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    Port Delivery System (PDS) with Ranibizumab (100 mg/ml)

    Other names: RG6321; RO4893594

    Modality: Recombinant humanized monoclonal antibody fragment

    Disease State: Neovascular Age-related Macular Degeneration (nAMD), Diabetic Macular Edema (DME), and Diabetic Retinopathy (DR)

    Summary

    Port Delivery System (PDS) with ranibizumab (100 mg/ml) is a permanent refillable eye implant which is designed to continuously release a customized formulation of ranibizumab into the eye over time. Ranibizumab is a Vascular Endothelial Growth Factor (VEGF) inhibitor designed to bind to and inhibit VEGF-A, a protein that is believed to play a critical role in the formation of new blood vessels (angiogenesis) and the hyperpermeability (leakiness) of the vessels.1,2

    Clinical Trials

    Ranibizumab
    NCT ID Study Phase Enrollment Status Study Title
    NCT04853251 Phase IV Recruiting A Study Assessing Corneal Endothelial Cells in Participants With Neovascular Age-related Macular Degeneration (nAMD) Treated With the Port Delivery System With Ranibizumab (PDS) View details
    NCT03683251 Phase III Recruiting Extension Study for the Port Delivery System With Ranibizumab (Portal) View details
    NCT04108156 Phase III Active, not recruiting A Study to Evaluate Efficacy, Safety & Pharmacokinetics of the Port Delivery System (PDS) With Ranibizumab in Participants With Diabetic Macular Edema (DME) Compared With Intravitreal Ranibizumab; A Substudy to Evaluate the Safety of Re-implanting the PDS With Ranibizumab in Participants With DME View details
    NCT04657289 Phase III Active, not recruiting A Study of the Efficacy, Safety, and Pharmacokinetics of a 36-Week Refill Regimen for the Port Delivery System With Ranibizumab in Patients With Neovascular Age-Related Macular Degeneration (Velodrome) View details
    NCT06847542 Phase III Recruiting A Study of 36-Week Refill Exchanges of Port Delivery System (PDS) With Ranibizumab in nAMD View details
    1. Roche. Product Development Portfolio. Published January 30, 2025. Accessed February 12, 2025. https://www.roche.com/​solutions/​pipeline
    2. FDA Approves Genentech’s Suvismo as the First and Only Continuous Delivery Treatment for the Leading Cause of Diabetes-Related Blindness. Genentech. Published February 4, 2025. Accessed June 29, 2026. https://www.gene.com/​media/​press-releases/​15050/​2025-02-04/​fda-approves-genentechs-susvimo-as-the-f

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    TOP

    • DME
      diabetic macular edema

    • nAMD
      neovascular age-related macular degeneration

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