Sustained ranibizumab port delivery for disease modification and treatment durability in diabetic retinopathy and...

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.

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.

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.

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.