Multimodal Imaging to Assess Disease Activity and Predict Fluid Resolution in Patients with wAMD Treated with Brolucizumab: The IMAGINE Study

Background: This prospective, open-label, single-arm, multicenter phase IV study (NCT04774926) evaluated early imaging parameters as predictors of long-term fluid resolution and assessed the efficacy and safety of brolucizumab in treatment-naïve patients with wet age-related macular degeneration (wAMD) in a real-world Italian setting. Patients and methods: A total of 122 patients aged ≥ 50 years with subfoveal macular neovascularization secondary to wAMD were enrolled. All patients were anti-vascular endothelial growth factor (anti-VEGF)- and investigational treatment-naïve. Brolucizumab (6 mg) was administered intravitreally at baseline and weeks 4 and 8, followed by maintenance dosing every 12 weeks (q12w) or 8 weeks, on the basis of disease activity. Imaging modalities included spectral-domain optical coherence tomography (OCT), OCT angiography, fluorescein angiography, and indocyanine green angiography. Disease activity was assessed using anatomical and functional parameters. Results: No significant predictive anatomical biomarkers for fluid-free status were identified. At week 48, 22.5% of patients achieved q12w fluid-free status. Significant reductions in central subfield thickness were observed, with a median change of −143.0 µm (p < 0.0001). Median best-corrected visual acuity improved by 5.5 Early Treatment Diabetic Retinopathy Study (ETDRS) letters from baseline (p < 0.0001). Ocular adverse events were consistent with the known safety profile of brolucizumab. Conclusions: Brolucizumab demonstrated effectiveness and safety in a real-world wAMD cohort, aligning with findings from randomized trials. Although no predictive biomarkers were identified, results emphasize the role of multimodal imaging in guiding individualized treatment strategies and highlight variability in patient responses. Clinicaltrials.gov ID: NCT04774926.