SynthesisGraefe's archive for clinical and experimental ophthalmology = Albrecht von Graefes Archiv fur klinische und experimentelle Ophthalmologie2025
Ranibizumab biosimilars vs. reference Ranibizumab for neovascular age-related macular degeneration: a systematic review and meta-analysis.
Synthesis in Graefe's archive for clinical and experimental ophthalmology = Albrecht von Graefes Archiv fur klinische und experimentelle Ophthalmologie, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
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Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Authors and funding
8 authors.
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No grant is acknowledged in the PubMed record.
Abstract
purposeNeovascular age-related macular degeneration (nAMD) is a leading cause of vision loss, with anti-vascular endothelial growth factor therapy being effective but costly. This systematic review and meta-analysis assessed the efficacy, safety, and immunogenicity of ranibizumab biosimilars versus ranibizumab in nAMD.
methodsWe systematically searched PubMed, Embase, Cochrane Library, and ClinicalTrials.gov for randomized controlled trials (RCTs) comparing ranibizumab biosimilars with reference ranibizumab in nAMD. Outcomes included: (1) best-corrected visual acuity (BCVA), (2) proportion of patients losing fewer than 15 BCVA letters, (3) central subfield thickness (CST), (4) choroidal neovascularization (CNV) size, (5) safety outcomes, and (6) anti-drug antibodies (ADA). Data were pooled using a random-effects model, and heterogeneity assessed by I².
resultsTen RCTs (3704 eyes) were included, with 1944 (52.5%) receiving biosimilars. At short-term follow-up (8-16 weeks), biosimilars significantly improved BCVA over reference (MD -0.81 letters; 95% CI -1.41 to -0.21; p = 0.008), although this difference is clinically negligible. At long-term follow-up (48-52 weeks), there was a non-significant trend toward greater BCVA improvement (MD -0.75 letters; 95% CI -1.62 to 0.12; p = 0.09). The proportion losing fewer than 15 BCVA did not differ significantly (RR 0.99; 95% CI 0.98 to 1.00; p = 0.21). CST changes were comparable. Notably, biosimilars reduced CNV size at long-term follow-up (MD -0.39 mm²; 95% CI -0.68 to -0.09; p = 0.01). Safety outcomes and ADA incidence were similar between groups.
conclusionsRanibizumab biosimilars demonstrate comparable safety, immunogenicity, and efficacy to reference ranibizumab. The small short-term BCVA difference is not clinically meaningful, supporting biosimilars as cost-effective alternatives for nAMD.
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41075000What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.