A Phase IIIb, Multicenter, Single-arm Study Assessing the Effectiveness, Safety and Patient Reported Outcomes of a 36-week Refill Exchange Regimen for the Port Delivery System With Ranibizumab in Patients With Neovascular Age-related Macular Degeneration
Status: Recruiting
Location: See all (13) locations...
Intervention Type: Drug, Device
Study Type: Interventional
Study Phase: Phase 3
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 50
Healthy Volunteers: f
View:
• Initial diagnosis of nAMD within 24 months prior to screening
• Previous treatment with at least 3 anti-vascular endothelial growth factor (VEGF) IVT injections for nAMD per standard of care within 6 months prior to screening
• Demonstrated response to prior anti-VEGF IVT treatment since diagnosis
• Availability of historical VA data obtained at or after nAMD diagnosis and prior to the first anti-VEGF treatment for nAMD
• Availability of historical OCT image data obtained at or after nAMD diagnosis and prior to the first anti-VEGF treatment for nAMD
• BCVA of 34 letters or better using ETDRS chart at a starting distance of 4 meters at screening and enrollment visits
Locations
Other Locations
Austria
Kepler Universitätskliniken GmbH - Med Campus III
RECRUITING
Linz
Landesklinikum Mistelbach
RECRUITING
Mistelbach
France
Institut Ophtalmologique De l Ouest Jules Verne
RECRUITING
Nantes
Germany
Medizinische Hochschule Hannover, Klinik für Augenheilkunde
RECRUITING
Hanover
Greece
University Hospital of Larissa
RECRUITING
Larissa
Poland
OFTALMIKA Sp. z o.o
RECRUITING
Bydgoszcz
MW-med
RECRUITING
Krakow
Centrum Diagnostyki i Mikrochirurgii Oka LENS
RECRUITING
Olsztyn
Republic of Korea
Kyungpook National University Hospital
RECRUITING
Daegu
Ajou University Medical Center
RECRUITING
Gyeonggi-do
Hallym University Kangnam Sacred Heart Hospital
RECRUITING
Seoul
Seoul St Mary's Hospital
RECRUITING
Seoul
Severance Hospital, Yonsei University Health System
RECRUITING
Seoul
Contact Information
Primary
Reference Study ID Number: MR45625 https://forpatients.roche.com/
global-roche-genentech-trials@gene.com
888-662-6728 (U.S.)
Time Frame
Start Date:2025-11-27
Estimated Completion Date:2028-10-12
Participants
Target number of participants:250
Treatments
Experimental: Port Delivery System (PDS)
Participants will have the PDS implant (pre-filled with 100 mg/mL of ranibizumab) \[approximately 2-milligrams (mg) dose\] surgically inserted in the study eye on Day 1. Participants who meet the disease activity criteria (DAC) at Week 24 or receive supplemental treatment with intravitreal (IVT) injections of ranibizumab prior to Week 24 will receive implant refill exchanges every 24 weeks (Q24W). Participants who do not meet the DAC at Week 24 and have not received supplemental treatment will receive PDS refill exchanges Q36W.