12-Month Efficacy And Safety Evaluation Of Dexamethasone Intravitreal Implant In Patients With Macular Edema Due To Central Retinal Vein Occlusion

1. Young-Hee Yoon¹
2. Mark Gilles²
3. Anat Lowenstein³
4. Jenny Jiao⁴
5. Xiao-Yan Li⁴
6. Scott Whitcup⁴

¹Asan Medical Center, University of Ulsan, College of Medicine, Seoul, Korea
²University of Sydney, Sydney, Australia
³Tel Aviv Medical Center, Tel Aviv, Israel
⁴Allergan, Inc., Irvine, CA

Purpose: To evaluate the efficacy and safety of dexamethasone intravitreal implant (DEX implant, Ozurdex®) in patients with macular edema (ME) due to central retinal vein occlusion (CRVO).

Methods: Two identical, double-masked, sham-controlled, 6-month trials randomized patients with ME due to CRVO to receive DEX implant 0.7 mg (n=136) or sham procedure (n=147). At day 180, patients received open-label treatment with DEX implant 0.7 mg if best-corrected visual acuity (BCVA) was <84 letters or retinal thickness was >250μm. Respectively, 114 and 117 patients from the DEX implant 0.7-mg and sham groups received treatment during the open-label phase and were followed for an additional 6 months. Key outcomes were safety, BCVA, and central retinal thickness.

Results: At least 15 letters of BCVA were gained in 31% of patients at 60 days after the first DEX implant 0.7 mg (peak effect) and 27% gained ≥15 letters at 60 days after the second implant (day 240); 21% of patients from the sham group who received their first DEX implant 0.7 mg at day 180 gained ≥15 letters by day 240. Among patients who received a single, baseline DEX implant 0.7 mg (n=19), 53% completed the study, 42% gained ≥15 letters at day 180, and 26% at day 360. Increases in IOP were generally transient and similar following each DEX treatment.

Conclusions: In patients with ME due to CRVO, DEX implant 0.7 mg produced substantial improvements in BCVA and was well tolerated. The response to a second DEX implant after 6 months was similar.