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

No results posted yet for this study

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

Ranibizumab

Participants will receive ranibizumab delivered through the PDS implant. Participants will receive ranibizumab, 0.5 mg IVT injections as a supplemental treatment.

Sponsors & Collaborators

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

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06847542 on ClinicalTrials.gov