Extension Study for the Port Delivery System With Ranibizumab (Portal)
NCT03683251 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1000
Last updated 2026-04-27
Summary
This study will evaluate the long-term safety and tolerability of the Port Delivery System with ranibizumab (PDS) (100 mg/mL) in participants with neovascular age-related macular degeneration (nAMD) who have either completed Phase II Study GX28228 (Ladder), Phase III Study GR40548 (Archway), Phase IIIb Study WR42221 (Velodrome), or completed Week 24 visit in Study WR42221 but were not eligible to be randomized in WR42221.
Conditions
- Neovascular Age-Related Macular Degeneration
Interventions
- DRUG
-
PDS Implant with Ranibizumab 100 mg/mL
Will be administered as per the schedule described in individual arm
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Clinical Trials · Hoffmann-La Roche
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 50 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2018-09-20
- Primary Completion
- 2029-10-31
- Completion
- 2029-10-31
- FDA Drug
- Yes
Countries
- United States
- Argentina
- Australia
- Austria
- Belgium
- Brazil
- France
- Germany
- Israel
- Italy
- Spain
- Switzerland
- Taiwan
- Turkey (Türkiye)
- United Kingdom
Study Locations
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