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New eye implant could cut wet AMD treatments to twice a year

NCT ID NCT06847542

Disease control Sponsor: Hoffmann-La Roche Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 21, 2026 · Updated 3 times

Summary

This study tests a refillable eye implant (Port Delivery System) that slowly releases the drug ranibizumab to treat wet age-related macular degeneration. The implant is refilled every 36 weeks, potentially reducing the need for frequent eye injections. About 250 participants who have already responded to standard injections will receive the implant and be followed for safety and vision outcomes.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
ranibizumab
What this could lead to
If successful, this could offer a convenient treatment option for wet AMD, requiring fewer doctor visits for eye injections.
What could go wrong
This is a single-arm study without a comparison group, so results may be less definitive. The implant requires a surgical procedure and may carry risks like infection or device issues.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 250 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2025

Expected to finish

Nov 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

50 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

wet macular degeneration

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Neovascular age-related macular degeneration

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    60 sites in 13 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • "G.Gennimatas" General Hospital of Athens

    RECRUITING

    Athens, Attica, 115 27, Greece

  • A.O.U. Policlinico Paolo Giaccone;Oculistica

    RECRUITING

    Palermo, Sicily, 90142, Italy

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

    RECRUITING

    Milan, Lombardy, 20142, Italy

  • Aarhus Universitetshospital

    RECRUITING

    Aarhus N, 8200, Denmark

  • Ajou University Medical Center

    RECRUITING

    Gyeonggi-do, 16499, South Korea

  • Attikon University General Hospital

    RECRUITING

    Chaïdári, 124 62, Greece

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

    RECRUITING

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

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

    RECRUITING

    Novara, Piedmont, 28100, Italy

  • Berner Augenklinik

    RECRUITING

    Bern, 3007, Switzerland

  • Boramae Medical Center

    RECRUITING

    Seoul, 07061, South Korea

  • CHNO des Quinze Vingts

    RECRUITING

    Paris, 75012, France

  • CHU Poitiers - CHR La Miletrie

    RECRUITING

    Poitiers, 86021, France

  • CHU Strasbourg - Nouvel Hopital Civil

    RECRUITING

    Strasbourg, 67091, France

  • Centrum Diagnostyki i Mikrochirurgii Oka LENS

    RECRUITING

    Olsztyn, 10-424, Poland

  • Clinique Honore Cave

    RECRUITING

    Montauban, 82000, France

  • Faculty Hospital Kralovske Vinohrady

    RECRUITING

    Prague, 100 34, Czechia

  • Faculty Hospital Ostrava

    RECRUITING

    Ostrava, 708 52, Czechia

  • Gloucestershire Royal Hospital

    RECRUITING

    Gloucester, GL1 3NN, United Kingdom

  • Hallym University Kangnam Sacred Heart Hospital

    RECRUITING

    Seoul, 07441, South Korea

  • Hopital Edouard Herriot - CHU Lyon

    RECRUITING

    Lyon, 69003, France

  • Hospital Arnau de Vilanova (Valencia)

    RECRUITING

    Valencia, 46015, Spain

  • Hospital Universitario La Paz

    RECRUITING

    Madrid, 28046, Spain

  • Hospital Universitario Virgen del Rocio

    RECRUITING

    Seville, 41013, Spain

  • Institut Ophtalmologique De l Ouest Jules Verne

    RECRUITING

    Nantes, Paris, 44300, France

  • Kantonsspital St. Gallen

    RECRUITING

    Sankt Gallen, 9007, Switzerland

  • Kepler Universitätskliniken GmbH - Med Campus III

    RECRUITING

    Linz, 4021, Austria

  • King Chulalongkorn Memorial Hospital

    RECRUITING

    Bangkok, 10330, Thailand

  • Klaudianova Nemocnice - Mlada Boleslav;Ophtalmology dpt

    RECRUITING

    Mladá Boleslav, 293 50, Czechia

  • Klinika Okulistyczna Jasne Błonia Sp. z o. o.

    RECRUITING

    Lódz, 91-134, Poland

  • Klinikum Chemnitz gGmbH

    RECRUITING

    Chemnitz, 09116, Germany

  • Korea University Anam Hospital

    RECRUITING

    Seoul, 02841, South Korea

  • Kyungpook National University Hospital

    RECRUITING

    Daegu, 41944, South Korea

  • Landesklinikum Mistelbach

    RECRUITING

    Mistelbach, 2130, Austria

  • Leicester Royal Infirmary

    RECRUITING

    Leicester, Leicestershire, LE1 5WW, United Kingdom

  • MW-med

    RECRUITING

    Krakow, Lesser Poland Voivodeship, 31 416, Poland

  • Maharaj Nakorn ChiangMai Hospital

    RECRUITING

    Chiang Mai, 50200, Thailand

  • Medizinische Hochschule Hannover, Klinik für Augenheilkunde

    RECRUITING

    Hanover, 30625, Germany

  • Medizinische Universität Innsbruck

    RECRUITING

    Innsbruck, 6020, Austria

  • Moorfields Eye Hospital NHS Foundation Trust

    RECRUITING

    London, EC1V 2PD, United Kingdom

  • Niepubliczny Zak?ad Opieki Zdrowotnej PRYZMAT-OKULISTYKA

    RECRUITING

    Gliwice, 44-100, Poland

  • OFTALMIKA Sp. z o.o

    RECRUITING

    Bydgoszcz, 85-631, Poland

  • Ospedale Isola Tiberina - Gemelli Isola;UOC Chirurgia Vitreoretinica

    RECRUITING

    Rome, Lazio, 00186, Italy

  • Ospedale Monaldi - AORN dei Colli

    RECRUITING

    Naples, Campania, 80131, Italy

  • Pallas Klinik Olten

    RECRUITING

    Olten, 4600, Switzerland

  • Rajavithi Hospital

    RECRUITING

    Bangkok, 10400, Thailand

  • Ramathibodi Hospital

    RECRUITING

    Bangkok, 10400, Thailand

  • Rigshospitalet Glostrup

    RECRUITING

    Glostrup Municipality, 2600, Denmark

  • Seoul St Mary's Hospital

    RECRUITING

    Seoul, 06591, South Korea

  • Severance Hospital, Yonsei University Health System

    RECRUITING

    Seoul, 03722, South Korea

  • Songklanagarind Hospital

    RECRUITING

    Songkhla, 90110, Thailand

  • Specjalistyczny O?rodek Okulistyczny Oculomedica

    RECRUITING

    Bydgoszcz, 85-316, Poland

  • Szpital sw. Lukasza

    RECRUITING

    Bielsko-Biala, 43-309, Poland

  • University General Hospital of Heraklion

    RECRUITING

    Heraklon, 711 10, Greece

  • University Hospital of Larissa

    RECRUITING

    Larissa, 412 21, Greece

  • Universitätkslinikum Düsseldorf, Augenklinik

    RECRUITING

    Düsseldorf, 40225, Germany

  • Universitätsklinikum Würzburg, Augenklinik und Poliklinik

    RECRUITING

    Würzburg, 97080, Germany

  • Universitätsmedizin Göttingen Georg-August-Universität

    RECRUITING

    Göttingen, 37075, Germany

  • Universitätsmedizin Rostock

    RECRUITING

    Rostock, 18057, Germany

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

    RECRUITING

    Lublin, 20-079, Poland

  • Ustredni vojenska nemocnice

    RECRUITING

    Prague, 169 02, Czechia

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