NCT03683251

Extension Study for the Port Delivery System With Ranibizumab (Portal)

A Multicenter, Open-Label Extension Study to Evaluate the Long-Term Safety and Tolerability of the Port Delivery System With Ranibizumab in Patients With Neovascular Age-Related Macular Degeneration (Portal)

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,000 (estimated)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The Transscleral Photocoagulation sub-study (sub-study 1) will evaluate the effectiveness of using transscleral photocoagulation (TPC) with the Iridex laser system to mitigate vitreous hemorrhages secondary to the Port Delivery System with ranibizumab (PDS) implantation procedure in participants with neovascular age-related macular degeneration (nAMD). The sub-study will enroll about 55 participants. The Re-implantation sub-study (sub-study 2) will evaluate the safety of re-implantation with the updated PDS with ranibizumab . Up to 100 participants who previously participated in the main study in the United States will be enrolled and followed for a maximum of 72 weeks post-re-implantation in the substudy.

Conditions

• Neovascular Age-Related Macular Degeneration

Interventions

Type	Name	Description
DRUG	PDS Implant with Ranibizumab 100 mg/mL	Will be administered as per the schedule described in individual arm

Timeline

• Start date: 2018-09-20
• Primary completion: 2029-10-31
• Completion: 2029-10-31
• First posted: 2018-09-25
• Last updated: 2026-03-30

Locations

165 sites across 15 countries: United States, Argentina, Australia, Austria, Belgium, Brazil, France, Germany, Israel, Italy, Spain, Switzerland, Taiwan, Turkey (Türkiye), United Kingdom

Regulatory

• FDA-regulated drug study