EVALUATION OF THE SAFETY AND PERFORMANCE OF AN APPLICATOR FOR A NOVEL INTRAVITREAL DEXAMETHASONE DRUG DELIVERY SYSTEM FOR THE TREATMENT OF MACULAR EDEMA

Purpose: Evaluation of safety and performance of an applicator-inserted dexamethasone drug delivery system. Methods: Patients with clinically observable macular edema were randomized to receive 700 mu g dexamethasone drug delivery system via a pars plana incisional placement (n = 10) or a 22-gauge applicator insertion (n = 20). Outcome measures included assessment of procedure duration, the postinsertion wound, adverse events, intraocular pressure, and best-corrected visual acuity at baseline and days 1, 7, 14, 30, 60, 90, and 180. Results: Both procedures were well tolerated and none of the patients in the applicator group required sutures to close the insertion wound. The overall incidence of ocular adverse events was less in the applicator group (13/19; 68.4%) than the incisional group (9/10; 90%), although the difference was not statistically significant in this pilot study. Vitreous hemorrhage occurred in two patients in the incisional group and none in the applicator group. Increases in intraocular pressure were less frequent in the applicator group (3/19; 15.8%) than the incisional group (3/10; 30%). No cases of endophthalmitis or retinal detachment occurred in either group. The percentage of patients achieving improvement in visual acuity of >= 15-letters at Day 90 was similar in both groups; 40% (8/20) in the applicator group and 30% (3/10) in the incisional group. Conclusion: The dexamethasone drug delivery system applicator system performed well, allowing safe, effective, and sutureless intravitreal placement of 700 mu g dexamethasone drug delivery system.