Ranibizumab ±adjunctive laser vs laser in patients with visual impairment due to macular edema secondary to branch retinal vein occlusion (BRVO): Design and baseline characteristics of the BRIGHTER study

Abstract

Purpose: The BRIGHTER study was designed to compare an individualized, stabilization-criteria driven pro re nata (PRN) dosing regimen of ranibizumab (RBZ) 0.5mg (±adjunctive laser) vs laser photocoagulation up to Month (M) 6 and then to evaluate its long-term (24M) efficacy and safety in patients with visual impairment due to macular edema (ME) secondary to BRVO. Here, we describe the study design and baseline characteristics of enrolled patients.

Methods: In this ongoing 24M, phase IIIb, open-label, active-controlled, three-arm, multicenter study, patients were randomized 2:2:1 to RBZ alone (G1), RBZ+laser (G2) or laser alone (G3) groups. Patients in G1 and G2 received monthly RBZ 0.5mg until visual acuity (VA) stabilization and PRN thereafter. Laser was applied to patients with perfused ME in G2 and G3 (PRN based on physicians assessment). After M6, G3 patients can receive RBZ. All patients are monitored monthly up to M12 and can be every 2M thereafter, dependent on stable VA and absence of disease activity. Key objectives: superiority of RZB 0.5mg±laser vs laser at M6 (primary endpoint); non-inferiority of RBZ+laser vs RBZ alone (to M24) and, if successful, evaluate the impact of laser in reducing the number of RBZ retreatments up to M23.

Results: 455 patients (mean age 66.3 years, 50.3% female) were enrolled from 81 sites in Europe, Australia and Canada. Baseline ocular characteristics are as follows—mean baseline BCVA: 57.6 (±12.9, SD) letters; mean intraocular pressure (IOP): 15.3 (±2.8, SD) mmHg; prior duration of BRVO (median): 3M and 25.1% patients had retinal ischemia (according to the judgment of investigator).The most frequent medical history findings were hypertension (n=274), hypercholesterolemia (n=101), cataract/cataract operation (n=95) and hyperlipidemia (n=47).

Conclusions: The study population was comparable to the pivotal BRAVO study in terms of age, gender, and mean baseline IOP and prior duration of BRVO. Differences to BRAVO included higher mean baseline BCVA (58 vs 53 letters) and possibly a higher proportion of ischemic patients (25% vs. 0%), although this was assessed by the investigators and not by the Central Reading Center. The patients enrolled in the BRIGHTER study are well suited to investigate the long-term safety and efficacy of RBZ (±adjunctive laser) in BRVO.

Keywords: 585 macula/fovea • 505 edema • 748 vascular endothelial growth factor