Eye | 2021
Brolucizumab—early experience with early extended interval regime in chronic centre involved diabetic macular oedema
Brolucizumab (Beovu, Novartis, Basel, Switzerland) is the newest anti-vascular endothelial growth factor (anti-VEGF) drug. It was approved for the treatment of neovascular age-related macular degeneration (nAMD) on the basis of HAWK and HARRIER phase 3 trial results . Preliminary results of KITE and KESTREL trials have shown positive outcomes of brolucizumab in centre involved diabetic macular oedema (CiDMO) . Multiple studies related to brolucizumab use in nAMD have been published [3–5]. To the best of our knowledge, experience in cases of DMO has not been explored. Here we report the early clinical outcomes regarding safety and efficacy after off label brolucizumab administration in chronic non responding cases of DMO. A retrospective, consecutive, interventional, uncontrolled, single-centre study was conducted. Institutional Review Board approval was obtained, and the investigators adhered to the tenets of the Declaration of Helsinki. All patients were treated with intravitreal brolucizumab 6mg between November 2020 and May 2021. After receiving the first brolucizumab injection, the next injection was given when the visual acuity declined by one Snellen line or when the central foveal thickness (CFT) increased by 30%. Eyes with structural changes other than CiDMO and patients with vitreoretinal interface diseases were excluded. Each patient underwent best-corrected visual acuity (BCVA) measurement with a Snellen chart (converted to LogMAR for analysis), CST with spectral-domain optical coherence tomography (SD-OCT) and intraocular pressure (IOP) measurement along with complete ophthalmic examination at baseline and at the last follow-up after brolucizumab injection. Descriptive statistics including mean and standard deviation (SD) were calculated for continuous variables. A paired sample t-test was used to measure the mean differences between pre and post-injection values. All the statistical comparisons were made from the baseline visit. Thirteen eyes of 13 patients were included in this study. The patients received a total of 25 injections. All patients except one received 2 injections. The mean age was 52.9 ± 4.6 years and 61.5% were males. The mean follow-up period was 24.6 ± 4.05 weeks after the first injection of brolucizumab. All the eyes were previously treated with either single or a combination of other intravitreal anti-VEGFs and steroids (bevacizumab, ranibizumab, aflibercept, triamcinolone, dexamethasone implant). The mean number of previous injections (anti-VEGF and steroids) was 15.07 ± 4.3. Ten patients were on anti-glaucoma medications. Eight eyes had history of laser either pan retinal photocoagulation (PRP) or focal laser or both. Nine patients were diagnosed as moderate non proliferative diabetic retinopathy (NPDR) and 4 patients had stable proliferative diabetic retinopathy (PDR). Seven patients had controlled hypertension (HTN) along with diabetes mellitus (DM) and one patient had hypothyroidism along with HTN and DM. Subfoveal exudates were present in 4 eyes. Immediate data prior to the first brolucizumab injection was considered as the baseline, and the subsequent data after brolucizumab injection were included in the analysis.