A Study of 36-Week Refill Exchanges of Port Delivery System (PDS) With Ranibizumab in nAMD
Condition(s) studied
Investigational drug(s) / intervention(s)
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.
Study 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
Primary outcome measure(s)
- Change From Baseline in Best Corrected Visual Acuity (BCVA) Score Averaged Over Weeks 68 and 72, as Assessed Using the Early Treatment Diabetic Retinopathy Study (ETDRS) Chart at a Starting Distance of 4 Meters — Baseline, Week 68, Week 72
BCVA letters were measured using EDTRS chart while participants were at a starting distance of 4 meter. The range of EDTRS is 0 to 100 letters. Higher scores indicate improvement in visual acuity (VA).
Trial sites (61)
| Facility | City | Region | Status |
|---|---|---|---|
| Medizinische Universität Innsbruck | Innsbruck | Austria | Recruiting |
| Kepler Universitätskliniken GmbH - Med Campus III | Linz | Austria | Recruiting |
| Landesklinikum Mistelbach | Mistelbach | Austria | Recruiting |
| Klaudianova Nemocnice - Mlada Boleslav;Ophtalmology dpt | Mladá Boleslav | Czechia | Recruiting |
| Faculty Hospital Ostrava | Ostrava | Czechia | Recruiting |
| Faculty Hospital Kralovske Vinohrady | Prague | Czechia | Recruiting |
| Ustredni vojenska nemocnice | Prague | Czechia | Recruiting |
| Aarhus Universitetshospital | Aarhus N | Denmark | Recruiting |
| Rigshospitalet Glostrup | Glostrup Municipality | Denmark | Recruiting |
| Institut Ophtalmologique De l Ouest Jules Verne | Nantes | Paris | Recruiting |
| Hopital Edouard Herriot - CHU Lyon | Lyon | France | Recruiting |
| Clinique Honore Cave | Montauban | France | Recruiting |
| CHNO des Quinze Vingts | Paris | France | Recruiting |
| CHU Poitiers - CHR La Miletrie | Poitiers | France | Recruiting |
| CHU Strasbourg - Nouvel Hopital Civil | Strasbourg | France | Recruiting |
| Klinikum Chemnitz gGmbH | Chemnitz | Germany | Recruiting |
| Universitätkslinikum Düsseldorf, Augenklinik | Düsseldorf | Germany | Recruiting |
| Universitätsmedizin Göttingen Georg-August-Universität | Göttingen | Germany | Recruiting |
| Medizinische Hochschule Hannover, Klinik für Augenheilkunde | Hanover | Germany | Recruiting |
| Universitätsmedizin Rostock | Rostock | Germany | Recruiting |
| Universitätsklinikum Würzburg, Augenklinik und Poliklinik | Würzburg | Germany | Recruiting |
| "G.Gennimatas" General Hospital of Athens | Athens | Attica | Recruiting |
| Attikon University General Hospital | Chaïdári | Greece | Recruiting |
| University General Hospital of Heraklion | Heraklon | Greece | Recruiting |
| University Hospital of Larissa | Larissa | Greece | Recruiting |
| Ospedale Monaldi - AORN dei Colli | Naples | Campania | Recruiting |
| Azienda Ospedaliero - Universitaria di Ferrara - Arcispedale Sant'Anna, Sede Ospedale di Cona;UO di Clinica Oculistica | Cona (Ferrara) | Emilia-Romagna | Recruiting |
| Ospedale Isola Tiberina - Gemelli Isola;UOC Chirurgia Vitreoretinica | Rome | Lazio | Recruiting |
| ASST SANTI PAOLO E CARLO - Presidio San Paolo;SC Oculistica | Milan | Lombardy | Recruiting |
| Azienda Ospedaliero-Universitaria Ospedale Maggiore della Carità;S.C.D.U. Oftalmologia | Novara | Piedmont | Recruiting |
| A.O.U. Policlinico Paolo Giaccone;Oculistica | Palermo | Sicily | Recruiting |
| MW-med | Krakow | Lesser Poland Voivodeship | Recruiting |
| Szpital sw. Lukasza | Bielsko-Biala | Poland | Recruiting |
| Specjalistyczny O?rodek Okulistyczny Oculomedica | Bydgoszcz | Poland | Recruiting |
| OFTALMIKA Sp. z o.o | Bydgoszcz | Poland | Recruiting |
| Niepubliczny Zak?ad Opieki Zdrowotnej PRYZMAT-OKULISTYKA | Gliwice | Poland | Recruiting |
| SP ZOZ Szpital Uniwersytecki w Krakowie Oddzia? Kliniczny Okulistyki i Onkologii Okulistycznej | Krakow | Poland | Recruiting |
| Klinika Okulistyczna Jasne Błonia Sp. z o. o. | Lódz | Poland | Recruiting |
| Uniwersytecki Szpital Kliniczny Nr 1 w Lublinie;Klinika Chirurgii Siatkówki i Cia?a Szklistego | Lublin | Poland | Recruiting |
| Centrum Diagnostyki i Mikrochirurgii Oka LENS | Olsztyn | Poland | Recruiting |
+ 21 more sites — see the full list on the official registry below.
More Hoffmann-La Roche trials in Italy
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06847542 on ClinicalTrials.gov ↗ ← All trials in Italy