Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

New eye injection aims to halt blindness from dry AMD in major trial

NCT ID NCT06659445

Disease control Sponsor: ONL Therapeutics 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 11, 2026 · Updated 8 times

Summary

This study tests an experimental drug called ONL1204, given as an eye injection, to see if it can slow the growth of blind spots in people with geographic atrophy, an advanced form of dry age-related macular degeneration. About 324 adults aged 55 and older will receive either the drug or a sham injection. The goal is to preserve vision and prevent further damage to the retina.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 324 people

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

Started

Oct 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

55 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: 1. 55 years of age or older at Screening. 2. Able and willing to give informed consent and attend study visits. 3. Women or intersex individuals must be willing to use 2 forms of effective contraception during the study and for at least 90 days following the last dose of study drug, be postmenopausal for at least 12 months prior to study entry, or surgically sterile. If of childbearing potential, a negative urine pregnancy test is required at Screening and prior to the administration of study drug at each visit. 4. Men or intersex individuals with partners of childbearing potential must be willing to use permissible methods of contraception and refrain from sperm donation during the study and for at least 90 days following the last dose of study drug. 5. If currently using Age-related Eye Disease Study 2 (AREDS, AREDS2, or similar nutraceutical therapy at Screening, patient must be willing to continue use for the duration of the study. If not currently using AREDS2 or similar, patient must be willing to continue not to use therapy for the duration of the study. Patient must agree to choose either approach. Study Eye Inclusion Criteria: 6. BCVA of 24 letters or more using ETDRS charts in the study eye at Screening. 7. Intraocular pressure (IOP) of 22 mmHg or lower in the study eye at Screening. The GA lesion must meet all the following criteria: 8. Non-foveal GA associated with AMD without eMNV in the study eye per Investigator's evaluation and as confirmed by the central RC. 9. GA ≥0.85 disc area (DA) (2.125 mm2) and ≤8.05 DA (20.125 mm2) in the study eye as confirmed by the central RC. 10. If GA in the study eye is multifocal, at least 1 focal lesion must be ≥0.425 DA (1.063 mm2) as confirmed by the central RC. 11. Non-foveal GA (GA lesion up to the fovea, but not subfoveal) with the lesion's closest border 1725 microns or less from the foveal center in the study eye, as confirmed by the central RC. 12. The entire GA lesion in the study eye must be completely visualized on the macula-centered FAF image, must be able to be imaged in its entirety, and must not be contiguous with any areas of peripapillary atrophy per the Investigator's evaluation and as confirmed by the central RC. 13. A pattern of hyper-autofluorescence in the junctional zone of GA in the study eye must be present as confirmed by the central RC. Fellow Eye Inclusion Criterion: 14. BCVA of 19 letters or more using ETDRS charts in the fellow eye at Screening. Exclusion Criteria: 1. Current or planned participation in another investigational clinical study or use of any other investigational drugs or devices at least 6 months prior to enrollment or during the study period without prior written Sponsor approval. 2. Previous ophthalmic disease gene therapy or planned participation in any gene therapy clinical study during the study period. 3. Current or planned use of systemic complement inhibitors during the study period. 4. Any ocular or systemic condition that, in the opinion of the Investigator, makes the patient unsuitable for treatment with an investigational drug or that would compromise the safety or efficacy assessments of the study. 5. Treatment with any ocular or systemic medication that is known to be toxic to the lens, retina, or optic nerve (including, but not limited to, aminoglycosides, vancomycin, hydroxychloroquine, interferon, tacrolimus, cisplatin, bis-chloroethyl nitrosourea, carmustine, ethambutol, and tamoxifen) within 90 days prior to Screening or anticipated during the study period. 6. Any previous treatment of pentosan polysulfate (Elmiron®) is exclusionary. 7. Known allergy to fluorescein, povidone iodine, or any ingredients of the study drug or avacincaptad pegol intravitreal solution. 8. Individuals who are currently pregnant, planning to become pregnant, or are nursing at Screening or during the study period. Study Eye Exclusion Criteria: 9. Active ocular or periocular infection in the study eye. 10. Any contraindication to an IVT injection in the study eye. 11. Any media opacity in the study eye that limits visual acuity, clinical visualization of the retina, or retinal imaging as determined by the Investigator. 12. Previous IVT pharmaceutical treatment in the study eye with any agent except Food and Drug Administration (FDA)-approved complement inhibitors and treatment with FDA-approved complement inhibitors within 12 weeks prior to Screening. 13. Any history of incisional retinal surgery in the study eye including but not limited to scleral buckle or vitrectomy. (Retinal laser for a tear or hole 3 months or more prior to Screening is not exclusionary). 14. History of incisional glaucoma surgery including trabeculectomy, tube shunt, or minimally invasive glaucoma surgery in the study eye. (Glaucoma laser procedures performed at least 6 months prior to Screening are not exclusionary). 15. Yttrium aluminum garnet capsulotomy in the study eye within 1 month prior to Screening. 16. Cataract surgery in the study eye planned or expected during the study period. 17. Aphakia with absence of the posterior capsule in the study eye. (Pseudophakia with an open posterior capsule is not exclusionary). 18. Any current evidence or history in the study eye of exudative ("wet") AMD, including any RPE rips or evidence of actively leaking neovascularization anywhere in the retina based on the FA or SD-OCT as assessed per the Investigator's evaluation and confirmed by the central RC. 19. Any clinically significant retinal disease other than AMD except benign degenerative conditions (eg, Cobblestone degeneration) in the study eye. 20. Intraocular surgery in the study eye (including lens replacement surgery) within 3 months prior to Screening. See Exclusion Criteria 12 and 13 pertaining to retinal and glaucoma surgery, respectively. 21. Previous therapeutic radiation (including transpupillary thermotherapy, photodynamic therapy, or external-beam) in the region of the study eye. Fellow Eye Exclusion Criterion: 22. Planned or expected IVT injection in the fellow eye for treatment of GA with agents other than FDA-approved complement inhibitors (pegcetacoplan or avacincaptad pegol IVT solution \[Izervay™\]) during the study period. Either Eye Exclusion Criteria: 23. Active intraocular inflammation in either eye or a history of uveitis or endophthalmitis in either eye. 24. GA in either eye due to causes other than AMD. 25. Any ophthalmic condition in either eye that is likely to require surgery during the study period.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Age-related macular degeneration (AMD) are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

age-related macular degeneration dry age related macular degeneration Geographic Atrophy macular degeneration

As listed by the trial registrant

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

Age-related macular degeneration (AMD) Geographic atrophy (GA)

How to take part

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

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    120 sites in 12 countries. The list below names each one and where it is.

  3. 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 ↗

  4. 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

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • AIBILI

    RECRUITING

    Coimbra, Portugal, 3000-548, Portugal

  • Associated Retina Consultants

    RECRUITING

    Gilbert, Arizona, 85297, United States

  • Associated Retina Consultants

    RECRUITING

    Phoenix, Arizona, 85020, United States

  • Associated Retinal Consultants, P.C.

    RECRUITING

    Royal Oak, Michigan, 48073, United States

  • Associated Retinal Consultants, P.C.

    RECRUITING

    Traverse City, Michigan, 49686, United States

  • Augen-Zentrum-Nordwest

    RECRUITING

    Ahaus, Germany, 48683, Germany

  • Augenarzt Praxisgemeinschaft Gutblick AG

    RECRUITING

    Bern, Switzerland, 3011, Switzerland

  • Augenarzt Praxisgemeinschaft Gutblick AG

    RECRUITING

    Zurich, Switzerland, 8620, Switzerland

  • Augenzentrum Prof. Dr. Koch GmbH

    RECRUITING

    Frankfurt am Main, Germany, 60549, Germany

  • Austin Retina Associates

    RECRUITING

    Austin, Texas, 78705, United States

  • Axon Clinical, s.r.o.

    RECRUITING

    Prague, Czech Republic, 150 00, Czechia

  • Bay Area Retina Associates

    RECRUITING

    Walnut Creek, California, 94598, United States

  • Bonifraterskie Centrum Medyczne sp. z o.o.

    RECRUITING

    Lodz, Poland, 93-357, Poland

  • Budapest Retina Associates, Opthalmology

    RECRUITING

    Budapest, Hungry, 1133, Hungary

  • Budapesti Bajcsy-Zsilinszky Kórház és Rendelőintézet, Szemészeti Osztály

    RECRUITING

    Budapest, Hungry, 1106, Hungary

  • Budapesti Jahn Ferenc Dél-pesti Kórház és Rendelőintézet, Szemészeti Osztály

    RECRUITING

    Budapest, Hungry, 1204, Hungary

  • California Retina Consultants

    RECRUITING

    Bakersfield, California, 93309, United States

  • Centro de Oftalmología Barraquer

    RECRUITING

    Barcelona, Spain, 08021, Spain

  • Centrum Diagnostyki I Mikrochirurgii Oka Lens sp. Z o.o.

    RECRUITING

    Olsztyn, Poland, 10-424, Poland

  • Centrum Medyczne Dietla 19 sp. z o.o.

    RECRUITING

    Krakow, Poland, 31-070, Poland

  • Charleston Neuroscience Institute

    RECRUITING

    Mt. Pleasant, South Carolina, 29464, United States

  • Cleveland Clinic Foundation-Cole Eye Institute

    RECRUITING

    Cleveland, Ohio, 44195, United States

  • Clinique d'ophtalmologie des Laurentides

    RECRUITING

    Boisbriand, Quebec, J7H0E8, Canada

  • Cumberland Valley Retina Consultants

    RECRUITING

    Hagerstown, Maryland, 21740, United States

  • Debreceni Egyetem Klinikai Központ, Szemklinika

    RECRUITING

    Debrecen, Hungry, 4032, Hungary

  • Desert Retina Consultants

    RECRUITING

    Palm Desert, California, 92211, United States

  • Duke Eye Center

    RECRUITING

    Durham, North Carolina, 27710, United States

  • Erie Retina Research, LLC (Clinic)

    RECRUITING

    Erie, Pennsylvania, 16505, United States

  • Fakultni nemocnice Kralovske Vinohrady

    RECRUITING

    Prague, Czech Republic, 100 34, Czechia

  • Florida Retina Institute

    RECRUITING

    Orlando, Florida, 32806, United States

  • Fundación de Oftalmologia Medica de la Comunitat Valenciana (FOM)

    RECRUITING

    Valencia, Spain, 46015, Spain

  • General Hospital of Athens "G. Gennimatas", 1st University Eye Clinic

    RECRUITING

    Athens, Greece, 11527, Greece

  • Gloucestershire Hospitals NHS Foundation Trust

    RECRUITING

    Gloucester, England, GL1 3NN, United Kingdom

  • Hospital Arruzafa

    RECRUITING

    Córdoba, Spain, 14012, Spain

  • Hospital Ophthalmic Jules-Gonin Foundation

    RECRUITING

    Lausanne, Switzerland, 1001, Switzerland

  • Hospital Universitario Miguel Servet

    RECRUITING

    Zaragoza, Spain, 50009, Spain

  • Hospital Universitario Puerta de Hierro Majadahonda

    RECRUITING

    Madrid, Spain, 28222, Spain

  • Hospital Universitario Virgen Macarena

    RECRUITING

    Seville, Spain, 41009, Spain

  • Hull University Teaching Hospitals NHS Trust, Hull Royal Infirmary

    RECRUITING

    York, England, HU3 2JZ, United Kingdom

  • Illinois Retina Associates, S.C.

    RECRUITING

    Oak Park, Illinois, 60304, United States

  • Institut Catalâ de Retina

    RECRUITING

    Barcelona, Spain, 08022, Spain

  • Instituto Clinico Quirurgico de Oftalmologia (ICQO)

    RECRUITING

    Bilbao, Spain, 48010, Spain

  • Internationale Innovative Ophthalmochirurgie GbR c/o MVZ Breyer Kaymak Klabe Augenchirurgie

    RECRUITING

    Düsseldorf, Germany, 40549, Germany

  • King's College Hospital NHS Foundation Trust

    RECRUITING

    London, England, SE5 9RS, United Kingdom

  • Klinika Okulistyczna Jasne Blonia sp. z o.o

    RECRUITING

    Lodz, Poland, 91-134, Poland

  • Konventhospital der Barmherzigen Brüder Linz Abteilung für Augenheilkunde

    RECRUITING

    Linz, Austria, 4020, Austria

  • Long Island Vitreoretinal Consultants

    RECRUITING

    Westbury, New York, 11590, United States

  • Macula and Retina Institute

    RECRUITING

    Glendale, California, 91203, United States

  • Mayo Clinic

    RECRUITING

    Rochester, Minnesota, 55905, United States

  • Medical Center Ophthalmology Associates, LLP

    RECRUITING

    San Antonio, Texas, 78240, United States

  • Medizinische Universität Wien

    RECRUITING

    Vienna, Austria, 1090, Austria

  • NEMOS Medical Private Care s.r.o.

    RECRUITING

    Sokolov, Czech Republic, 356 01, Czechia

  • Newcastle Upon Tyne NHS Foundation Trust

    RECRUITING

    Newcastle, England, NE1 4LP, United Kingdom

  • North Carolina Retina Associates

    RECRUITING

    Cary, North Carolina, 27511, United States

  • North Carolina Retina Associates

    RECRUITING

    Greenville, North Carolina, 27834, United States

  • North Carolina Retina Associates, S.C.

    RECRUITING

    Wake Forest, North Carolina, 27587, United States

  • Northwestern Medical Group

    RECRUITING

    Chicago, Illinois, 60611, United States

  • Oculomedica Sp. z o.o.

    RECRUITING

    Bydgoszcz, Poland, 85-157, Poland

  • Ophthalmic Consultants of Long Island

    RECRUITING

    Oceanside, New York, 11572, United States

  • Optimum Profesorskie Centrum Okulistyki sp. z o.o.

    RECRUITING

    Gdansk, Poland, 80-180, Poland

  • Pacific Northwest Retina

    RECRUITING

    Bellevue, Washington, 98004, United States

  • Pacific Northwest Retina, PLLC

    RECRUITING

    Silverdale, Washington, 98383, United States

  • Palmetto Retina Center

    RECRUITING

    West Columbia, South Carolina, 29169, United States

  • Philipps-Universität Marburg

    RECRUITING

    Marburg, Germany, 35043, Germany

  • Piedmont Eye Center

    RECRUITING

    Lynchburg, Virginia, 24502, United States

  • Pécsi Tudományegyetem Klinikai Kozpont, Szemeszeti Klinika

    RECRUITING

    Pécs, Hungry, 7623, Hungary

  • Retina Associates of Florida, LLC

    RECRUITING

    Tampa, Florida, 33609-4614, United States

  • Retina Associates of South Texas, PA

    RECRUITING

    San Antonio, Texas, 78240, United States

  • Retina Associates of Western NY

    RECRUITING

    Rochester, New York, 14620, United States

  • Retina Associates, Ltd.

    RECRUITING

    Elmhurst, Illinois, 60126, United States

  • Retina Center of Texas

    RECRUITING

    Southlake, Texas, 76092, United States

  • Retina Consultants of Southern Colorado

    RECRUITING

    Colorado Springs, Colorado, 80909-1183, United States

  • Retina Consultants of Texas

    RECRUITING

    Beaumont, Texas, 77707, United States

  • Retina Consultants of Texas

    RECRUITING

    Bellaire, Texas, 77401, United States

  • Retina Consultants of Texas

    RECRUITING

    Katy, Texas, 77494, United States

  • Retina Consultants of Texas

    RECRUITING

    San Antonio, Texas, 78240, United States

  • Retina Consultants of Texas

    RECRUITING

    The Woodlands, Texas, 77384, United States

  • Retina Group of Florida

    RECRUITING

    Sarasota, Florida, 34232, United States

  • Retina Group of New England

    RECRUITING

    Waterford, Connecticut, 06385, United States

  • Retina Partners Midwest, P.C.

    RECRUITING

    Carmel, Indiana, 46032, United States

  • Retina Research Institute at New England Retina Consultants

    RECRUITING

    Springfield, Massachusetts, 01107, United States

  • Retina Specialists

    RECRUITING

    Towson, Maryland, 21204, United States

  • Retina Specialty Institute

    RECRUITING

    Pensacola, Florida, 32503, United States

  • Retina Vitreous Surgeons of CNY, PC

    RECRUITING

    Liverpool, New York, 13088, United States

  • Retina-Vitreous Associates Medical Group

    RECRUITING

    Beverly Hills, California, 90211, United States

  • Retinal Consultants Medical Group

    RECRUITING

    Sacramento, California, 95841, United States

  • Royal Victoria Hospital (Ophthalmology Research Suite, EODU)

    RECRUITING

    Belfast, Ireland, BT12 6BA, United Kingdom

  • Salehi Retina Institute, dba Retina Associates of Southern California

    RECRUITING

    Huntington Beach, California, 92647, United States

  • Semmelweis Egyetem, Szemészeti Klinika Kutatóközpont

    RECRUITING

    Budapest, Hungry, 1085, Hungary

  • Sierra Eye Associates

    RECRUITING

    Reno, Nevada, 89502, United States

  • St. Joseph's Health Care London - Ivey Eye Institute

    RECRUITING

    London, Ontario, N6A4V2, Canada

  • Stadtspital Zurich Triemli, Augenklinik, Forschungszentrum, 2K.14

    RECRUITING

    Zurich, Switzerland, 8063, Switzerland

  • Sunderland Eye Infirmary

    RECRUITING

    Sunderland, England, SR2 9HP, United Kingdom

  • Swiss Visio Retina Research Center

    RECRUITING

    Lausanne, Switzerland, 1006, Switzerland

  • Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ, Szemészeti Klinika

    RECRUITING

    Szeged, Hungry, 6720, Hungary

  • Szpital Św. Róży sp. z o. o. sp. k.

    RECRUITING

    Krakow, Poland, 30-394, Poland

  • The Retina Clinic

    RECRUITING

    London, England, W1G 9X, United Kingdom

  • The Retina Group of Washington

    RECRUITING

    Chevy Chase, Maryland, 20815, United States

  • The Retina Institute

    RECRUITING

    St Louis, Missouri, 63128, United States

  • The University of Chicago Medicine Duchossois Center for Advanced Medicine

    RECRUITING

    Chicago, Illinois, 60637, United States

  • Toronto Retina Institute

    RECRUITING

    Toronto, Ontario, M3C0G9, Canada

  • Toronto Western Hospital, University Health Network

    RECRUITING

    Toronto, Ontario, M5T 2S8, Canada

  • Unidade Local De Saude De Santo Antonio

    RECRUITING

    Porto, Portugal, 4050-011, Portugal

  • Unidade Local de Saude de Gaia/Espinho

    RECRUITING

    Gaia, Portugal, 4434-502, Portugal

  • Unidade Local de Saúde de Coimbra

    RECRUITING

    Coimbra, Portugal, 3004-561, Portugal

  • Uniklinikum Würzburg

    RECRUITING

    Würzburg, Germany, 97080, Germany

  • University General Hospital "Attikon", 2nd Department of Ophthalmology, University of Athens

    RECRUITING

    Athens, Greece, 12462, Greece

  • University General Hospital of Heraklion

    RECRUITING

    Heraklion, Greece, 70013, Greece

  • University General Hospital of Ioannina, Ophthalmology Clinica

    RECRUITING

    Ioannina, Greece, 45500, Greece

  • University General Hospital of Patras, Department of Ophthalmology

    RECRUITING

    Pátrai, Greece, 26504, Greece

  • University Hospital Southampton NHS Foundation Trust

    RECRUITING

    Southampton, England, SO16 6YD, United Kingdom

  • University of Michigan Kellogg Eye Center

    RECRUITING

    Ann Arbor, Michigan, 48105, United States

  • Universitäts-Augenklinik Bonn

    RECRUITING

    Bonn, Germany, 53127, Germany

  • VFN Praha

    RECRUITING

    Prague, Czech Republic, 128 08, Czechia

  • VISUS spol. s.r.o.

    RECRUITING

    Náchod, Czech Republic, 574 01, Czechia

  • Valley Retina Institute, P.A.

    RECRUITING

    McAllen, Texas, 78503, United States

  • Vanderbilt Eye Institute

    RECRUITING

    Nashville, Tennessee, 37232, United States

  • Vienna Institute for Research in Ocular Surgery - A Karl-Landsteiner-Institute

    RECRUITING

    Vienna, Austria, 1140, Austria

  • Vista Augenklinik Binningen

    RECRUITING

    Binningen, Switzerland, 4102, Switzerland

  • Észak-Pesti Centrumkórház-Honvédkórház, Szemészeti Osztály

    RECRUITING

    Budapest, Hungry, 1062, Hungary

More trials for these conditions

Other studies related to the condition(s) this trial covers.