NCT06847542

A Study of 36-Week Refill Exchanges of Port Delivery System (PDS) With Ranibizumab in nAMD

A Phase IIIb, Multicenter, Single-arm Study Assessing the Effectiveness, Safety and Patient Reported Outcomes of a 36-week Refill Exchange Regimen for the Port Delivery System With Ranibizumab in Patients With Neovascular Age-related Macular Degeneration

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 250 (estimated)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the effectiveness, safety, and PROs of the port delivery system with ranibizumab 100 milligrams/milliliters (mg/mL) refilled every 36 weeks (Q36W) in participants with nAMD.

Conditions

• Neovascular Age-related Macular Degeneration

Interventions

Type	Name	Description
DEVICE	Susvimo PDS Implant	Ranizumab will be administered via a PDS implant per the schedule described in the arm.
DRUG	Ranibizumab	Participants will receive ranibizumab delivered through the PDS implant. Participants will receive ranibizumab, 0.5 mg IVT injections as a supplemental treatment.

Timeline

• Start date: 2025-11-27
• Primary completion: 2028-09-12
• Completion: 2028-10-12
• First posted: 2025-02-26
• Last updated: 2026-03-30

Locations

53 sites across 13 countries: Austria, Czechia, Denmark, France, Germany, Greece, Italy, Poland, South Korea, Spain, Switzerland, Thailand, United Kingdom

Regulatory

• FDA-regulated drug study
• FDA-regulated device study