US-based biotechnology company Allegro Ophthalmics has completed enrolment in its PACIFIC Phase IIb clinical trial of Luminate (ALG-1001) in resulting posterior vitreous detachment (PVD) within patients with non-proliferative diabetic retinopathy (DR).
Luminate has been developed as an integrin peptide therapy, which treats vitreoretinal diseases by targeting integrin receptors considered responsible for cell signalling and regulation and in the construction of new and aberrant blood vessels.
It uses two mechanisms of action known as vitreolysis and anti-angiogenesis to control and inhibit new blood vessel formation, while reducing vascular leakage to maintain and restore vision.
The PACIFIC Phase IIb double-masked, placebo-controlled, randomised, multi-centre, dose-ranging trial intends to test the intravitreal injections of Luminate in patients with non-proliferative DR.
The study has enrolled 100 patients who were divided into five treatment groups, out of which four groups received Luminate and the other were administered with a balanced salt solution (BSS) placebo.
The study was primarily focused on PVD induction, based on optical coherence tomography and / or B-scan ultrasound.
Allegro scientific advisory board member and study investigator Baruch Kuppermann said: “PACIFIC is an important study that will broaden and confirm our understanding of this non-surgical option for patients with mild-to-moderate, non-proliferative diabetic retinopathy who may potentially proceed to vision-threatening disease over time.
“There is a significant body of evidence that suggests inducing a PVD may inhibit the progression of retinal disease. An early Phase I trial has already demonstrated that Luminate can induce PVD in patients with DME.”
Luminate is currently undergoing Phase II clinical trials for multiple indications such as diabetic macular edema (DME) and non-proliferative diabetic retinopathy (NPDR).
Image: Image depicting scatter laser surgery for diabetic retinopathy. Photo: courtesy of National Eye Institute, National Institutes of Health.