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A Study of 36-Week Refill Exchanges of Port Delivery System (PDS) With Ranibizumab in nAMD
Sponsor: Hoffmann-La Roche
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.
Official title: 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
Key Details
Gender
All
Age Range
50 Years - Any
Study Type
INTERVENTIONAL
Enrollment
250
Start Date
2025-11-27
Completion Date
2028-10-12
Last Updated
2026-03-30
Healthy Volunteers
No
Interventions
Susvimo PDS Implant
Ranizumab will be administered via a PDS implant per the schedule described in the arm.
Ranibizumab
Participants will receive ranibizumab delivered through the PDS implant. Participants will receive ranibizumab, 0.5 mg IVT injections as a supplemental treatment.
Locations (53)
Medizinische Universität Innsbruck
Innsbruck, Austria
Kepler Universitätskliniken GmbH - Med Campus III
Linz, Austria
Landesklinikum Mistelbach
Mistelbach, Austria
Klaudianova Nemocnice - Mlada Boleslav;Ophtalmology dpt
Mladá Boleslav, Czechia
Faculty Hospital Ostrava
Ostrava, Czechia
Aarhus Universitetshospital
Aarhus N, Denmark
Rigshospitalet Glostrup
Glostrup Municipality, Denmark
Institut Ophtalmologique De l Ouest Jules Verne
Nantes, Paris, France
Hopital Edouard Herriot - CHU Lyon
Lyon, France
Clinique Honore Cave
Montauban, France
CHNO des Quinze Vingts
Paris, France
CHU Poitiers - CHR La Miletrie
Poitiers, France
CHU Strasbourg - Nouvel Hopital Civil
Strasbourg, France
Medizinische Hochschule Hannover, Klinik für Augenheilkunde
Hanover, Germany
Universitätsmedizin Rostock
Rostock, Germany
Universitätsklinikum Würzburg, Augenklinik und Poliklinik
Würzburg, Germany
"G.Gennimatas" General Hospital of Athens
Athens, Attica, Greece
Attikon University General Hospital
Chaïdári, Greece
University General Hospital of Heraklion
Heraklon, Greece
University Hospital of Larissa
Larissa, Greece
Ospedale Monaldi - AORN dei Colli
Naples, Campania, Italy
Azienda Ospedaliero - Universitaria di Ferrara - Arcispedale Sant'Anna, Sede Ospedale di Cona;UO di Clinica Oculistica
Cona (Ferrara), Emilia-Romagna, Italy
Ospedale Isola Tiberina - Gemelli Isola;UOC Chirurgia Vitreoretinica
Rome, Lazio, Italy
ASST SANTI PAOLO E CARLO - Presidio San Paolo;SC Oculistica
Milan, Lombardy, Italy
Azienda Ospedaliero-Universitaria Ospedale Maggiore della Carità;S.C.D.U. Oftalmologia
Novara, Piedmont, Italy
A.O.U. Policlinico Paolo Giaccone;Oculistica
Palermo, Sicily, Italy
MW-med
Krakow, Lesser Poland Voivodeship, Poland
Szpital sw. Lukasza
Bielsko-Biala, Poland
Specjalistyczny O?rodek Okulistyczny Oculomedica
Bydgoszcz, Poland
OFTALMIKA Sp. z o.o
Bydgoszcz, Poland
Niepubliczny Zak?ad Opieki Zdrowotnej PRYZMAT-OKULISTYKA
Gliwice, Poland
Klinika Okulistyczna Jasne Błonia Sp. z o. o.
Lódz, Poland
Uniwersytecki Szpital Kliniczny Nr 1 w Lublinie;Klinika Chirurgii Siatkówki i Cia?a Szklistego
Lublin, Poland
Centrum Diagnostyki i Mikrochirurgii Oka LENS
Olsztyn, Poland
Kyungpook National University Hospital
Daegu, South Korea
Ajou University Medical Center
Gyeonggi-do, South Korea
Korea University Anam Hospital
Seoul, South Korea
Severance Hospital, Yonsei University Health System
Seoul, South Korea
Seoul St Mary's Hospital
Seoul, South Korea
Boramae Medical Center
Seoul, South Korea
Hallym University Kangnam Sacred Heart Hospital
Seoul, South Korea
Hospital Universitario La Paz
Madrid, Spain
Hospital Universitario Virgen del Rocio
Seville, Spain
Hospital Arnau de Vilanova (Valencia)
Valencia, Spain
Berner Augenklinik
Bern, Switzerland
Pallas Klinik Olten
Olten, Switzerland
Kantonsspital St. Gallen
Sankt Gallen, Switzerland
King Chulalongkorn Memorial Hospital
Bangkok, Thailand
Rajavithi Hospital
Bangkok, Thailand
Maharaj Nakorn ChiangMai Hospital
Chiang Mai, Thailand
Leicester Royal Infirmary
Leicester, Leicestershire, United Kingdom
Gloucestershire Royal Hospital
Gloucester, United Kingdom
Moorfields Eye Hospital NHS Foundation Trust
London, United Kingdom