drugset / Trial / NCT02865031

Dacorin for Proliferative Vitreoretinopathy

NCT02865031

Phase 1/2 Completed 15 enrolled Cairo University
NaSingle-groupOpen-labelPrevention

Summary

Purpose: To determine the safety, tolerability, and efficacy of human recombinant decorin protein, a transforming growth factor ß (TGFß) inhibitor in preventing proliferative vitreoretinopathy (PVR) in patients with perforating globe injuries. Methods: This is a prospective, single-center, open-label, interventional case series. A single intravitreal injection of decorin 200ug (n=4) and 400ug (n=8) was given within 24 hours of injury. Pars plana vitrectomy with silicone oil injection was done if indicated. ERG was done before injections, at day 10, and 3 months. Serial plasma decorin levels were assessed before injections, day 3, 5, and 10 post-injection. Clinical assessment included globe survival, retinal attachment rate, and PVR evaluation.

Timeline

Start
2015-08
Primary completion
2016-07
Completion
2016-08

Drugs

EvaluationDrugModalityDoseRoute
Subject Decorin Protein / enzyme biologic 200 ug Intravitreal
Subject Decorin Protein / enzyme biologic 400 ug Intravitreal