Short-term results of intravitreal dexamethasone implant (OZURDEX(®)) in treatment of recalcitrant diabetic macular edema: A case series

Abstract

Context: Dexamethasone Posterior-Segment Drug Delivery System is a novel, biodegradable, sustained-release drug delivery system (OZURDEX(®)) for treatment of macular edema following retinal vein occlusion and posterior uveitis. However, its potential role in management of diabetic macular edema has not been reported yet.

Aim: The aim was to evaluate the safety and efficacy of (OZURDEX(®)) in patients with recalcitrant diabetic macular edema (DME).

Setting and design: A retrospective, interventional case series from a tertiary eye care center in India is presented. Inclusion criteria comprised patients presenting with recalcitrant DME, 3 or more months after one or more treatments of macular laser photocoagulation and/or intravitreal anti-vascular endothelial growth factor (VEGF) injections. Exclusion criteria included history of corticosteroid-responsive intraocular pressure (IOP) rise, cataract extraction, or other intraocular surgery within 3 months. The main outcome measure was visual acuity at 1 and 4 months after OZURDEX(®) injection. Secondary outcome measures included change in central macular thickness on Optical coherence tomography (OCT) and changes in IOP following intravitreal OZURDEX(®) implant. Of 18 eyes (17 patients) with recalcitrant diabetic macular edema that underwent OZURDEX(®) implant, three eyes (two patients) had follow-up of more than 3 months post-injection.

Results: Mean age of patients was 56 years. Mean duration of diabetes mellitus was 16.6 years. Systemic control of DM was good as assessed by FBS/PPBS and HbA1c. The pre-operative mean central macular thickness was 744.3 μm and improved to 144 and 570 μm at months 1 and 4, respectively. Preoperative mean BCVA was 0.6 logMAR units and improved to 0.3 and 0.46 logMAR units at month 1 and 4, respectively. The mean follow-up was 4.3 months (range 4-5 months).

Conclusion: OZURDEX(®) appears efficacious in management of recalcitrant diabetic macular edema. The results of the ongoing POSURDEX(®) study will elaborate these effects better.

Keywords: Dexamethasone; OZURDEX®; diabetes mellitus; diabetic macular edema; intravitreal implant.

Figure 1

Case 1, baseline. (a) color fundus photo of right eye reveals multiple retinal hemorrhages, hard exudates and increased macular thickness. (b) arteriovenous phase of fluorescein angiography (FA) reveals multiple areas of pinpoint hyperfluorescence corresponding to leaking retinal microaneurysms. (c) OCT scan shows increased macular thickness with multiple intraretinal cystoid spaces (536 μm)

Figure 2

Case 1. (a) OCT scan at 1 month follow-up shows near-complete resolution of macular edema and restored foveal contour (228 μm). (b) OCT scan at 3-month follow-up shows rebound macular edema with increased macular thickness, intraretinal cystoid spaces (340 μm)