patient population.
"In clinical studies to date, Luminate has been shown to be effective as monotherapy treatment to meaningfully reduce the burden of intravitreal injections, while also providing a clinical benefit for those patients who either don’t respond to anti-VEGF therapy or plateau with less than excellent vision."
Luminate is a first-in-class Integrin Peptide therapy that treats vitreo-retinal diseases by targeting integrin receptors involved in cell signalling and regulation, and in the construction of new and aberrant blood vessels.
Allegro Ophthalmics chief technical officer Vicken Karageozian said: "This Phase II clinical study design follows the prospective analysis of the Phase I DME study, which demonstrated strong safety and efficacy in monotherapy treatment with Luminate.
"In the Phase I study, eight of 15 end-stage DME patients treated with Luminate experienced a three to five line improvement in visual acuity with a corresponding improvement in macular anatomy as measured three months off treatment."
Image: Diabetic macular edema. Photo: courtesy of National Eye Institute, National Institutes of Health.