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Clinical Trials in the UK / NCT06847542
Recruiting Phase 3

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

NCT06847542 · tracked via the Priya Life Science UK tracker
Sponsor
Hoffmann-La Roche
Phase
Phase 3
Started
2025-11-27
Last updated
2026-08-21

Condition(s) studied

Neovascular Age-related Macular Degeneration

Investigational drug(s) / intervention(s)

Susvimo PDS ImplantRanibizumab

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

Sex
ALL
Min age
50 Years
Max age
Healthy volunteers
No
Inclusion Criteria: * 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 Exclusion Criteria: A. Prior Ocular Treatment Study Eye: * History of vitrectomy surgery, submacular surgery, or other surgical intervention for age-related macular degeneration (AMD) * Previous treatment with corticosteroid intravitreal injection * Previous intraocular device implantation * History of vitreous hemorrhage * History of rhegmatogenous retinal detachment * History of glaucoma-filtering surgery, tube shunts, or microinvasive glaucoma surgery * History of corneal transplant Either Eye: * History of a severe allergic reaction or anaphylactic reaction to a biologic agent or known hypersensitivity to any component of the ranibizumab injections, study-related procedure preparations (including fluorescein), dilating drops, or any of the anesthetic and antimicrobial preparations used by a participant during the study * Prior participation in a clinical trial involving any experimental therapies for nAMD * Prior treatment with brolucizumab or gene therapy for nAMD B. Macular Neovascularization/Choroidal Neovascularization (MNV/CNV) Lesion Characteristics: Study Eye: * Subretinal hemorrhage that involves the center of the fovea * Subfoveal fibrosis or subfoveal atrophy Either Eye: * CNV due to other causes, such as ocular histoplasmosis, trauma, central serous chorioretinopathy, or pathologic myopia * CNV masquerading lesions C. Concurrent Ocular Conditions: Study Eye: * Subfoveal and/or juxtafoveal retinal pigment epithelial tear * Any concurrent intraocular condition that would either require surgical intervention during the study to prevent or treat visual loss that might result from that condition or affect interpretation of study results * Active intraocular inflammation * Retinal tears or peripheral retinal breaks on depressed fundus exam that are untreated or treated within 3 months prior to the enrollment visit * Aphakia or absence of the posterior capsule * Uncontrolled ocular hypertension or glaucoma * History or presence of severe posterior blepharitis, recurrent chalazia or hordeolum, severe dry eye syndrome, or severe allergic conjunctivitis * Trichiasis * Corneal neuropathy * Lagophthalmos or incomplete blink * Active or history of facial nerve palsy/paresis Fellow (Non-study) Eye: \- Non-functioning non-study eye defined as either: BCVA of hand motion or worse OR no physical presence of non-study eye (i.e., monocular) Either Eye: * Any active or history of uveitis * Active or history of keratitis, scleritis, endophthalmitis, or chronic blepharitis * Suspected or active ocular or periocular infectious conjunctivitis or endophthalmitis * Active or history of floppy eyelid syndrome * Active thyroid eye disease D. Concurrent Systemic Conditions: * Uncontrolled blood pressure * Active or history of autoimmune diseases * History of stroke within the last 3 months prior to informed consent * Atrial fibrillation diagnosed or worsened within the last 3 months prior to informed consent * History of myocardial infarction (MI) within the last 3 months prior to informed consent * Confirmed active systemic infection * History of other disease, metabolic dysfunction, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of ranibizumab or placement of the implant and that might affect interpretation of the results of the study * Use of any systemic anti-VEGF agents * Chronic use of oral corticosteroids * Active cancer within 12 months of enrollment except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, and prostate cancer

Primary outcome measure(s)

Trial sites (60)

FacilityCityRegionStatus
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
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
Kyungpook National University Hospital Daegu South Korea Recruiting

+ 20 more sites — see the full list on the official registry below.

More Hoffmann-La Roche trials in the UK

Other trials for the same condition

Official registry record

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 the UK