Clinical ophthalmology (Auckland, N.Z.) · 2025
Quantitative Assessment of En‑face OCT‑Derived Minimum Intensity Fluid Changes Following Ranibizumab Biosimilar Therapy in Macular Neovascularization Secondary to nAMD and PCV.
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Sheth Jay Umed, Bhopalka Ankit Kumar, Meshram Bhagyashree, Karande Sayali
Аннотация
PURPOSE: This retrospective study aimed to evaluate the efficacy of a new regulatory approved ranibizumab biosimilar (RzB), Oceva® (Sun Pharmaceutical Industries Limited, Mumbai, India), in treating macular neovascularization secondary to neovascular age-related macular degeneration (nAMD) and polypoidal choroidal vasculopathy (PCV), using Minimum-Intensity based changes observed on en-face optical coherence tomography (OCT) (en-face MI OCT).
PATIENTS AND METHODS: Thirty-six eyes with treatment-naïve MNV underwent three loading doses of RzB. Best-corrected visual acuity (BCVA) and the proportions of eyes with subretinal fluid (SRF), intraretinal fluid (IRF), and subretinal hyperreflective material (SHRM) were assessed. En-face MI OCT-based analysis was conducted to quantify changes in fluid area and perimeter.
RESULTS: At 12 weeks, there was a statistically significant improvement in BCVA from 0.94 {≈20/174} (± 0.59) logMAR to 0.84 {≈20/138} (± 0.61) logMAR (P=0.04). En-face MI OCT revealed a significant reduction in the median area of fluid from 0.9 mm² (IQR 0.62-4.56) to 0.32 mm² (IQR 0.1-0.64) (P=0.007), and in the median perimeter of fluid from 10.95 mm (IQR 7.26-25.67) to 6.02 mm (IQR 1.76-7.93) (P=0.0005). The proportion of eyes with SRF, IRF, and SHRM decreased from baseline (83.33%, 66.67%, and 58.33% respectively) to 12 weeks (58.33% [P=0.015], 38.89% [P=0.013], and 13.89% [P<0.001]). No adverse events were reported.
CONCLUSION: Treatment with the novel RzB showed promising outcomes in improving visual parameters and reducing fluid accumulation in patients with MNV secondary to nAMD and PCV. Minimum Intensity-based analysis provided detailed insights into fluid dynamics, demonstrating its utility in evaluating treatment responses in MNV. This study contributes to the initial assessment of RzB in clinical practice, highlighting its potential efficacy in managing MNV.
PATIENTS AND METHODS: Thirty-six eyes with treatment-naïve MNV underwent three loading doses of RzB. Best-corrected visual acuity (BCVA) and the proportions of eyes with subretinal fluid (SRF), intraretinal fluid (IRF), and subretinal hyperreflective material (SHRM) were assessed. En-face MI OCT-based analysis was conducted to quantify changes in fluid area and perimeter.
RESULTS: At 12 weeks, there was a statistically significant improvement in BCVA from 0.94 {≈20/174} (± 0.59) logMAR to 0.84 {≈20/138} (± 0.61) logMAR (P=0.04). En-face MI OCT revealed a significant reduction in the median area of fluid from 0.9 mm² (IQR 0.62-4.56) to 0.32 mm² (IQR 0.1-0.64) (P=0.007), and in the median perimeter of fluid from 10.95 mm (IQR 7.26-25.67) to 6.02 mm (IQR 1.76-7.93) (P=0.0005). The proportion of eyes with SRF, IRF, and SHRM decreased from baseline (83.33%, 66.67%, and 58.33% respectively) to 12 weeks (58.33% [P=0.015], 38.89% [P=0.013], and 13.89% [P<0.001]). No adverse events were reported.
CONCLUSION: Treatment with the novel RzB showed promising outcomes in improving visual parameters and reducing fluid accumulation in patients with MNV secondary to nAMD and PCV. Minimum Intensity-based analysis provided detailed insights into fluid dynamics, demonstrating its utility in evaluating treatment responses in MNV. This study contributes to the initial assessment of RzB in clinical practice, highlighting its potential efficacy in managing MNV.