Clinical evaluation of faricimab in real-world neovascular age-related macular degeneration in India: a multicenter observational study
摘要
To evaluate the 12-month effectiveness and treatment burden of intravitreal faricimab in treatment-naive neovascular age-related macular degeneration (nAMD) in real-world clinical practice across multiple Indian centers.
MethodsThis retrospective multicenter observational study included 45 eyes with treatment-naive nAMD treated with intravitreal faricimab (6.0 mg) using four monthly loading injections followed by pro re nata (PRN) retreatment. Best-corrected visual acuity (BCVA, logMAR) and central subfield thickness (CST) were recorded at baseline and at 1, 2, 3, 4, 6, 9, and 12 months. The presence of subretinal fluid (SRF), intraretinal fluid (IRF), and sub-retinal pigment epithelium (sub-RPE) fluid was documented. Fluorescein angiography (FA) was performed in 36 eyes and enabled angiographic lesion characterization in these eyes; indocyanine green angiography was performed selectively when clinically indicated. Injection burden and safety outcomes were also assessed.
ResultsMean BCVA improved from 0.52 ± 0.18 logMAR at baseline to 0.08 ± 0.07 at month 12 (mean change, -0.44 ± 0.19; P < 0.0001). Mean CST decreased from 418.38 ± 49.87 μm to 201.53 ± 10.47 μm (mean change, -216.85 ± 50.65 μm; P < 0.0001). The proportions of eyes with SRF, IRF, and sub-RPE fluid declined from 82.2%, 86.7%, and 60.0% at baseline to 13.3%, 4.4%, and 0%, respectively, at month 12 (all P < 0.0001). Complete OCT drying was achieved in 39/45 eyes (86.7%). The mean total injection count was 5.09 ± 0.42, including 1.09 ± 0.42 maintenance injections after loading. No hemorrhagic recurrence or serious ocular or systemic adverse events were observed.
ConclusionsIn this real-world Indian cohort, faricimab was associated with favorable visual and anatomical outcomes over 12 months, with a low maintenance injection burden. These findings should be interpreted cautiously because of the retrospective design and absence of a comparator arm.