Safety and Efficacy of Two or More Dexamethasone Intravitreal Implants in Treatment-Naïve Patients with Macular Edema Due to Retinal Vein Occlusion

Abstract

Purpose: To evaluate the safety and efficacy of treatment with ≥2 dexamethasone intravitreal implants (DEX implants) in treatment-naïve patients with macular edema due to branch or central retinal vein occlusion (BRVO, CRVO).

Methods: A multicenter, retrospective, open-label chart review study (SHASTA study) evaluated the safety and efficacy of DEX implant in 289 patients with BRVO or CRVO who were treated with ≥2 DEX implants and followed for 3-6 months after the last implant. Adjunctive treatments for RVO were permitted. Efficacy outcome measures included best-corrected visual acuity (BCVA) and central retinal thickness (CRT) by optical coherence tomography. Subgroup analysis evaluated results in treatment-naïve patients who had received no treatment for complications of RVO prior to their first DEX implant.

Results: Thirty-nine patients were treatment-naïve at the time of their first DEX implant (18 BRVO, 21 CRVO). Prior to DEX implant treatment in treatment-naïve patients, mean duration of macular edema was 4.9 months, mean CRT was 550 µm, and mean BCVA was 8.5 lines (20/125 Snellen). Treatment-naïve patients received a mean of 2.9 DEX implants during the study period. DEX implant was used as monotherapy in 12 (30.8%) patients and combined with other RVO therapy in 27 (69.2%) patients. After the first through sixth DEX implant injections, mean change in BCVA from baseline ranged from +3.0 to +8.0 lines, and mean change in CRT from baseline ranged from -241 to -459 µm. BCVA improvement was seen both in BRVO and CRVO. Overall, 83.8% of patients gained at least 2 lines in BCVA, 70.3% gained at least 3 lines in BCVA, and 56.4% achieved CRT ≤250 µm during the study period. The most common adverse event was increased intraocular pressure. Fifteen treatment-naïve patients had an IOP measurement ≥25 mm Hg; no treatment-naïve patients required laser or incisional glaucoma surgery during the study period.

Conclusions: Use of ≥2 DEX implants either as monotherapy or in combination with other RVO treatments is safe and effective in reducing CRT and improving BCVA in treatment-naïve patients with BRVO or CRVO.

Keywords: 749 vascular occlusion/vascular occlusive disease • 487 corticosteroids • 748 vascular endothelial growth factor