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New eye implant could cut treatment visits to twice a year for wet AMD

NCT ID NCT04657289

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

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jul 31, 2026 · Updated 2 times

Summary

This phase 3 trial tests whether a refillable eye implant delivering ranibizumab can be safely used every 36 weeks instead of every 24 weeks for people with wet age-related macular degeneration. About 451 participants who have already responded to standard injections will receive the implant and be followed for over a year. The goal is to see if the longer interval keeps vision stable while reducing how often patients need treatment.

What this could mean

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

Active substance
ranibizumab delivered via a port delivery system implant
What this could lead to
If successful, this could allow people with wet AMD to go 36 weeks between refills, reducing the need for frequent eye injections.
What could go wrong
This is a late-stage trial, but it compares two refill schedules rather than a new drug. The longer interval may not work as well for everyone, and implant-related risks like infection or inflammation remain.

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

451 people

The number who actually took part.

Started

Jul 2021

Expected to finish

Feb 2027

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: * Age ≥ 50 years at time of signing Informed Consent Form * Initial diagnosis of nAMD within 9 months prior to the screening visit * Previous treatment with at least three anti- vascular endothelial growth factor (VEGF) intravitreal injections for nAMD per standard of care within 6 months prior to the screening visit * Demonstrated response to prior anti-VEGF intravitreal treatment since diagnosis * Availability of historical visual acuity data prior to the first anti-VEGF treatment for nAMD until the time of study enrollment * BCVA of 34 letters (approximate 20/200 Snellen equivalent) or better Exclusion Criteria: * History of vitrectomy surgery, submacular surgery, or other surgical intervention for AMD in study eye * Prior treatment with Visudyne®, external-beam radiation therapy, or transpupillary thermotherapy in study eye * Previous treatment with corticosteroid intravitreal injection, intraocular device implantation, previous laser (any type) used for AMD treatment in study eye * Treatment with anti-VEGF agents other than ranibizumab within 1 month prior to the enrollment visit in study eye * Concurrent conjunctival, Tenon's capsule, and/or scleral condition in the supero-temporal quadrant of the eye that may affect the implantation, subsequent tissue coverage, and refill-exchange procedure of the PDS implant * Prior treatment with brolucizumab (at any time prior to the screening visit) in either eye * Prior participation in a clinical trial involving any anti-VEGF drugs, within 9 months prior to the enrollment visit in either eye * Subretinal hemorrhage that involves the center of the fovea, if the hemorrhage is \>0.5 disc area at screening in study eye * Subfoveal fibrosis or subfoveal atrophy in study eye * Choroidal neovascularization (CNV) due to other causes, such as ocular histoplasmosis, trauma, central serous chorio-retinopathy, or pathologic myopia in either eye * Retinal pigment epithelial tear in study eye * 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 in study eye * Active intraocular inflammation in study eye * History of vitreous hemorrhage in study eye * History of rhegmatogenous retinal detachment in study eye * History of retinal tears or peripheral retinal breaks within 3 months prior to the enrollment visit in study eye * History of pars plana vitrectomy surgery * Aphakia or absence of the posterior capsule in study eye * Spherical equivalent of the refractive error demonstrating more than 8 diopters of myopia in study eye * Preoperative refractive error that exceeded 8 diopters of myopia, for Participants who have undergone prior refractive or cataract surgery in study eye * Intraocular surgery within 3 months preceding the enrollment visit in study eye * Uncontrolled ocular hypertension or glaucoma and any such condition the investigator determines may require a glaucoma-filtering surgery during a participant's participation in the study in study eye * History of glaucoma-filtering surgery, tube shunts, or microinvasive glaucoma surgery in study eye * History of corneal transplant in study eye * Any history of uveitis requiring treatment in either eye * Active infectious conjunctivitis, keratitis, scleritis, or endophthalmitis in either eye * Uncontrolled blood pressure * 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 within the last 3 months prior to informed consent, * 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 or renders the participant at high risk of treatment complications in the opinion of the investigator * Confirmed active systemic infection * Use of any systemic anti-VEGF agents * Active cancer within 12 months of enrollment except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, and prostate cancer with a Gleason score of \<= 6 and a stable prostate-specific antigen for \> 12 months * Previous participation in any non-ocular disease studies of investigational drugs within 1 month preceding the informed consent * Non-functioning non-study eye

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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 (NAMD)

Contacts and locations

Locations

  • A.O. Universitaria S. Maria Della Misericordia Di Udine

    Udine, Veneto, 33100, Italy

  • Ankara Bilkent City Hospital

    Ankara, 06490, Turkey (Türkiye)

  • Ankara Etlik City Hospital

    Ankara, Turkey (Türkiye)

  • Asan Medical Center

    Seoul, 05505, South Korea

  • Asst Fatebenefratelli Sacco

    Milan, Lombardy, 20157, Italy

  • Augenabteilung am St. Franziskus-Hospital

    Münster, 48145, Germany

  • Azienda Ospedaliera di Perugia Ospedale S. Maria Della Misericordia

    Perugia, Umbria, 06129, Italy

  • Azienda Ospedaliero Universitaria "Ospedali Riuniti" Trieste-Ospedale Maggiore

    Trieste, Friuli Venezia Giulia, 34129, Italy

  • Azienda Ospedaliero Universitaria Ospedali Riuniti

    Torrette - Ancona, The Marches, 60126, Italy

  • Azienda Ospedaliero-Universitaria Careggi

    Florence, Tuscany, 50134, Italy

  • Beyoglu Goz Training and Research Hospital

    Istanbul, 34421, Turkey (Türkiye)

  • Botelho Hospital da Visao

    Blumenau, Santa Catarina, 89052-504, Brazil

  • Bristol Eye Hospital

    Bristol, BS1 2LX, United Kingdom

  • Central Middlesex Hospital

    London, NW10 7NS, United Kingdom

  • Centre For Eye Research Australia

    East Melbourne, Victoria, 3002, Australia

  • Centre Paradis Monticelli

    Marseille, 13008, France

  • Centre Retine Gallien

    Bordeaux, 33000, France

  • Centro Oftalmologico Dr. Charles S.A.

    Capital Federal, C1116, Argentina

  • Centro de Oftalmologia Barraquer

    Barcelona, 08021, Spain

  • Chang Gung Medical Foundation - Linkou

    Taoyuan, 333, Taiwan

  • Changhua Christian Hospital

    Changhua, 500, Taiwan

  • Clinica Baviera

    Madrid, 28046, Spain

  • Clinica Universitaria de Navarra

    Pamplona, Navarre, 31008, Spain

  • Eye and Retina Consultants

    Hurstville, New South Wales, 2220, Australia

  • Eyeclinic Albury Wodonga

    Albury, New South Wales, 2640, Australia

  • Fondation Asile Des Aveugles ? Jules Gonin Eye Hospital

    Lausanne, Switzerland

  • Fondation Rothschild

    Paris, 75940, France

  • Fondazione G.B. Bietti Per Lo Studio E La Ricerca in Oftalmologia-Presidio Ospedaliero Britannico

    Rome, Lazio, 00198, Italy

  • Fondazione Irccs Ca' Granda Ospedale Maggiore Policlinico-Clinica Regina Elena

    Milan, Lombardy, 20100, Italy

  • Gachon University Gil Medical Center

    Incheon, 21565, South Korea

  • Grupo Laser Vision

    Rosario, S2000DLA, Argentina

  • Hacettepe University Medical Faculty

    Ankara, 06100, Turkey (Türkiye)

  • Hadassah MC

    Jerusalem, 9112001, Israel

  • Hopital Lariboisiere

    Paris, 75010, France

  • Hopital de la croix rousse

    Lyon, 69317, France

  • Hosp de Olhos de Sorocaba

    Sorocaba, São Paulo, 18031-060, Brazil

  • Hospital General de Catalunya

    San Cugat Del Valles, Barcelona, 08195, Spain

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035, Spain

  • Hospital Universitario Puerta de Hierro

    Majadahonda, Madrid, 28222, Spain

  • Hospital Universitario de Bellvitge

    L'Hospitalet de Llobregat, Barcelona, 08907, Spain

  • Hospital das Clinicas - UFRGS

    Porto Alegre, Rio Grande do Sul, Brazil

  • Hospital de la Arruzafa. Servicio de Oftalmologia

    Córdoba, 14012, Spain

  • Hospital dos de maig

    Barcelona, 08025, Spain

  • Inselspital Bern Ophthalmologische Klinik

    Bern, 3010, Switzerland

  • Institut de la Macula i la retina

    Barcelona, 08022, Spain

  • Instituto Oftalmologico Fernandez Vega

    Oviedo, Principality of Asturias, 33012, Spain

  • Instituto da Visao IPEPO

    São Paulo, São Paulo, 04038-032, Brazil

  • Irccs Ospedale San Raffaele

    Milan, Lombardy, 20132, Italy

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

    Kaohsiung City, Taiwan

  • Kaplan Medical Center

    Rehovot, 7660101, Israel

  • Kings College Hospital

    London, SE5 9RS, United Kingdom

  • Klinikum der Stadt Ludwigshafen am Rhein gGmbH

    Ludwigshafen, 67063, Germany

  • Knappschaftsklinikum Saar GmbH

    Sulzbach, 66280, Germany

  • Kocaeli Universitesi T?p Fakultesi

    Kocaeli, 41380, Turkey (Türkiye)

  • Kyung Hee University Hospital

    Seoul, 02447, South Korea

  • LKH-Univ.Klinikum Graz

    Graz, 8036, Austria

  • LMU Klinikum der Universitat, Augenklinik

    München, 80336, Germany

  • Medizinische Universitat Lausitz ? Carl Thiem

    Cottbus, 03048, Germany

  • Medizinische Universitat Wien

    Vienna, 1090, Austria

  • Meir Medical Center

    Kfar Saba, 4428164, Israel

  • Moorfields Eye Hospital NHS Foundation Trust

    London, EC1V 2PD, United Kingdom

  • National Taiwan University Hospital

    Zhongzheng Dist., 10002, Taiwan

  • National University Hospital

    Singapore, 119074, Singapore

  • New Cross Hospital

    Wolverhampton, WV10 0QP, United Kingdom

  • Oftalmos

    Capital Federal, C1120AAN, Argentina

  • Oftalvist Valencia

    Valencia, 46004, Spain

  • Ospedale Classificato Equiparato Sacro Cuore ? Don Calabria

    Negrar - Verona, Veneto, 37024, Italy

  • Ospedale Clinicizzato SS Annunziata

    Chieti, Abruzzo, 66100, Italy

  • Policlinico Universitario Agostino Gemelli

    Rome, Lazio, 00168, Italy

  • Policlinico di Bari

    Bari, Apulia, 70124, Italy

  • Pusan National University Hospital

    Busan, 49241, South Korea

  • Queensland Eye Institute

    Woolloongabba, Queensland, 4102, Australia

  • Rabin MC

    Petah Tikva, 4941492, Israel

  • Rambam Medical Center

    Haifa, 3109601, Israel

  • Retina Associates Liverpool

    Liverpool, New South Wales, 2170, Australia

  • Retina Clinic

    São Paulo, São Paulo, 01427-002, Brazil

  • Retina Specialists Victoria

    Rowville, Victoria, 3178, Australia

  • Retina and Macula Specialists

    Miranda, New South Wales, 2228, Australia

  • Royal Liverpool University Hospital

    Liverpool, L7 8XP, United Kingdom

  • Royal Victoria Infirmary

    Newcastle upon Tyne, NE1 4LP, United Kingdom

  • Samsung Medical Center

    Seoul, 06351, South Korea

  • Seoul National University Bundang Hospital

    Seongnam-si, 13605, South Korea

  • Seoul National University Hospital

    Seoul, 03080, South Korea

  • Singapore Eye Research Institute

    Singapore, 168751, Singapore

  • Stadtspital Triemli Ophthalmologische Klinik

    Zurich, 8063, Switzerland

  • Sunderland Eye Infirmary

    Sunderland, SR2 9HP, United Kingdom

  • Sydney Eye Hospital

    Sydney, New South Wales, 2000, Australia

  • Sydney Retina Clinic and Day Surgery

    Sydney, New South Wales, 2000, Australia

  • Taipei Veterans General Hospital

    Taipei, 11217, Taiwan

  • Tan Tock Seng Hospital

    Singapore, 308433, Singapore

  • Tel Aviv Sourasky MC

    Tel Aviv, 6423906, Israel

  • The Lions Eye Institute

    Nedlands, Western Australia, 6009, Australia

  • UZ Leuven Gasthuisberg

    Leuven, 3000, Belgium

  • Universidade Federal de Sao Paulo - UNIFESPX

    São Paulo, São Paulo, 04023-062, Brazil

  • Universitatsklinikum Bonn

    Bonn, 53127, Germany

  • Universitatsklinikum Hamburg-Eppendorf

    Hamburg, 20246, Germany

  • Universitatsklinikum Koln

    Cologne, 50937, Germany

  • Universitatsklinikum Munster

    Münster, 48149, Germany

  • Universitatsklinikum Tubingen

    Tübingen, 72076, Germany

  • Universitatsklinikum Ulm, Augenklinik und Poliklinik

    Ulm, 89075, Germany

  • Universitatsspital Basel Augenklinik Klinik

    Basel, 4056, Switzerland

  • Universitätsklinikum Freiburg, Klinik für Augenheilkunde

    Freiburg im Breisgau, 79106, Germany

  • Vista Klinik Ophthalmologische Klinik

    Binningen, 4102, Switzerland

  • Yeungnam University Medical Center

    Daegu, 42415, South Korea

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