AzTrials
AzTrials

Geographic Atrophy (GA)Phase 2NCT06659445

Study to Evaluate Efficacy and Safety of ONL1204 in Patients With GA Associated With AMD

A Phase 2 study testing ONL1204 Opthalmic solution and Avacincaptad Pegol intravitreal solution in people with Geographic Atrophy (GA) and Age - Related Macular Degeneration (AMD), run by ONL Therapeutics at 120 sites in 12 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The purpose of this study is to collect efficacy and safety information of intravitreal injection for 3 experimental arms, including 2 dose levels of ONL1204 and 2 treatment frequencies in patients with GA associated with AMD. Read more about this study

Who is it for?
Ages 55 years and older
What is being tested?
ONL1204 Opthalmic solution and Avacincaptad Pegol intravitreal solution
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
324 participants
Where
120 sitesin 12 countries
Study dates
28 Oct 2025to Nov 2028
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 55 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 55 years of age or older at Screening.
  • Able and willing to give informed consent and attend study visits.
  • 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.
  • 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.
  • 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:
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  • BCVA of 24 letters or more using ETDRS charts in the study eye at Screening.
  • Intraocular pressure (IOP) of 22 mmHg or lower in the study eye at Screening.
  • The GA lesion must meet all the following criteria:
  • Non-foveal GA associated with AMD without eMNV in the study eye per Investigator's evaluation and as confirmed by the central RC.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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:
  • BCVA of 19 letters or more using ETDRS charts in the fellow eye at Screening.

Who cannot join

  • 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.
  • Previous ophthalmic disease gene therapy or planned participation in any gene therapy clinical study during the study period.
  • Current or planned use of systemic complement inhibitors during the study period.
  • 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.
  • 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.
  • Any previous treatment of pentosan polysulfate (Elmiron®) is exclusionary.
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  • Known allergy to fluorescein, povidone iodine, or any ingredients of the study drug or avacincaptad pegol intravitreal solution.
  • Individuals who are currently pregnant, planning to become pregnant, or are nursing at Screening or during the study period.
  • Study Eye Exclusion Criteria:
  • Active ocular or periocular infection in the study eye.
  • Any contraindication to an IVT injection in the study eye.
  • Any media opacity in the study eye that limits visual acuity, clinical visualization of the retina, or retinal imaging as determined by the Investigator.
  • 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.
  • 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).
  • 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).
  • Yttrium aluminum garnet capsulotomy in the study eye within 1 month prior to Screening.
  • Cataract surgery in the study eye planned or expected during the study period.
  • Aphakia with absence of the posterior capsule in the study eye. (Pseudophakia with an open posterior capsule is not exclusionary).
  • 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.
  • Any clinically significant retinal disease other than AMD except benign degenerative conditions (eg, Cobblestone degeneration) in the study eye.
  • 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.
  • Previous therapeutic radiation (including transpupillary thermotherapy, photodynamic therapy, or external-beam) in the region of the study eye.
  • Fellow Eye Exclusion Criterion:
  • 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:
  • Active intraocular inflammation in either eye or a history of uveitis or endophthalmitis in either eye.
  • GA in either eye due to causes other than AMD.
  • Any ophthalmic condition in either eye that is likely to require surgery during the study period.

Trial locations and contacts

120 sites in 12 countries. Contact the study team or a site near you to ask about taking part.

Study Coordinator contact

734-412-8787

info@onltherapeutics.com

120 sites in 12 countries

United States56 sites, 56 recruiting

  • University of Michigan Kellogg Eye Center

    Ann Arbor, Michigan, 48105

    Study Coordinator

    Recruiting

  • Austin Retina Associates

    Austin, Texas, 78705

    Study Coordinator

    Recruiting

  • California Retina Consultants

    Bakersfield, California, 93309

    Study Coordinator

    Recruiting

  • Retina Consultants of Texas

    Beaumont, Texas, 77707

    Study Coordinator

    Recruiting

  • Retina Consultants of Texas

    Bellaire, Texas, 77401

    Study Coordinator

    Recruiting

  • Pacific Northwest Retina

    Bellevue, Washington, 98004

    Study Coordinator

    Recruiting

  • Retina-Vitreous Associates Medical Group

    Beverly Hills, California, 90211

    Study Coordinator

    Recruiting

  • Retina Partners Midwest, P.C.

    Carmel, Indiana, 46032

    Study Coordinator

    Recruiting

  • North Carolina Retina Associates

    Cary, North Carolina, 27511

    Study Coordinator

    Recruiting

  • The Retina Group of Washington

    Chevy Chase, Maryland, 20815

    Study Coordinator

    Recruiting

  • Northwestern Medical Group

    Chicago, Illinois, 60611

    Study Coordinator

    Recruiting

  • The University of Chicago Medicine Duchossois Center for Advanced Medicine

    Chicago, Illinois, 60637

    Study Coordinator

    Recruiting

  • Cleveland Clinic Foundation-Cole Eye Institute

    Cleveland, Ohio, 44195

    Study Coordinator

    Recruiting

  • Retina Consultants of Southern Colorado

    Colorado Springs, Colorado, 80909-1183

    Study Coordinator

    Recruiting

  • Duke Eye Center

    Durham, North Carolina, 27710

    Study Coordinator

    Recruiting

  • Retina Associates, Ltd.

    Elmhurst, Illinois, 60126

    Study Coordinator

    Recruiting

  • Erie Retina Research, LLC (Clinic)

    Erie, Pennsylvania, 16505

    Study Coordinator

    Recruiting

  • Associated Retina Consultants

    Gilbert, Arizona, 85297

    Study Coordinator

    Recruiting

  • Macula and Retina Institute

    Glendale, California, 91203

    Study Coordinator

    Recruiting

  • North Carolina Retina Associates

    Greenville, North Carolina, 27834

    Study Coordinator

    Recruiting

  • Cumberland Valley Retina Consultants

    Hagerstown, Maryland, 21740

    Study Coordinator

    Recruiting

  • Salehi Retina Institute, dba Retina Associates of Southern California

    Huntington Beach, California, 92647

    Study Coordinator

    Recruiting

  • Retina Consultants of Texas

    Katy, Texas, 77494

    Study Coordinator

    Recruiting

  • Retina Vitreous Surgeons of CNY, PC

    Liverpool, New York, 13088

    Study Coordinator

    Recruiting

  • Piedmont Eye Center

    Lynchburg, Virginia, 24502

    Study Coordinator

    Recruiting

  • Valley Retina Institute, P.A.

    McAllen, Texas, 78503

    Study Coordinator

    Recruiting

  • Charleston Neuroscience Institute

    Mt. Pleasant, South Carolina, 29464

    Study Coordinator

    Recruiting

  • Vanderbilt Eye Institute

    Nashville, Tennessee, 37232

    Study Coordinator

    Recruiting

  • Illinois Retina Associates, S.C.

    Oak Park, Illinois, 60304

    Study Coordinator

    Recruiting

  • Ophthalmic Consultants of Long Island

    Oceanside, New York, 11572

    Study Coordinator

    Recruiting

  • Florida Retina Institute

    Orlando, Florida, 32806

    Study Coordinator

    Recruiting

  • Desert Retina Consultants

    Palm Desert, California, 92211

    Study Coordinator

    Recruiting

  • Retina Specialty Institute

    Pensacola, Florida, 32503

    Study Coordinator

    Recruiting

  • Associated Retina Consultants

    Phoenix, Arizona, 85020

    Study Coordinator

    Recruiting

  • Sierra Eye Associates

    Reno, Nevada, 89502

    Study Coordinator

    Recruiting

  • Mayo Clinic

    Rochester, Minnesota, 55905

    Study Coordinator

    Recruiting

  • Retina Associates of Western NY

    Rochester, New York, 14620

    Study Coordinator

    Recruiting

  • Associated Retinal Consultants, P.C.

    Royal Oak, Michigan, 48073

    Study Coordinator

    Recruiting

  • Retinal Consultants Medical Group

    Sacramento, California, 95841

    Study Coordinator

    Recruiting

  • Medical Center Ophthalmology Associates, LLP

    San Antonio, Texas, 78240

    Study Coordinator

    Recruiting

  • Retina Associates of South Texas, PA

    San Antonio, Texas, 78240

    Study Coordinator

    Recruiting

  • Retina Consultants of Texas

    San Antonio, Texas, 78240

    Study Coordinator

    Recruiting

  • Retina Group of Florida

    Sarasota, Florida, 34232

    Study Coordinator

    Recruiting

  • Pacific Northwest Retina, PLLC

    Silverdale, Washington, 98383

    Study Coordinator

    Recruiting

  • Retina Center of Texas

    Southlake, Texas, 76092

    Study Coordinator

    Recruiting

  • Retina Research Institute at New England Retina Consultants

    Springfield, Massachusetts, 01107

    Study Coordinator

    Recruiting

  • The Retina Institute

    St Louis, Missouri, 63128

    Study Coordinator

    Recruiting

  • Retina Associates of Florida, LLC

    Tampa, Florida, 33609-4614

    Study Coordinator

    Recruiting

  • Retina Consultants of Texas

    The Woodlands, Texas, 77384

    Study Coordinator

    Recruiting

  • Retina Specialists

    Towson, Maryland, 21204

    Study Coordinator

    Recruiting

  • Associated Retinal Consultants, P.C.

    Traverse City, Michigan, 49686

    Study Coordinator

    Recruiting

  • North Carolina Retina Associates, S.C.

    Wake Forest, North Carolina, 27587

    Study Coordinator

    Recruiting

  • Bay Area Retina Associates

    Walnut Creek, California, 94598

    Study Coordinator

    Recruiting

  • Retina Group of New England

    Waterford, Connecticut, 06385

    Study Coordinator

    Recruiting

  • Palmetto Retina Center

    West Columbia, South Carolina, 29169

    Study Coordinator

    Recruiting

  • Long Island Vitreoretinal Consultants

    Westbury, New York, 11590

    Study Coordinator

    Recruiting

Other trials in United States

Hungary8 sites, 8 recruiting

  • Észak-Pesti Centrumkórház-Honvédkórház, Szemészeti Osztály

    Budapest, Hungry, 1062

    Study Coordinator

    Recruiting

  • Semmelweis Egyetem, Szemészeti Klinika Kutatóközpont

    Budapest, Hungry, 1085

    Study Coordinator

    Recruiting

  • Budapesti Bajcsy-Zsilinszky Kórház és Rendelőintézet, Szemészeti Osztály

    Budapest, Hungry, 1106

    Study Coordinator

    Recruiting

  • Budapest Retina Associates, Opthalmology

    Budapest, Hungry, 1133

    Study Coordinator

    Recruiting

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

    Budapest, Hungry, 1204

    Study Coordinator

    Recruiting

  • Debreceni Egyetem Klinikai Központ, Szemklinika

    Debrecen, Hungry, 4032

    Study Coordinator

    Recruiting

  • Pécsi Tudományegyetem Klinikai Kozpont, Szemeszeti Klinika

    Pécs, Hungry, 7623

    Study Coordinator

    Recruiting

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

    Szeged, Hungry, 6720

    Study Coordinator

    Recruiting

Other trials in Hungary

Spain8 sites, 8 recruiting

  • Centro de Oftalmología Barraquer

    Barcelona, Spain, 08021

    Study Coordinator

    Recruiting

  • Institut Catalâ de Retina

    Barcelona, Spain, 08022

    Study Coordinator

    Recruiting

  • Instituto Clinico Quirurgico de Oftalmologia (ICQO)

    Bilbao, Spain, 48010

    Study Coordinator

    Recruiting

  • Hospital Arruzafa

    Córdoba, Spain, 14012

    Study Coordinator

    Recruiting

  • Hospital Universitario Puerta de Hierro Majadahonda

    Madrid, Spain, 28222

    Study Coordinator

    Recruiting

  • Hospital Universitario Virgen Macarena

    Seville, Spain, 41009

    Study Coordinator

    Recruiting

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

    Valencia, Spain, 46015

    Study Coordinator

    Recruiting

  • Hospital Universitario Miguel Servet

    Zaragoza, Spain, 50009

    Study Coordinator

    Recruiting

Other trials in Spain

United Kingdom8 sites, 8 recruiting

  • Royal Victoria Hospital (Ophthalmology Research Suite, EODU)

    Belfast, Ireland, BT12 6BA

    Study Coordinator

    Recruiting

  • Gloucestershire Hospitals NHS Foundation Trust

    Gloucester, England, GL1 3NN

    Study Coordinator

    Recruiting

  • King's College Hospital NHS Foundation Trust

    London, England, SE5 9RS

    Study Coordinator

    Recruiting

  • The Retina Clinic

    London, England, W1G 9X

    Study Coordinator

    Recruiting

  • Newcastle Upon Tyne NHS Foundation Trust

    Newcastle, England, NE1 4LP

    Study Coordinator

    Recruiting

  • University Hospital Southampton NHS Foundation Trust

    Southampton, England, SO16 6YD

    Study Coordinator

    Recruiting

  • Sunderland Eye Infirmary

    Sunderland, England, SR2 9HP

    Study Coordinator

    Recruiting

  • Hull University Teaching Hospitals NHS Trust, Hull Royal Infirmary

    York, England, HU3 2JZ

    Study Coordinator

    Recruiting

Other trials in United Kingdom

Poland7 sites, 7 recruiting

  • Oculomedica Sp. z o.o.

    Bydgoszcz, Poland, 85-157

    Study Coordinator

    Recruiting

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

    Gdansk, Poland, 80-180

    Study Coordinator

    Recruiting

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

    Krakow, Poland, 30-394

    Study Coordinator

    Recruiting

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

    Krakow, Poland, 31-070

    Study Coordinator

    Recruiting

  • Klinika Okulistyczna Jasne Blonia sp. z o.o

    Lodz, Poland, 91-134

    Study Coordinator

    Recruiting

  • Bonifraterskie Centrum Medyczne sp. z o.o.

    Lodz, Poland, 93-357

    Study Coordinator

    Recruiting

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

    Olsztyn, Poland, 10-424

    Study Coordinator

    Recruiting

Other trials in Poland

Germany6 sites, 6 recruiting

  • Augen-Zentrum-Nordwest

    Ahaus, Germany, 48683

    Study Coordinator

    Recruiting

  • Universitäts-Augenklinik Bonn

    Bonn, Germany, 53127

    Study Coordinator

    Recruiting

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

    Düsseldorf, Germany, 40549

    Study Coordinator

    Recruiting

  • Augenzentrum Prof. Dr. Koch GmbH

    Frankfurt am Main, Germany, 60549

    Study Coordinator

    Recruiting

  • Philipps-Universität Marburg

    Marburg, Germany, 35043

    Study Coordinator

    Recruiting

  • Uniklinikum Würzburg

    Würzburg, Germany, 97080

    Study Coordinator

    Recruiting

Other trials in Germany

Switzerland6 sites, 6 recruiting

  • Augenarzt Praxisgemeinschaft Gutblick AG

    Bern, Switzerland, 3011

    Study Coordinator

    Recruiting

  • Vista Augenklinik Binningen

    Binningen, Switzerland, 4102

    Study Coordinator

    Recruiting

  • Hospital Ophthalmic Jules-Gonin Foundation

    Lausanne, Switzerland, 1001

    Study Coordinator

    Recruiting

  • Swiss Visio Retina Research Center

    Lausanne, Switzerland, 1006

    Study Coordinator

    Recruiting

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

    Zurich, Switzerland, 8063

    Study Coordinator

    Recruiting

  • Augenarzt Praxisgemeinschaft Gutblick AG

    Zurich, Switzerland, 8620

    Study Coordinator

    Recruiting

Other trials in Switzerland

Czechia5 sites, 5 recruiting

  • VISUS spol. s.r.o.

    Náchod, Czech Republic, 574 01

    Study Coordinator

    Recruiting

  • Fakultni nemocnice Kralovske Vinohrady

    Prague, Czech Republic, 100 34

    Study Coordinator

    Recruiting

  • VFN Praha

    Prague, Czech Republic, 128 08

    Study Coordinator

    Recruiting

  • Axon Clinical, s.r.o.

    Prague, Czech Republic, 150 00

    Study Coordinator

    Recruiting

  • NEMOS Medical Private Care s.r.o.

    Sokolov, Czech Republic, 356 01

    Study Coordinator

    Recruiting

Other trials in Czechia

Greece5 sites, 5 recruiting

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

    Athens, Greece, 11527

    Study Coordinator

    Recruiting

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

    Athens, Greece, 12462

    Study Coordinator

    Recruiting

  • University General Hospital of Heraklion

    Heraklion, Greece, 70013

    Study Coordinator

    Recruiting

  • University General Hospital of Ioannina, Ophthalmology Clinica

    Ioannina, Greece, 45500

    Study Coordinator

    Recruiting

  • University General Hospital of Patras, Department of Ophthalmology

    Pátrai, Greece, 26504

    Study Coordinator

    Recruiting

Other trials in Greece

Canada4 sites, 4 recruiting

  • Clinique d'ophtalmologie des Laurentides

    Boisbriand, Quebec, J7H0E8

    Study Coordinator

    Recruiting

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

    London, Ontario, N6A4V2

    Study Coordinator

    Recruiting

  • Toronto Retina Institute

    Toronto, Ontario, M3C0G9

    Study Coordinator

    Recruiting

  • Toronto Western Hospital, University Health Network

    Toronto, Ontario, M5T 2S8

    Study Coordinator

    Recruiting

Other trials in Canada

Portugal4 sites, 4 recruiting

  • AIBILI

    Coimbra, Portugal, 3000-548

    Study Coordinator

    Recruiting

  • Unidade Local de Saúde de Coimbra

    Coimbra, Portugal, 3004-561

    Study Coordinator

    Recruiting

  • Unidade Local de Saude de Gaia/Espinho

    Gaia, Portugal, 4434-502

    Study Coordinator

    Recruiting

  • Unidade Local De Saude De Santo Antonio

    Porto, Portugal, 4050-011

    Study Coordinator

    Recruiting

Other trials in Portugal

Austria3 sites, 3 recruiting

  • Konventhospital der Barmherzigen Brüder Linz Abteilung für Augenheilkunde

    Linz, Austria, 4020

    Study Coordinator

    Recruiting

  • Medizinische Universität Wien

    Vienna, Austria, 1090

    Study Coordinator

    Recruiting

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

    Vienna, Austria, 1140

    Study Coordinator

    Recruiting

Other trials in Austria

About this study

Official title: A Phase 2 Multicenter, Randomized, Double-masked, Sham-controlled, Reference-arm Study to Evaluate Efficacy and Safety of ONL1204 in Patients With Geographic Atrophy (GA) Associated With Age-related Macular Degeneration (AMD)

The purpose of this study is to collect efficacy and safety information of intravitreal injection for 3 experimental arms, including 2 dose levels of ONL1204 and 2 treatment frequencies in patients with GA associated with AMD.

GA associated with AMD is one of the world's leading causes of visual disability and legal blindness globally. Associated with aging, cigarette smoking, obesity, diets low in certain nutrients, a lifestyle related to cardiac risk, and a growing list of genetic factors, AMD is becoming an increasingly prevalent public health concern, especially as the global population ages. ONL1204 is a first-in-class inhibitor of fragment apoptosis stimulator receptor-mediated cell death that has demonstrated protection of multiple retinal cell types in numerous preclinical models of retinal disease, including models of dry AMD.

Being tested
ONL1204 Opthalmic solution, Avacincaptad Pegol intravitreal solution, Sham
Keywords
Phase 2, ONL1204, Geographic Atrophy (GA), Age-related Macular Degeneration (AMD)
Medical subject headings
Geographic Atrophy, Macular Degeneration

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ONL1204 Opthalmic solutionDrug

    Liquid formulation ONL1204 Ophthalmic Solution administered by intravitreal (IVT) injection

  • Avacincaptad Pegol intravitreal solutionDrug

    Liquid formulation Avacincaptad Pegol administered by intravitreal (IVT) injection

  • ShamOther

    Sham injection

Study groups in NCT06659445
Study groupRoleWhat they receive
ONL1204 Opthalmic solution (1 of 6 Treatment Groups) administered by intravitreal injectionActive comparatorONL1204 100 µg administered by intravitreal (IVT) injection every 12 weeks
Receives: Drug: ONL1204 Opthalmic solution
ONL1204 Opthalmic solution (2 of 6 Treatment Groups) administered by intravitreal injectionActive comparatorONL1204 200 µg administered by intravitreal (IVT) injection every 12 weeks
Receives: Drug: ONL1204 Opthalmic solution
ONL1204 Opthalmic solution (3 of 6 Treatment Groups) administered by intravitreal injectionExperimentalONL1204 200 µg administered by intravitreal (IVT) injection every 24 weeks
Receives: Drug: ONL1204 Opthalmic solution
Sham Comparator (4 of 6 Treatment Groups)Sham comparatorSham injection every 12 weeks
Receives: Other: Sham
Sham Comparator (5 of 6 Treatment Groups)Sham comparatorSham injection every 24 weeks
Receives: Other: Sham
Avacincaptad pegol intravitreal solution (6 of 6 Treatment Groups - US ONLY)Active comparatorAvacincaptad pegol administered by intravitreal (IVT) injection - (2 mg (0.1 mL of 20 mg/mL solution) once monthly
Receives: Drug: Avacincaptad Pegol intravitreal solution

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Primary Endpoint

    GA lesion area

    Measured: From enrollment to the end of treatment at 48 weeks.

Secondary outcomes (2)

  1. Secondary Endpoints (Safety)

    Incidence of new active exudative macular neovascularization (eMNV) in the study eye

    Measured: From enrollment to the end of treatment at 48 weeks.

  2. Secondary Endpoints (Safety)

    Incidence of Early Treatment of Diabetic Retinopathy Study (ETDRS) best corrected visual acuity (BCVA) loss

    Measured: From enrollment to the end of treatment at 48 weeks.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Oct 2024
  2. Study start28 Oct 2025
  3. Primary completionNov 2028 (estimated)
  4. Study completionNov 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
324 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06659445
Sponsor's protocol ID
ONL1204-GA-002
Status last verified
Sep 2026
First submitted
23 Oct 2024
Last updated
10 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing ONL1204 Opthalmic solution and Avacincaptad Pegol intravitreal solution in people with Geographic Atrophy (GA) and Age - Related Macular Degeneration (AMD), run by ONL Therapeutics at 120 sites in 12 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 120 sites in United States, Hungary, Spain, United Kingdom, Poland and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Study Coordinator (734-412-8787, info@onltherapeutics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Primary Endpoint (time frame: From enrollment to the end of treatment at 48 weeks.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06659445.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2026.

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