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 (51) 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
Medizinische Universität Innsbruck
RECRUITING
Innsbruck
Kepler Universitätskliniken GmbH - Med Campus III
RECRUITING
Linz
Landesklinikum Mistelbach
RECRUITING
Mistelbach
Denmark
Aarhus Universitetshospital
RECRUITING
Aarhus N
Rigshospitalet Glostrup
RECRUITING
Glostrup Municipality
France
Hopital Edouard Herriot - CHU Lyon
RECRUITING
Lyon
Clinique Honore Cave
RECRUITING
Montauban
Institut Ophtalmologique De l Ouest Jules Verne
RECRUITING
Nantes
CHNO des Quinze Vingts
RECRUITING
Paris
CHU Poitiers - CHR La Miletrie
RECRUITING
Poitiers
CHU Strasbourg - Nouvel Hopital Civil
RECRUITING
Strasbourg
Germany
Medizinische Hochschule Hannover, Klinik für Augenheilkunde
RECRUITING
Hanover
Universitätsmedizin Rostock
RECRUITING
Rostock
Universitätsklinikum Würzburg, Augenklinik und Poliklinik
RECRUITING
Würzburg
Greece
G.Gennimatas General Hospital of Athens
RECRUITING
Athens
Attikon University General Hospital
RECRUITING
Chaïdári
University General Hospital of Heraklion
RECRUITING
Heraklon
University Hospital of Larissa
RECRUITING
Larissa
Italy
Azienda Ospedaliero - Universitaria di Ferrara - Arcispedale Sant'Anna, Sede Ospedale di Cona;UO di Clinica Oculistica
RECRUITING
Cona (ferrara)
ASST SANTI PAOLO E CARLO - Presidio San Paolo;SC Oculistica
RECRUITING
Milan
Ospedale Monaldi - AORN dei Colli
RECRUITING
Naples
Azienda Ospedaliero-Universitaria Ospedale Maggiore della Carità;S.C.D.U. Oftalmologia
RECRUITING
Novara
A.O.U. Policlinico Paolo Giaccone;Oculistica
RECRUITING
Palermo
Ospedale Isola Tiberina - Gemelli Isola;UOC Chirurgia Vitreoretinica
RECRUITING
Rome
Poland
Szpital sw. Lukasza
RECRUITING
Bielsko-biala
OFTALMIKA Sp. z o.o
RECRUITING
Bydgoszcz
Specjalistyczny O?rodek Okulistyczny Oculomedica
RECRUITING
Bydgoszcz
Niepubliczny Zak?ad Opieki Zdrowotnej PRYZMAT-OKULISTYKA
RECRUITING
Gliwice
MW-med
RECRUITING
Krakow
Klinika Okulistyczna Jasne Błonia Sp. z o. o.
RECRUITING
Lódz
Uniwersytecki Szpital Kliniczny Nr 1 w Lublinie;Klinika Chirurgii Siatkówki i Cia?a Szklistego
RECRUITING
Lublin
Centrum Diagnostyki i Mikrochirurgii Oka LENS
RECRUITING
Olsztyn
Republic of Korea
Kyungpook National University Hospital
RECRUITING
Daegu
Ajou University Medical Center
RECRUITING
Gyeonggi-do
Boramae Medical Center
RECRUITING
Seoul
Hallym University Kangnam Sacred Heart Hospital
RECRUITING
Seoul
Korea University Anam Hospital
RECRUITING
Seoul
Seoul St Mary's Hospital
RECRUITING
Seoul
Severance Hospital, Yonsei University Health System
RECRUITING
Seoul
Spain
Hospital Universitario La Paz
RECRUITING
Madrid
Hospital Universitario Virgen del Rocio
RECRUITING
Seville
Hospital Arnau de Vilanova (Valencia)
RECRUITING
Valencia
Switzerland
Berner Augenklinik
RECRUITING
Bern
Pallas Klinik Olten
RECRUITING
Olten
Kantonsspital St. Gallen
RECRUITING
Sankt Gallen
Thailand
King Chulalongkorn Memorial Hospital
RECRUITING
Bangkok
Rajavithi Hospital
RECRUITING
Bangkok
Maharaj Nakorn ChiangMai Hospital
RECRUITING
Chiang Mai
United Kingdom
Gloucestershire Royal Hospital
RECRUITING
Gloucester
Leicester Royal Infirmary
RECRUITING
Leicester
Moorfields Eye Hospital NHS Foundation Trust
RECRUITING
London
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.
Related Therapeutic Areas
Sponsors
Collaborators: Genentech, Inc.
Leads: Hoffmann-La Roche