Patients with macular edema due to retinal vein occlusion treated with 0.5mg ranibizumab have no added benefit from increased ranibizumab dose or laser photocoagulation; the RELATE Study

Abstract

Purpose: To compare monthly dosing for 6 months with 0.5mg vs 2mg ranibizumab (RBZ) and determine if laser photocoagulation (Laser) provides benefit in patients with macular edema (ME) due to retinal vein occlusion (RVO).

Methods: Eighty one patients with ME due to RVO, 39 with central RVO (CRVO) and 42 with branch RVO (BRVO) received 0.5mg or 2mg RBZ every 4 weeks; primary outcome was mean change from baseline (BL) best-corrected visual acuity (BCVA) in ETDRS letter score at 24 weeks. At week 24 patients were re-randomized to Laser+RBZ prn or only RBZ prn. Mean change from week 24 BCVA, central subfield thickness (CST) and number of RBZ injections were compared between Laser+RBZ vs RBZ alone at weeks 48 and 96.

Results: Mean BL BCVA letter score for 0.5mg vs 2.0mg group was 46.8±3.8 vs 45.3±3.6 in CRVO and 54.3±3.2 vs 48.9±3.6 in BRVO groups. For 0.5mg vs 2mg groups, the mean gain from BL BCVA letter score at week 24 was 16.6±2.2 vs 17.2±2.8 in CRVO and 12.1±2.9 vs 14.6±2.3 in BRVO groups. For CRVO, there was significantly greater reduction from BL mean CST in the 2.0mg vs 0.5mg group (393.1±48.1 vs 253.5±43µm, p=0.04) but no difference for the BRVO groups (292.1±51.7 vs 203.3±41.0µm, p=0.26). For CRVO, there was no difference from week 24 BCVA in Laser+RBZ vs RBZ alone at 48 (-3.3±2.7 vs -1.0±2.1) and week 96 (+0.3±2.8 vs -2.4±2.7) while there was a significant increase from week 24 mean CST at week 48 (+94.7±27.4 vs +17.6±36.9µm, p= 0.05), but not at week 96 (+19.8±16.0 vs +28.3±43.8µm). In BRVO, there was significant reduction from week 24 BCVA in Laser+RBZ vs RBZ alone at week 48 (-7.5±1.7 vs +2.5±2; p<0.01) and week 96 (-2.2±1.7 vs +4.9±2.6, p <0.01). There was no difference from week 24 mean CST at week 48 (+70.1±27.9 vs -27.3±38.7µm) or week 96 (+21.1±26.3 vs -39.4±41.4µm). Significantly more RBZ injections were required between week 24 and 96 in the Laser+RBZ vs RBZ alone group for patients with CRVO (11.1±1.2 vs 7.8 ±1.0, p=0.04) but not those with BRVO (10.4 ±1.2 vs 10.2±1.1).

Conclusions: In patients with macular edema due to RVO there is no clinically significant benefit at 24 weeks from monthly injections of 2mg vs 0.5mg RBZ and no long term benefit in BCVA, resolution of edema or number of RBZ injections obtained from addition of Laser to RBZ injections.