A post‐market surveillance study on the processing and follow‐up of patients with BRVO and CRVO prescribed Ozurdex

Abstract

AbstractPurpose Examine the use in clinical practice of a dexamethasone intravitreal implant (Ozurdex®, Allergan, Inc., CA) in treating macular oedema (ME).Methods Prospective observational study (20 centres in Sweden, Denmark, Norway and Finland). Patients were enrolled if prescribed Ozurdex® 700 μg for ME after branch or central retinal vein occlusion (BRVO/CRVO). Baseline examinations included visual acuity (VA), central retinal thickness (CRT) and intraocular pressure (IOP). Efficacy measures were time to retreatment, VA (ETDRS) and CRT (OCT) at weeks 6, 12, 24, 36 and 48. Adverse events (AEs) and discontinuations were recorded.Results 99 patients (51% CRVO, 49% BRVO) were enrolled, mean age 72.9 years. Median follow‐up was 403 days (36–609 days), with 45.5%, 24.2% and 24.2% of participants receiving 1, 2, and 3 injections, respectively (<10% received ≥4). Among retreated patients, 25.3% received the first retreatment at week 24. Mean time to first retreatment was 185 days. Median VA and CRT were similar between BRVO and CRVO groups throughout the study. At baseline, median VA was 54.9 letters, median CRT 499 μm and median IOP 15 mmHg. At week 12, VA increased to 67.5 letters and CRT decreased to 297 μm. At week 36, these were 60.2 letters for VA and 318 μm for CRT. Increased IOP (26.3%) and cataracts (4.1%) were the only AEs recorded in >1% of patients; endophthalmitis, eye complication, eye pain and vitreous haemorrhage were each reported once.Conclusion In this non‐interventional, open‐label study of routine clinical practice, the major short‐term outcomes of improved mean VA and reduced mean CRT were comparable to those in clinical trials. Implementation of Ozurdex® was not associated with new or unexpected events. Commercial interest