Dexamethasone Intravitreal Implant for Previously Untreated Macular Edema due to Retinal Vein Occlusion: An Open-label Phase IV Study in China

Effective treatment of retinal vein occlusion (RVO) is critical to improve vision outcomes. The requirement for repeated intravitreal injection of available therapies highlights the need for treatments with reduced dosing frequency. This open-label, post-approval YANGTZE study (NCT03908307) evaluated dexamethasone implants in Chinese patients with macular edema due to RVO.

Eligible patients had previously untreated macular edema due to RVO. Patients received dexamethasone implants of 700 μg at study entry and were followed up for 12 months; additional injections were administered based on clinical judgement. Primary endpoints were mean change from baseline (CFB) in best-corrected visual acuity (BCVA), the proportion of patients with improvement in BCVA of 15 letters or more at month 6, and area under the curve (AUC) analysis of average CFB in BCVA.

In total, 70 patients were enrolled and treated with dexamethasone implants (mean 2.3 injections). The mean ± standard deviation CFB in BCVA was 10.3 ± 12.1 letters at month 6 and 10.5 ± 12.1 letters at month 12 (both p < 0.001 vs. baseline). Improvement from baseline in BCVA of 15 letters or more was reported in 34.3% and 37.1% of patients at months 6 and 12, respectively. AUC analysis of CFB in BCVA showed significant improvement throughout the study (p < 0.001). The most frequent adverse event was increased intraocular pressure, which was reported in 26 patients (37.1%).

Chinese patients with RVO treated with dexamethasone intravitreal implant in real-world clinical practice demonstrated sustained improvement in BCVA over 1 year. Safety outcomes were found to be consistent with those reported in previous studies.