RecruitingPhase 3NCT06847542

A Study of 36-Week Refill Exchanges of Port Delivery System (PDS) With Ranibizumab in nAMD

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

Sponsor

Hoffmann-La Roche

Enrollment

250 participants

Start Date

Nov 27, 2025

Study Type

INTERVENTIONAL

Conditions

Neovascular Age-related Macular Degeneration

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

Min Age: 50 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Ranibizumab and a medical device called Susvimo PDS Implant for people with neovascular age-related macular degeneration. The study is currently recruiting participants at 57 locations. People eligible for this study include aged 50 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICESusvimo PDS Implant

Ranizumab will be administered via a PDS implant per the schedule described in the arm.

DRUGRanibizumab

Participants will receive ranibizumab delivered through the PDS implant. Participants will receive ranibizumab, 0.5 mg IVT injections as a supplemental treatment.

Locations(59)

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

Ustredni vojenska nemocnice

Prague, 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

Klinikum Chemnitz gGmbH

Chemnitz, Germany

Universitätkslinikum Düsseldorf, Augenklinik

Düsseldorf, Germany

Universitätsmedizin Göttingen Georg-August-Universität

Göttingen, Germany

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

Ramathibodi Hospital

Bangkok, Thailand

Maharaj Nakorn ChiangMai Hospital

Chiang Mai, Thailand

Songklanagarind Hospital

Songkhla, Thailand

Leicester Royal Infirmary

Leicester, Leicestershire, United Kingdom

Gloucestershire Royal Hospital

Gloucester, United Kingdom

Moorfields Eye Hospital NHS Foundation Trust

London, United Kingdom

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NCT06847542

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