Jueling Mingmu decoction combined with ranibizumab for retinal vein occlusion induced macular edema: A randomized controlled clinical trial.

Abstract

Background/aims: To investigate the efficacy of a combined treatment approach using Jueling Mingmu Decoction and ranibizumab in managing macular edema (ME) associated with retinal vein occlusion (RVO).

Methods: This prospective, randomized, controlled, outcome assessor-blinded superiority trial involved 111 patients with treatment-naïve RVO and ME, including 53 patients assigned to the ranibizumab monotherapy group and 58 to the combination therapy group. Participants were randomly assigned to receive either intravitreal injections of 0.5 mg ranibizumab alone (monotherapy group) or combined with daily consumption of Jueling Mingmu Decoction (combination group). Primary outcomes included the number of intravitreal injections administered over 48 weeks. Secondary outcomes included changes in best-corrected visual acuity (BCVA) and central subfield fovea thickness (CST).

Results: 99 patients (89.2%) completed the 48-week follow-up, including 46 of 53 patients (86.8%) in the monotherapy group and 53 of 58 patients (91.4%) in the combination group. The monotherapy group received an average of 4.35 ± 1.73 injections, while the combination group received 4.64 ± 1.92 injections (P = 0.471), with no significant difference between the groups. BCVA improved significantly in both groups, with the combination group showing a greater improvement at 48 weeks in patients with branch RVO (BRVO) compared to the monotherapy group (P = 0.031). CST decreased significantly in both groups, with the combination group showing a significantly lower CST at 36 weeks in BRVO patients (P = 0.018). No significant differences were observed between the groups for central retinal vein occlusion (CRVO) patients.

Conclusion: The combination of Jueling Mingmu Decoction and ranibizumab appears to be a potentially effective treatment for improving visual and anatomical outcomes in RVO-related ME, especially in BRVO patients. However, it does not significantly reduce the number of required intravitreal injections compared to monotherapy. Further studies are needed to confirm these findings and explore the long-term efficacy and safety of this treatment approach.