SAFETY AND FEASIBILITY OF A NOVEL 25-GAUGE BIODEGRADABLE IMPLANT OF DEXAMETHASONE FOR TREATMENT OF MACULAR EDEMA ASSOCIATED WITH RETINAL VEIN OCCLUSION: A PHASE I CLINICAL TRIAL.

PURPOSE: To evaluate the safety and feasibility of a 25-gauge biodegradable implant containing 350 µg of dexamethasone (DDS-25) for the treatment of decreased vision due to macular edema associated with central or branch retinal vein occlusion. METHODS: Prospective, nonrandomized, open-label, Phase I clinical trial, including 10 patients with decreased vision (best-corrected early treatment diabetic retinopathy study visual acuity of 20/40 or worse) due to macular edema associated with central retinal vein occlusion (n = 4) or branch retinal vein occlusion (n = 6) for more than 4 months. Comprehensive ophthalmic evaluation, including best-corrected visual acuity, spectral domain optical coherence tomography (Spectralis Heidelberg Engineering) for determination of central subfield thickness, full-field electroretinography (ISCEV standard ERG), and fluorescein angiography, was performed at baseline, and 1, 4, 12, and 24 weeks after intravitreal DDS-25 insertion. RESULTS: Mean best-corrected visual acuity was 0.72 ± 0.1 logMAR (20/100) at baseline and improved by 7 early treatment diabetic retinopathy study letters to 0.58 ± 0.08 logMAR (20/80 + 1) at 24 weeks (P = 0.049), with 3 central retinal vein occlusion and 3 branch retinal vein occlusion patients improving between 1 and 4 early treatment diabetic retinopathy study lines. Significant central subfield thickness reduction was observed at 24 weeks compared with baseline (P = 0.011); mean ± standard error (range) central subfield thickness (µm) was 461.2 ± 41.3 (288-701) at baseline, and 439.6 ± 40.4 (259-631), 442.5 ± 44.6 (255-632), 354.6 ± 31.2 (228-537), and 316.5 ± 26.4 (226-441) at 1, 4, 12, and 24 weeks, respectively. No significant changes in electroretinography responses or area of retinal nonperfusion were observed during 24 weeks of follow-up. There was no significant change in mean intraocular pressure at any of the study visits compared with baseline. One patient had mild anterior chamber inflammation (1-5 cells) at one week after DDS-25 insertion. CONCLUSION: In this Phase I study demonstrating the feasibility of intravitreal DDS-25 insertion for the treatment of decreased vision due to macular edema associated with retinal vein occlusion, no safety concerns were observed. A larger prospective randomized study with longer follow-up is warranted to confirm these findings.