A Study of 36-Week Refill Exchanges of Port Delivery System (PDS) With Ranibizumab in nAMD
NCT06847542 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 250
Last updated 2026-04-27
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
- DEVICE
-
Susvimo PDS Implant
Ranizumab will be administered via a PDS implant per the schedule described in the arm.
- DRUG
-
Participants will receive ranibizumab delivered through the PDS implant. Participants will receive ranibizumab, 0.5 mg IVT injections as a supplemental treatment.
Sponsors & Collaborators
-
Genentech, Inc.
collaborator INDUSTRY - lead INDUSTRY
Principal Investigators
-
Clinical Trials · Hoffmann-La Roche
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 50 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-11-27
- Primary Completion
- 2028-09-12
- Completion
- 2028-10-12
- FDA Drug
- Yes
- FDA Device
- Yes
Countries
- Austria
- Czechia
- Denmark
- France
- Germany
- Greece
- Italy
- Poland
- South Korea
- Spain
- Switzerland
- Thailand
- United Kingdom
Study Locations
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