Safety and efficacy of ranibizumab combined with dexamethasone intravitreal implant versus ranibizumab monotherapy for macular edema secondary to retinal vein occlusion: a 12-month prospective, randomized study.

Authors

Xiaohui Cai, Jianmin Wang, Jing Zhao, Yalong Dang

Published in

International ophthalmology. Volume 45. Issue 1. Pages 436. Oct 23, 2025. Epub Oct 23, 2025.

Abstract

To compare the 1-year efficacy and safety of intravitreal ranibizumab monotherapy against a combination therapy of ranibizumab and a dexamethasone intravitreal implant for treating macular edema secondary to retinal vein occlusion (RVO-ME). The primary research question assessed whether combination therapy resulted in superior improvements in best-corrected visual acuity (BCVA) and central macular thickness (CMT) compared to monotherapy.
This prospective, randomized, controlled study included 93 patients with RVO-ME. Patients were randomly assigned to either the ranibizumab monotherapy group (RBZ, n = 47) or the combination therapy group (RBZ + DEX, n = 46). The RBZ group received monthly ranibizumab for 3 months, while the RBZ + DEX group received ranibizumab at baseline, a dexamethasone implant 15 days later, and then ranibizumab for months 2 and 3. After the initial phase, both groups received pro-re-nata (PRN) retreatment based on specific criteria over a 12-month follow-up period.
At 52 weeks, both treatments significantly improved BCVA and CMT from baseline. The combination therapy group demonstrated significantly better BCVA improvement at weeks 4, 12, 26, and 52. The RBZ + DEX group also required significantly fewer injections and follow-up visits and had a longer mean retreatment interval. Ocular hypertension was more common in the combination group but was managed with medication. Subgroup analysis showed that the benefits of combination therapy on both visual and anatomical outcomes were more pronounced in patients with branch RVO (BRVO).
Combination therapy with ranibizumab and a dexamethasone implant provides superior visual outcomes and reduces the treatment burden compared to ranibizumab monotherapy for RVO-ME over 12 months. The safety profile was favorable, though monitoring for ocular hypertension is necessary. These benefits are particularly significant for patients with BRVO-ME.

PMID:
41128968
Bibliographic data and abstract were imported from PubMed on 23 Oct 2025.

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