European journal of pharmacology · 2026
Sustained ranibizumab port delivery for disease modification and treatment durability in diabetic retinopathy and diabetic macular edema: A systematic review and meta-analysis.
СтатьяСистематический обзорМетаанализНазвание и аннотация: Перевод в очереди
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Chen Kai-Yang, Chan Hoi-Chun, Chan Chi-Ming
Аннотация
INTRODUCTION: Diabetic retinopathy (DR) and diabetic macular edema (DME) are major causes of vision impairment. The ranibizumab port delivery system (PDS; Susvimo) enables sustained intraocular anti-vascular endothelial growth factor delivery and is designed to reduce treatment burden compared with frequent intravitreal injections.
METHODS: PubMed/MEDLINE, Scopus, the Cochrane Library, ScienceDirect, and Google Scholar were searched from inception to December 2, 2025, for studies evaluating ranibizumab PDS in DR and/or DME. Study selection followed modified population, intervention, comparator, outcomes, and study design (PICOS) criteria and distinguished therapeutic clinical evidence from device-engineering evidence. Risk of bias was assessed using the revised Cochrane risk-of-bias tool for randomized trials (RoB 2) and visualized with robvis for eligible randomized therapeutic trials. Random-effects proportion meta-analyses were performed as exploratory descriptive analyses when clinically appropriate datasets were available.
RESULTS: In center-involved DME, PDS every 24 weeks (Q24W) achieved noninferior best-corrected visual acuity (BCVA) gains compared with monthly ranibizumab through weeks 60 and 64 (+9.6 vs +9.4 Early Treatment Diabetic Retinopathy Study (ETDRS) letters; difference, 0.2 letters; 95% confidence interval (CI), -1.2 to 1.6). In nonproliferative diabetic retinopathy (NPDR) without center-involved DME, PDS every 36 weeks (Q36W) achieved at least 2-step Diabetic Retinopathy Severity Scale (DRSS) improvement in 80.1% of participants at week 52. Across the included therapeutic trial evidence, 39.0% to 80.1% of participants achieved at least 2-step DRSS improvement. In exploratory descriptive proportion meta-analyses, adverse events occurred in 22.3% of participants (95% CI, 18.8% to 26.4%), and supplemental treatment was required in 3.3% of participants (95% CI, 2.2% to 4.8%). No endophthalmitis was reported within the available DR/DME trial follow-up windows.
CONCLUSION: Ranibizumab PDS demonstrates sustained functional and DR-severity benefits and low supplemental-treatment requirements over the reported follow-up periods. Procedure- and implant-related adverse events should be interpreted with trial-specific denominators, event definitions, and follow-up windows, with longer-term and real-world safety data remaining necessary.
METHODS: PubMed/MEDLINE, Scopus, the Cochrane Library, ScienceDirect, and Google Scholar were searched from inception to December 2, 2025, for studies evaluating ranibizumab PDS in DR and/or DME. Study selection followed modified population, intervention, comparator, outcomes, and study design (PICOS) criteria and distinguished therapeutic clinical evidence from device-engineering evidence. Risk of bias was assessed using the revised Cochrane risk-of-bias tool for randomized trials (RoB 2) and visualized with robvis for eligible randomized therapeutic trials. Random-effects proportion meta-analyses were performed as exploratory descriptive analyses when clinically appropriate datasets were available.
RESULTS: In center-involved DME, PDS every 24 weeks (Q24W) achieved noninferior best-corrected visual acuity (BCVA) gains compared with monthly ranibizumab through weeks 60 and 64 (+9.6 vs +9.4 Early Treatment Diabetic Retinopathy Study (ETDRS) letters; difference, 0.2 letters; 95% confidence interval (CI), -1.2 to 1.6). In nonproliferative diabetic retinopathy (NPDR) without center-involved DME, PDS every 36 weeks (Q36W) achieved at least 2-step Diabetic Retinopathy Severity Scale (DRSS) improvement in 80.1% of participants at week 52. Across the included therapeutic trial evidence, 39.0% to 80.1% of participants achieved at least 2-step DRSS improvement. In exploratory descriptive proportion meta-analyses, adverse events occurred in 22.3% of participants (95% CI, 18.8% to 26.4%), and supplemental treatment was required in 3.3% of participants (95% CI, 2.2% to 4.8%). No endophthalmitis was reported within the available DR/DME trial follow-up windows.
CONCLUSION: Ranibizumab PDS demonstrates sustained functional and DR-severity benefits and low supplemental-treatment requirements over the reported follow-up periods. Procedure- and implant-related adverse events should be interpreted with trial-specific denominators, event definitions, and follow-up windows, with longer-term and real-world safety data remaining necessary.