Study of ONL1204 eye injections to slow vision loss in patients with age-related macular degeneration and geographic atrophy

1

What is this study about?

This study focuses on patients with Geographic Atrophy, a severe form of Age-related Macular Degeneration (AMD). AMD is an eye condition that causes progressive damage to the central part of the retina, leading to vision loss in the center of the field of vision. Geographic Atrophy is the advanced form of dry AMD, where patches of retinal tissue gradually deteriorate.

The study will test a new medication called ONL1204, which is given as an injection directly into the eye (intravitreal injection). Some participants will receive ONL1204, while others will receive a sham injection. The purpose is to determine if ONL1204 can slow down the progression of Geographic Atrophy in people with AMD.

During the study, participants will receive multiple eye injections over a period of 60 days. The total amount of medication given will not exceed 1200 micrograms. Throughout the study, doctors will monitor changes in the areas of retinal damage to assess how well the treatment is working.

1 Initial screening

Your eligibility for the study will be evaluated based on the following criteria:

You must be 55 years or older

You must have non-foveal geographic atrophy (a specific type of age-related macular degeneration) in the study eye

Your vision must meet specific requirements: at least 24 letters on the vision test chart for the study eye, and at least 19 letters for the other eye

2 Treatment assignment

You will be randomly assigned to receive either:

ONL1204 Ophthalmic Solution – a medication given as an eye injection

or

Sham injection – a procedure that simulates an injection but does not deliver actual medication

3 Treatment administration

The treatment will be given through intravitreal injection (an injection into the eye)

If you are currently taking eye supplements (AREDS2 or similar), you will continue taking them throughout the study

If you are not taking these supplements, you will continue without them during the study

4 Study duration

The study is expected to run from June 2025 to January 2028

During this period, your eye condition will be monitored to assess how the area of geographic atrophy changes

Who Can Join the Study?

  • Must be 55 years of age or older at the time of screening
  • If currently taking AREDS2 supplements (special eye health vitamins), must agree to continue taking them throughout the study. If not taking them, must agree not to start during the study
  • Must have non-foveal geographic atrophy (an advanced form of age-related macular degeneration that does not affect the center of vision) in the study eye, without evidence of exudative macular neovascularization (abnormal blood vessel growth)
  • Must have a Best Corrected Visual Acuity (BCVA) of at least 24 letters when tested using special eye charts (ETDRS charts) in the eye being studied
  • Must have a Best Corrected Visual Acuity (BCVA) of at least 19 letters when tested using special eye charts (ETDRS charts) in the other eye
  • Both men and women may participate in the study

Who Cannot Join the Study?

  • History of any eye surgery (except cataract surgery) within 3 months before starting the study
  • Active eye infection or inflammation
  • Presence of other serious eye conditions that could affect vision
  • Previous participation in other clinical trials within 30 days
  • Known allergies to medications similar to the study drug
  • Uncontrolled high blood pressure (blood pressure consistently above normal levels despite treatment)
  • Pregnancy or planning to become pregnant during the study period
  • History of stroke (sudden loss of brain function due to blocked or ruptured blood vessels) within the past 6 months
  • Active or recent cancer treatment within the past 3 months
  • Severe health conditions that could interfere with study participation
  • Unable to provide informed consent or follow study procedures
  • Current drug or alcohol abuse
  • Taking medications that could interact with the study drug
  • Any condition that the study doctor believes would make participation unsafe

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Other Sites

Site Name City Country Status
Central Hospital Of Northern Pest Military Hospital Budapest Hungary
ASST Fatebenefratelli Sacco Milan Italy
Universitaetsklinikum Aachen AöR Aachen Germany
Hospital Universitario Puerta De Hierro De Majadahonda Majadahonda Spain
Unidade Local De Saude De Gaia/Espinho E.P.E. Vila Nova De Gaia Portugal
University General Hospital Of Heraklion Heraklion Greece
Clinica De Oftalmologia De Cordoba S.L. Cordoba Spain
Centro De Oftalmologia Barraquer S.A. Barcelona Spain
Institut Catala De Retina S.L. Barcelona Spain
Association For Innovation And Biomedical Research On Light And Image Coimbra Portugal
Centrum Diagnostyki I Mikrochirurgii Oka Lens Sp. z o.o. Olsztyn Poland
Bonifraterskie Centrum Medyczne Sp. z o.o. Lodz Poland
Institut Fuer Forschung Und Innovation In Der Augenchirurgie Vienna Austria
University Of Debrecen Debrecen Hungary
Hospital Unviersitario Miguel Servet Zaragoza Spain
University General Hospital Of Ioannina Ioannina Greece
Internationale Innovative Ophthalmochirurgie GbR (I.I.O.) Duesseldorf Germany
Hospital Universitario Virgen Macarena Sevilla Spain
Augenzentrum Prof. Dr. Koch GmbH Frankfurt Germany
Bajcsy-Zsilinszky Korhaz Es Rendelointezet Budapest Hungary
Philipps-Universitaet Marburg Marburg Germany
Semmelweis University Budapest Hungary
Fakultni Nemocnice Kralovske Vinohrady Prague Czechia
Universita’ Politecnica Delle Marche Ancona Italy
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W Krakowie Cracow Poland
Rheinische Friedrich-Wilhelms-Universitaet Bonn Bonn Germany
General University Hospital Of Patras Patras Greece
Vseobecna Fakultni Nemocnice V Praze Prague Czechia
Jahn Ferenc Del-Pesti Korhaz Es Rendelointezet Budapest Hungary
Centro Hospitalar Universitario De Santo Antonio E.P.E. Porto Portugal
University Of Pecs Pecs Hungary
University Of Szeged Szeged Hungary
IRCCS Ospedale Sacro Cuore Don Calabria Negrar di Valpolicella Italy
Budapest Retina Associates Budapest Hungary
Aqnb Cuaivgzb sxtjiu Prague Czechia
Mwezwrl Pirmqvf Cjwb samefi Sokolov Czechia
Vyzru suand s rbmd Nachod Czechia
Aqywxdiqzmjvabgaeziwsm Ahaus Germany
Dse mzma Sjmqvs Svvugq udw Pyjks Dfl mrgb Auegvu Jw Andrswfp Aeyrzueqbeqjlre Baden-Baden Germany
Bktfxtegz Shcm Bilbao Spain
Sfrjizb Sde Rrnb Sjo z ofmt Stzk Cracow Poland
Knyjmsw Oztwpbzekork Jdubk Btgons Shr z oqux Lodz Poland
Ogmbmziatki Sba z ocvz Bydgoszcz Poland
Czzzwyy Mrmvkriv Dbnzzy 1x Sys z obxm Cracow Poland
Lhdsp Ghhozsh Hvyqdopa Oz Aexvod Athens Greece
Aecgiaz Objwsibimqh Uteppbdwujdpn Crpdljlgicdk Dlvjp Sxohiq E Dfsze Shcrpkj Dg Txlybn Turin Italy
Uwetmqmfswrijwzsijcao Wacykkqnt Ajh Wuerzburg Germany
Aklsxht Ugxfh Sizdjpple Lqvwcv Dp Bxrmcui Bologna Italy
Pkdxnltkajsg Cgvrbvh Mqrifedv Sen z oxzv Gdansk Poland
Unvfiwysop Gykdgwt Hqflernu Afxjidt Athens Greece
Kpqemyy Dge Blsijdzicyjs Blffpkr Linz Austria

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Austria Austria
Recruiting
02.06.2025
Czechia Czechia
Recruiting
02.06.2025
Germany Germany
Recruiting
02.06.2025
Greece Greece
Recruiting
02.06.2025
Hungary Hungary
Recruiting
02.06.2025
Italy Italy
Not yet recruiting
02.06.2025
Poland Poland
Recruiting
02.06.2025
Portugal Portugal
Recruiting
02.06.2025
Spain Spain
Recruiting
02.06.2025

Trial locations

Investigated drugs:

ONL1204 is an investigational medication being studied for treating geographic atrophy (GA), a severe form of age-related macular degeneration (AMD) that can lead to vision loss. The medication is administered through injections and is designed to help slow down or prevent the progression of geographic atrophy in patients with AMD. This is a new treatment being tested to potentially help preserve vision in people affected by this condition.

The trial also includes sham injections as a control measure, which means some participants receive a simulated procedure without actual medication to compare the effectiveness of ONL1204.

Age-related Macular Degeneration (AMD) – A progressive eye condition that affects the central part of the retina called the macula. The disease exists in two forms, with the atrophic (dry) form characterized by the gradual breakdown of light-sensitive cells in the macula. In atrophic AMD, small yellow deposits called drusen develop under the retina, and the macula slowly thins and degenerates over time. This leads to the development of geographic atrophy (GA), where patches of retinal tissue deteriorate, creating areas of vision loss in the central field of vision. The condition typically develops gradually over several years, primarily affecting people over the age of 50. Vision changes occur slowly, with affected individuals experiencing increasing difficulty with detailed tasks like reading or recognizing faces.

Trial ID:
2024-513174-22-00
Protocol code:
ONL1204-GA-002
NCT ID:
NCT06659445
Trial Phase:
Therapeutic exploratory (Phase II)

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