MedTrace Logo

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

NCT05126966 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2024-01-18

No results posted yet for this study

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

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.

Sponsors & Collaborators

Principal Investigators

  • Clinical Trials · Hoffmann-La Roche

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-29
Primary Completion
2025-01-31
Completion
2026-01-30
FDA Drug
Yes
FDA Device
Yes

Countries

  • Argentina
  • Denmark
  • Greece
  • Hong Kong
  • Portugal
  • Spain
  • Thailand

Study Locations

More Related Trials

Entities

Drugs
Companies

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 NCT05126966 on ClinicalTrials.gov