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

NCT06847542 | Recruiting Phase 3 FDA Drug FDA Device

• 2 other identifiers: MR456252024-516924-32-00
• Study Type: interventional
• Target: 250
• Locations: 13 countries
• Sites: 56

Brief 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.

Conditions

Neovascular Age-related Macular Degeneration

Outcome Measures

Primary Outcomes (1)

• 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

  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).

  Baseline, Week 68, Week 72

Secondary Outcomes (14)

• Change From Baseline in BCVA Score Over Time

  From baseline up to Week 72

• Percentage of Participants Who Lose ≤ 15, ≤ 10, ≤ 5, or Gain ≥ 0 Letters in BCVA Score From Baseline Over Time

  From baseline up to Week 72

• Change From Baseline in Center Point Thickness (CPT)

  From baseline up to Week 72

• Change From Baseline in Central Subfield Thickness (CST)

  From baseline up to Week 72

• Proportion of Participants Who do not Undergo Supplemental Treatment With IVT Ranibizumab Before Each Refill-exchange Procedure

  Up to Week 72

Study Arms (1)

Port Delivery System (PDS)

EXPERIMENTAL

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.

Device: Susvimo PDS Implant; Drug: Ranibizumab

Interventions

Susvimo PDS Implant DEVICE

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

Also known as: RO4893594

Port Delivery System (PDS)

Ranibizumab DRUG

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

Also known as: RO4893594

Port Delivery System (PDS)

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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:

Sponsors & Collaborators

• Hoffmann-La Roche: lead
• Genentech, Inc.: collaborator

Study Sites (56)

Medizinische Universität Innsbruck

Innsbruck, 6020, Austria

RECRUITING

Kepler Universitätskliniken GmbH - Med Campus III

Linz, 4021, Austria

RECRUITING

Landesklinikum Mistelbach

Mistelbach, 2130, Austria

RECRUITING

Klaudianova Nemocnice - Mlada Boleslav;Ophtalmology dpt

Mladá Boleslav, 293 50, Czechia

RECRUITING

Faculty Hospital Ostrava

Ostrava, 708 52, Czechia

RECRUITING

Aarhus Universitetshospital

Aarhus N, 8200, Denmark

RECRUITING

Rigshospitalet Glostrup

Glostrup Municipality, 2600, Denmark

RECRUITING

Institut Ophtalmologique De l Ouest Jules Verne

Nantes, Paris, 44300, France

RECRUITING

Hopital Edouard Herriot - CHU Lyon

Lyon, 69003, France

RECRUITING

Clinique Honore Cave

Montauban, 82000, France

RECRUITING

CHNO des Quinze Vingts

Paris, 75012, France

RECRUITING

CHU Poitiers - CHR La Miletrie

Poitiers, 86021, France

RECRUITING

CHU Strasbourg - Nouvel Hopital Civil

Strasbourg, 67091, France

RECRUITING

Klinikum Chemnitz gGmbH

Chemnitz, 09116, Germany

RECRUITING

Universitätkslinikum Düsseldorf, Augenklinik

Düsseldorf, 40225, Germany

RECRUITING

Universitätsmedizin Göttingen Georg-August-Universität

Göttingen, 37075, Germany

RECRUITING

Medizinische Hochschule Hannover, Klinik für Augenheilkunde

Hanover, 30625, Germany

RECRUITING

Universitätsmedizin Rostock

Rostock, 18057, Germany

RECRUITING

Universitätsklinikum Würzburg, Augenklinik und Poliklinik

Würzburg, 97080, Germany

RECRUITING

"G.Gennimatas" General Hospital of Athens

Athens, Attica, 115 27, Greece

RECRUITING

Attikon University General Hospital

Chaïdári, 124 62, Greece

RECRUITING

University General Hospital of Heraklion

Heraklon, 711 10, Greece

RECRUITING

University Hospital of Larissa

Larissa, 412 21, Greece

RECRUITING

Ospedale Monaldi - AORN dei Colli

Naples, Campania, 80131, Italy

RECRUITING

Azienda Ospedaliero - Universitaria di Ferrara - Arcispedale Sant'Anna, Sede Ospedale di Cona;UO di Clinica Oculistica

Cona (Ferrara), Emilia-Romagna, 44122, Italy

RECRUITING

Ospedale Isola Tiberina - Gemelli Isola;UOC Chirurgia Vitreoretinica

Rome, Lazio, 00186, Italy

RECRUITING

ASST SANTI PAOLO E CARLO - Presidio San Paolo;SC Oculistica

Milan, Lombardy, 20142, Italy

RECRUITING

Azienda Ospedaliero-Universitaria Ospedale Maggiore della Carità;S.C.D.U. Oftalmologia

Novara, Piedmont, 28100, Italy

RECRUITING

A.O.U. Policlinico Paolo Giaccone;Oculistica

Palermo, Sicily, 90142, Italy

RECRUITING

MW-med

Krakow, Lesser Poland Voivodeship, 31 416, Poland

RECRUITING

Szpital sw. Lukasza

Bielsko-Biala, 43-309, Poland

RECRUITING

Specjalistyczny O?rodek Okulistyczny Oculomedica

Bydgoszcz, 85-316, Poland

RECRUITING

OFTALMIKA Sp. z o.o

Bydgoszcz, 85-631, Poland

RECRUITING

Niepubliczny Zak?ad Opieki Zdrowotnej PRYZMAT-OKULISTYKA

Gliwice, 44-100, Poland

RECRUITING

Klinika Okulistyczna Jasne Błonia Sp. z o. o.

Lódz, 91-134, Poland

RECRUITING

Uniwersytecki Szpital Kliniczny Nr 1 w Lublinie;Klinika Chirurgii Siatkówki i Cia?a Szklistego

Lublin, 20-079, Poland

RECRUITING

Centrum Diagnostyki i Mikrochirurgii Oka LENS

Olsztyn, 10-424, Poland

RECRUITING

Kyungpook National University Hospital

Daegu, 41944, South Korea

RECRUITING

Ajou University Medical Center

Gyeonggi-do, 16499, South Korea

RECRUITING

Korea University Anam Hospital

Seoul, 02841, South Korea

RECRUITING

Severance Hospital, Yonsei University Health System

Seoul, 03722, South Korea

RECRUITING

Seoul St Mary's Hospital

Seoul, 06591, South Korea

RECRUITING

Boramae Medical Center

Seoul, 07061, South Korea

RECRUITING

Hallym University Kangnam Sacred Heart Hospital

Seoul, 07441, South Korea

RECRUITING

Hospital Universitario La Paz

Madrid, 28046, Spain

RECRUITING

Hospital Universitario Virgen del Rocio

Seville, 41013, Spain

RECRUITING

Hospital Arnau de Vilanova (Valencia)

Valencia, 46015, Spain

RECRUITING

Berner Augenklinik

Bern, 3007, Switzerland

RECRUITING

Pallas Klinik Olten

Olten, 4600, Switzerland

RECRUITING

Kantonsspital St. Gallen

Sankt Gallen, 9007, Switzerland

RECRUITING

King Chulalongkorn Memorial Hospital

Bangkok, 10330, Thailand

RECRUITING

Rajavithi Hospital

Bangkok, 10400, Thailand

RECRUITING

Maharaj Nakorn ChiangMai Hospital

Chiang Mai, 50200, Thailand

RECRUITING

Leicester Royal Infirmary

Leicester, Leicestershire, LE1 5WW, United Kingdom

RECRUITING

Gloucestershire Royal Hospital

Gloucester, GL1 3NN, United Kingdom

RECRUITING

Moorfields Eye Hospital NHS Foundation Trust

London, EC1V 2PD, United Kingdom

RECRUITING

MeSH Terms

Interventions

Ranibizumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Central Study Contacts

Reference Study ID Number: MR45625 https://forpatients.roche.com/

CONTACT

888-662-6728 (U.S.); global-roche-genentech-trials@gene.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Masking Details: The outcome assessor (Visual acuity assessor) will be blinded. * The best corrected visual acuity (BCVA) examiner will only conduct refraction and BCVA assessments and will be masked to participant study eye assignment and study visit type. * The BCVA examiner will have no access to a participant's BCVA scores from previous visits and will be aware only of the participant's refraction data from previous visits. * The BCVA examiner may provide no other direct or indirect participant care.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is a Phase 3b study.

Study Record Dates

• First Submitted: February 21, 2025
• First Posted: February 26, 2025
• Study Start: November 27, 2025
• Primary Completion (Estimated): September 12, 2028
• Study Completion (Estimated): October 12, 2028
• Last Updated: April 27, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

KR (7); GB (3); FR (6); CH (3); IT (6); CZ (2); AU (3); GR (4); DE (6); DK (2); PL (8); TH (3); ES (3)