PeriOcular & Intravitreal Corticosteroids for Uveitic Macular Edema (POINT) Trial (16-EI-0102)

National Eye Institute

Investigators

Abstract

Macular edema is the most common structural complication and leading cause of visual loss in patients with uveitis. Regional injections of corticosteroids are the most frequently used treatments specifically for uveitic macular edema but there is a lack of high quality evidence to guide choice of drug (e.g., triamcinolone acetonide, dexamethasone) and route of administration (e.g. periocular, intravitreal). The question of how to approach regional treatment of uveitic macular edema is a key question for ophthalmologists treating these patients. The Periocular and Intravitreal Corticosteroids for Uveitic Macular Edema (POINT) Trial is a randomized trial designed to compare the relative efficacy of three regional corticosteroids commonly utilized for the initial regional treatment of uveitic macular edema, periocular triamcinolone (Kenalog , Bristol-Myers Squibb Company, Princeton, NJ), intravitreal triamcinolone (Triesence, Alcon Pharmaceuticals, Fort Worth, TX), and the intravitreal dexamethasone implant (Ozurdex, Allergan, Irvine CA). The design outcome is the percent change in central subfield macular thickness on OCT from baseline to the 8 week visit. Follow-up through 24 weeks will allow evaluation of the duration of response and the need for additional injections. Secondary outcomes include resolution of macular edema, IOP elevation, visual acuity, complications of treatment, and cost-effectiveness. Additionally, the NEI site will explore and characterize exosome characteristics among patients with uveitic CME and evaluate whether exosomes change following ocular injections.