A Randomized, Placebo-controlled Study of the Efficacy, Safety and Tolerability of Intravitreal Brolucizumab in patients with Chronic Central Serous Retinopathy with persistent fluid in the absence of choroidal neovascular membrane – interim analysis

Abstract

Purpose : There is no consensus on the management of chronic Central Serous Chorioretinopathy (CSCR) without choroidal neovascular membrane (CNVM). We aim to evaluate the role of intravitreal brolucizumab in achieving rapid resolution of persistent fluid in chronic CSCR.

Methods : This study is a prospective, randomized controlled trial (CTRI/2023/06/053778) comparing intravitreal brolucizumab with placebo for treatment of persistent macular fluid in chronic CSCR (>3 months). Block randomization with stratification for duration of fluid, and central macular thickness was done. Absence of CNVM was confirmed using optical coherence tomography (OCT) angiography, fundus fluorescein angiography and indocyanine green angiography. Patients in the control group received oral multivitamins daily, patients in the study arm received intravitreal brolucizumab (6mg/0.05ml). Primary outcome measure was fluid resolution on OCT.

Results : We present the interim results of 12 eyes (12 patients). 5 eyes were randomized to control arm and 7 eyes to the injection arm. 11 patients (91.67%) were male. Median duration of disease was 44.5 months. The median best corrected visual acuity (BCVA) at presentation was 0.37 logMAR. 5/7 eyes achieved complete resolution of intraretinal and subretinal fluid at 1 month in the injection arm, while none of the eyes in control group showed resolution of fluid on OCT (p=0.0133). Two eyes which did not show complete resolution of fluid, were advised repeat injection. Mean central macular thickness (CMT) in the injection arm at presentation was 261±92.8 mm and at 1 month post injection was 189.4±51.7 mm (p=0.014). Mean subfoveal choroidal thickness (SFCT) in the injection arm at presentation was 338±92.9 mm and at 1 month post injection was 282.8±56.3 mm (p=0.04). The difference in mean CMT and SFCT in the control group was not statistically significant. The difference in logMAR BCVA at baseline and 1 month follow up was not significant in both groups. None of the eyes that received intravitreal brolucizumab developed intraocular inflammation in this study.

Conclusions : Intravitreal brolucizumab is a promising solution for rapid resolution of fluid in chronic CSCR. Long term follow up for recurrence and safety of injections is required.

This abstract was presented at the 2024 ARVO Annual Meeting, held in Seattle, WA, May 5-9, 2024.