A Randomized-Controlled Trial of the Efficacy, Safety and Tolerability of Intravitreal Brolucizumab in Patients With Chronic Central Serous Chorioretinopathy With Persistent Fluid in the Absence of Choroidal Neovascular Membrane-BRICS Trial Report II.

Abstract

To study the efficacy of brolucizumab in chronic central serous chorioretinopathy (CSCR) with persistent fluid without choroidal neovascular membrane (CNVM). Prospective randomized-controlled trial with cross-over design. Patients with chronic CSCR (>3 months duration) without CNVM confirmed on optical coherence tomography angiography were enrolled and randomized (1:1) to treatment or control arms. Block randomization with stratification for disease duration and central macular thickness (CMT) was done. Patients in the treatment arm received intravitreal brolucizumab at baseline and then PRN. At 3 months follow-up, patients in the control arm with persistent fluid were crossed over to the injection arm. The primary outcome was a reduction of CMT on optical coherence tomography >20% compared to baseline. Secondary outcomes included proportion of eyes achieving complete fluid resolution at 1 and 3 months, mean change in CMT, subfoveal choroidal thickness (SFCT), best-corrected visual acuity, and NEI VFQ-25 scores. Of 42 patients (42 eyes), 3 were lost to follow-up. Final analysis included 22 patients in injection arm and 17 in control arm. Mean age was 52.3 ± 9.3 years; 92.3% were male. Greater than 20% CMT reduction at 1 month was noted in 17/22 (77.27%) in treatment arm and 6/16 eyes (37.5%) in the control arm (p = .01). At 1 month, 13/22 eyes (59%) achieved complete fluid resolution compared to 2/16 (12.5%) eyes in the control arm (p = .003). At 3 months follow-up, 12/20 eyes (60%) in the treatment arm achieved complete fluid resolution compared to 3/16 eyes (18.75%) in the control arm (p = .01). Mean CMT showed reduction in brolucizumab group compared to control at 1 month (158.16 ± 60 vs 318.22 ± 252.64 µm, p = .001) and 3 months (188.11 ± 78.83 vs 340.75.15 ± 264.52 µm, p = .016). Mean SFCT showed reduction in brolucizumab group compared to control at 1 month (419.53 ± 95.51 vs 472.40 ± 77.43 µm, p = .07) and 3 months (403.47 ± 127.36 vs 490.15 ± 105.50 µm, p = .05). 9 of 11 (81.82%) control eyes after crossover showed fluid resolution with brolucizumab. Change in best-corrected visual acuity and NEI VFQ-25 scores was not significant. Brolucizumab resulted in rapid resolution of fluid in chronic CSCR without CNVM, associated with significant reduction in CMT and SFCT. Long-term studies will help understand recurrence patterns and adverse effect profile.