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Real-World Outcomes of the Ranibizumab Port Delivery System in Neovascular Age-Related Macular Degeneration and Diabetic Macular Edema: The SANTEE Study

Year: 2026
Type: preprint
Abstract: Purpose. To report real-world safety and treatment-procedure frequency with the ranibizumab port delivery system (PDS) in eyes with neovascular age-related macular degeneration (nAMD) or diabetic macular edema (DME), most of which managed with faricimab. Methods. Retrospective, consecutive, single-center case series of 81 eyes (64 patients) implanted October 2024 to March 2026, followed to 28 September 2026. All eyes contributed to safety (92.5 implant-years); the 79 eyes followed ≥ 3 months contributed to effectiveness, assessed principally through the second refill-exchange. Results. Of 79 effectiveness eyes, 61 had nAMD and 18 DME; 74 (93.7%) were on faricimab before implantation; the mean preimplant interval was 7.2 weeks. Over 92.5 implant-years there was no endophthalmitis, conjunctival erosion, implant dislocation, or explantation (upper 95% confidence limit 3.99 per 100 implant-years). Vitreous hemorrhage occurred in 4 eyes (3 with DME), 2 requiring vitrectomy. Four supplemental injections were given in 3 nAMD eyes. Median refill interval was 25 weeks; treatment procedures fell from 5.98 to 2.06 per nAMD eye and 5.72 to 2.00 per DME eye. Acuity was unchanged through the second refill-exchange and anatomic control was maintained. In an exploratory third-refill analysis of 22 nAMD eyes, acuity was 0.088 logMAR worse, substantially influenced by one eye. Conclusion. In a cohort predominantly managed with faricimab before implantation, PDS was associated with a 25-week median refill interval and an approximately two-thirds reduction in anti-VEGF treatment procedures, with acuity maintained through the second refill-exchange and no endophthalmitis over 92.5 implant-years.
DOI: 10.21203/rs.3.rs-11243327/v1
Language: English
Subfield: Ophthalmology
Field: Medicine
Open Access status: green
OpenAlex ID: W7225619386
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