Port Delivery System with ranibizumab refilled every 36 weeks for neovascular (wet) AMD
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
Run by Hoffmann-La Roche · NCT06847542 · Data updated 2026-11-12
This trial tests whether a refillable eye implant that delivers ranibizumab every 36 weeks works and is safe for people with recent neovascular (wet) age-related macular degeneration who responded to prior anti-VEGF injections.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 50 Years and up |
| Sex | All |
| Enrollment | 250 (estimated) |
| Sponsor | Hoffmann-La Roche Industry-sponsored |
| Drugs / interventions | ranibizumab, brolucizumab |
| Locations | 64 sites (Innsbruck and 63 other locations) |
| Status | Recruiting |
| Started | November 27, 2025 |
| Main results expected | November 15, 2028 |
| Study ends | November 15, 2028 |
| Registry record updated | November 6, 2026 |
| Trial ID | NCT06847542 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are people with neovascular AMD diagnosed within 24 months who have shown a response to prior anti-VEGF injections, have available historical OCT and visual acuity data, and meet the minimum visual acuity criteria.
✕Probably not a fit
Patients with a history of vitrectomy, prior intraocular devices, prior intraocular corticosteroid injections, or those who did not respond to anti-VEGF therapy are less likely to benefit from this implant approach.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This Phase 3 interventional trial uses the Susvimo port delivery system (PDS) implanted in the eye and filled with ranibizumab 100 mg/mL, with planned refill exchanges every 36 weeks. Participants must have been diagnosed with nAMD within the past 24 months, have received at least three prior anti-VEGF intravitreal injections with demonstrated response, and have baseline visual acuity of 34 ETDRS letters or better. The study will collect measures of effectiveness, safety, and patient-reported outcomes over the treatment period and will require regular clinic visits for implant procedures, refills, and imaging. Key exclusions include prior vitrectomy, prior intraocular device implantation, or prior intraocular corticosteroid injection in the study eye.
Why it matters
Potential benefit: If successful, the implant could substantially reduce injection frequency and clinic visits by providing longer-term drug delivery while maintaining vision.
How similar studies have gone: Previous PDS trials (for example earlier Phase 3 programs) have shown that ranibizumab delivered via an implant can maintain vision with fewer clinic visits, although device-related complications have also been reported.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
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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
Show 44 more locations
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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, France 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, Greece 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, Italy Recruiting -
Azienda Ospedaliero - Universitaria di Ferrara - Arcispedale Sant'Anna, Sede Ospedale di Cona;UO di Clinica Oculistica
Cona (Ferrara), Emilia-Romagna, Italy Recruiting -
Ospedale Isola Tiberina - Gemelli Isola;UOC Chirurgia Vitreoretinica
Rome, Lazio, Italy Recruiting -
ASST SANTI PAOLO E CARLO - Presidio San Paolo;SC Oculistica
Milan, Lombardy, Italy Recruiting -
Azienda Ospedaliero-Universitaria Ospedale Maggiore della Carità;S.C.D.U. Oftalmologia
Novara, Piedmont, Italy Recruiting -
AOU Città della Salute e della Scienza di Torino
Turin, Piedmont, Italy Recruiting -
A.O.U. Policlinico Paolo Giaccone;Oculistica
Palermo, Sicily, Italy Recruiting -
MW-med
Krakow, Lesser Poland Voivodeship, Poland 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 -
Kyungpook National University Hospital
Daegu, South Korea Recruiting -
Ajou University Medical Center
Gyeonggi-do, South Korea Recruiting -
Severance Hospital, Yonsei University Health System
Seoul, South Korea Recruiting -
Seoul St Mary's Hospital
Seoul, South Korea Recruiting -
Boramae Medical Center
Seoul, South Korea Recruiting -
Hallym University Kangnam Sacred Heart Hospital
Seoul, South Korea Recruiting -
Fundacion Jimenez Diaz-UTE
Madrid, Spain Recruiting -
Hospital Universitario La Paz
Madrid, Spain Recruiting -
Hospital Universitario Virgen del Rocio
Seville, Spain Recruiting
+14 more sites. See ClinicalTrials.gov for the full list.
Study contacts
- Study coordinator: Reference Study ID Number: MR45625 https://forpatients.roche.com/ No attachments to email below.
- Email: global-roche-genentech-trials@gene.com
- Phone: 888-662-6728 (U.S.)
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.