NCT05126966

A Study Of The Effectiveness And Safety Of A 36-Week Refill Regimen For The Port Delivery System With Ranibizumab Vs Aflibercept Treat & Extend In Subjects With Neovascular Age-Related Macular Degeneration

A Phase IIIb, Multicenter, Randomized, Visual Assessor-Masked Study Of The Effectiveness And Safety Of A 36-Week Refill Regimen For The Port Delivery System With Ranibizumab Vs Aflibercept Treat & Extend In Subjects With Neovascular Age-Related Macular Degeneration

• Status: Withdrawn
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

This study will evaluate the effectiveness and safety of a 36-week refill regimen for the Port Delivery System with ranibizumab 100 mg/mL (PDS Q36W) compared with intravitreal injections of aflibercept (2 mg) administered per treat-and-extend (aflibercept T\&E) in subjects with neovascular (wet) age-related macular degeneration (nAMD).

Conditions

• Neovascular Age-Related Macular Degeneration

Interventions

Type	Name	Description
DRUG	Ranibizumab	Ranibizumab will be administered at a dose of 100 mg/mL delivered via the PDS.
DRUG	Aflibercept	Aflibercept will be administered at a dose of 2 mg in the study eye per treat-and-extend. The decision to extend, maintain, or reduce the interval until next treatment will be per investigator judgment
DEVICE	Port Delivery System with ranibizumab (PDS)	PDS is an investigation intraocular drug delivery device designed to continuously deliver anti-VEGF therapy.

Timeline

• Start date: 2023-12-29
• Primary completion: 2025-01-31
• Completion: 2026-01-30
• First posted: 2021-11-19
• Last updated: 2024-01-18

Locations

10 sites across 7 countries: Argentina, Denmark, Greece, Hong Kong, Portugal, Spain, Thailand

Regulatory

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