Ranibizumab yields similar visual acuity gains with or without laser in BRVO patients
Use of laser in addition to ranibizumab in the treatment of patients with branch retinal vein occlusion (BRVO) does not result in better functional outcomes or lower treatment need, according to the results of the BRIGHTER study.
The phase IIIB, open-label trial randomly assigned 455 adult patients with visual impairment due to macular oedema secondary to BRVO to groups receiving ranibizumab 0.5 mg (n=183), ranibizumab 0.5 mg with laser (n=180) or laser (with optional ranibizumab 0.5 mg after month 6; n=92). Mean (and mean average) change in best-corrected visual acuity (BCVA) and central subfield thickness (CSFT) were the main outcome measures.
The trial consisted of two treatment periods, with the first period covering day 1 to month 6 and the second period covering months 6 to 23. After initial receipt of three monthly injections, patients on ranibizumab with or without laser received visual acuity (VA) stabilization criteria-driven pro re nata (PRN) treatment. On the other hand, patients assigned to the laser monotherapy arm were given ranibizumab from month 6 at the discretion of the investigators.
Of the patients, 380 (83.5 percent) completed the study. BCVA outcomes were superior in the two ranibizumab arms versus laser (monotherapy and combined with ranibizumab from month 6; 17.3 and 15.5 vs 11.6 letters; p<0.0001).
While the ranibizumab with laser arm was noninferior to ranibizumab monotherapy arm (mean average BCVA change, 15.4 vs 15.0 letters; p<0.0001), the addition of laser did not reduce the number of ranibizumab injections (mean injections, 11.4 vs 11.3; p=0.4259).
Ranibizumab with laser resulted in a greater reduction in CSFT over 24 months from baseline compared with ranibizumab monotherapy (ranibizumab monotherapy, −224.7 μm; ranibizumab with laser, −248.9 μm; laser [monotherapy and combined with ranibizumab from month 6], −197.5 μm).
Macular ischaemia did not influence BCVA outcome or treatment frequency. Neovascular glaucoma or iris neovascularization did not occur with any of the treatment arms, and no new safety signals were identified.
Despite the presence of limitations, the BRIGHTER study results confirm the long-term efficacy and safety profile of PRN dosing driven by individualized VA stabilization criteria using ranibizumab 0.5 mg in patients with BRVO, researchers said, adding that the safety results add to the well-established safety profile of the drug.