Assessing the safety and efficacy of dexamethasone intraocular implant for macular edema after cataract surgery in patients with diabetes.

Abstract

Purpose : To evaluate the safety and efficacy of dexamethasone sustained release 0.7mg intravitreal implant (DEX implant, OZURDEX) in treating macular edema (ME) following cataract surgery in patients with diabetes.

Methods : We conducted a prospective, randomized study. 39 patients were enrolled over a study duration of 3.5 months. Eligible study participants were at least 18 years old, had a diagnosis of DM I or II, and developed macular edema following cataract surgery. Patients were randomized (2:1) into either DEX implant group or topical Prednisolone and Ketorolac group. Primary endpoints included change in best-corrected visual acuity and central retinal thickness (by OCT).

Results : 28 patients were enrolled in the DEX implant arm and 11 were enrolled in the topical drops arm. Treatment was initiated at the baseline visit and patients were followed monthly for 3 months. No major differences in baseline characteristics existed. Both groups had similar improvements in visual acuity at the end of follow-up (5.7 vs 5.2 letters in DEX and topical arms, respectively (p=0.26)). 18 (69%) and 9 (82%) patients in the DEX and topical arms, respectively, achieved 20/40 or better acuity at the end of follow-up (p=0.43). Central retinal thickness reduction was significantly greater in the DEX arm at month 1 (-115.3 vs -42.7um, p<0.01) and 2 (-131.8 vs -67.5um, p<0.01) but was not sustained in month 3 (-83.5 vs -62.4um, P=0.22). One patient in the Dex arm had elevated IOP >30mm Hg. This was controlled with topical drops. No serious adverse events were seen in either arm.

Conclusions : A single DEX implant injection had significantly greater reduction of the central retinal thickness compared to topical treatment over the first 2 months. This treatment effect was not able to maintained at month 3, however. Regardless of treatment group, both arms achieved similar gains in vision and the majority in both groups had >20/40 acuity.

This is an abstract that was submitted for the 2017 ARVO Annual Meeting, held in Baltimore, MD, May 7-11, 2017.