Clinical trial Recruiting at 63 sites Phase 3 Interventional Ages 50 and up

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.

More Neovascular Age-related Macular Degeneration trials

Quick facts

PhasePhase 3
Study typeInterventional
Ages50 Years and up
SexAll
Enrollment250 (estimated)
SponsorHoffmann-La Roche
Industry-sponsored
Drugs / interventionsranibizumab, brolucizumab
Locations64 sites (Innsbruck and 63 other locations)
StatusRecruiting
StartedNovember 27, 2025
Main results expectedNovember 15, 2028
Study endsNovember 15, 2028
Registry record updatedNovember 6, 2026
Trial IDNCT06847542 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

  • 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
  • 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.