First Author: E.Mingorance Moya SPAIN
Co Author(s): M.F. Bassaganyas Vilarrasa J. Díaz Cascajosa J.I. Vela Segarra J. Crespí Vilimelis T. Marieges Jubany 0 0 0 0 0 0 0 0 0
Back to previous
To evaluate the long-term safety of Ozurdex treatment in patients with macular edema (ME) due to miscellaneous etiology, and analyze its efficacy in the retinal vein occlusion (RVO) subgroup.
Department of ophthalmology at hospital de la Santa Creu i Sant Pau, Barcelona, Spain.
Prospective study of 73 patients treated with Ozurdex between june 2011 and june 2013. The Early Treatment Diabetic Retinopathy Study (ETDRS) best corrected visual acuity (BCVA), central macular thickness (CMT) on optical coherence tomography, and intraocular pressure were measured preoperatively and thereafter; in first week, every two months during the first year and every three months during the second year post-treatment. All the adverse events were registered. In case of ME recurrence, an Ozurdex reinjection or other type of treatment (laser photocoagulation, intravitreal anti-vascular endothelial growth factor or intravitreal triamcinolone) were offered depending on the retinal physician criteria, emulating the daily clinical practice.
In 24 months the 73 included eyes received a total of 110 Ozurdex injections, with retreatments in 22 patients. Regarding the ME etiology, in 21 cases was central RVO, 16 branch RVO, 22 diabetic retinopathy, 4 Irvine-Gass syndrome, 2 uveitis, 1 age-related macular degeneration, and 7 other diagnosis. In the RVO subgroup analysis (n = 37), BCVA peaked at 2nd month, with a mean improvement of 12.24 letters (L); that decreased in 4th month. The mean VA remained stable throughout the study period, with a baseline BCVA of 44.14 L, in 12th month of 49.45 L, and in 24th month of 43.67 L. The mean reduction in CMT was –300 microns in 2nd month, -170 microns in 12th month, and –335 microns in 24th month. The 61% of patients needed a new treatment (Ozurdex or other) after the 4th month. Ozurdex reinjections showed a safety and duration profile similar to the first one, except for an accelerated cataract progression after the second treatment. As a serious complication, we recorded 1 case of endophthalmitis. The mild adverse events included 16 cases of ocular hypertension with a peak in 2nd month, successfully managed with topical medication; and cataract surgery in 10 patients.
Our study outcomes show that Ozurdex treatment has a favorable long-term safety profile; and that it is effective for ME associated with RVO, although unlike the Geneva study, we highlight a markedly reduction of the efficacy after the 4th month. Reinjections on an “as-needed basis” stabilize the VA and macular thickness throughout the 2 years of follow-up.