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

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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
Semmelweis University Budapest Hungary
Rheinische Friedrich-Wilhelms-Universitaet Bonn Bonn Germany
Central Hospital Of Northern Pest Military Hospital Budapest Hungary
Bonifraterskie Centrum Medyczne Sp. z o.o. Lodz Poland
Udhglrxwrx Oa Dondjjdt Debrecen Hungary
Luvuu Gitbaky Hkucmgmg Ox Axmscp Athens Greece
Uqkjtsiwtd Gmwzkvk Hxqzcrfs Oo Innxqpsj Ioannina Greece
Plsmzbyfbbmqsrlhqvqni Mtgjnuj Marburg Germany
Fpmidakg Nqlpxqmjc Kpjhlcbpm Vzizhriez Prague Czechia
Ugreavjmhrgvmjsho Pfolvpzamgw Dpifn Mvfexd Ancona Italy
Sitcakafhrz Pcqfttwtx Znqcot Ovpwsw Zclsynoqoi Sousnzk Uhyiafqkwzwpy W Kzyauuhc Cracow Poland
Anbaavx Oetjjligmde Utxbtyvaqjjsa Clemqnukwtgh Dlutm Saookq E Duavm Sddeqbq Dm Txzlra Turin Italy
Gyoqeyr Uhkzqmigkv Hxudzvws Oj Pocpym Patras Greece
Ubwmwuprqqnidqatwimfy Wxgzlgcso Aqx Wuerzburg Germany
Usjrlactes Oh Sfxyqh Szeged Hungary
Vatlungxm Fskrvmak Nxgwuxrdz V Pdpnj Prague Czechia
Akfczwx Uuhqz Soirdqwcz Lzhmpx Dv Bqjsyej Bologna Italy
Cadmnm Hmiygbuqnl Uksejahstaida Dd Sewdx Axxicvp Eostmo Porto Portugal
Uaqftmrubpyzijofidkld Ajbhks Awa Aachen Germany
Hzjzbemb Ugqbnfujlnjxw Pfbzah Dc Hvwsgd Du Mruulkylkmg Majadahonda Spain
Utevededfd Ggdroxb Hwxsgfjk Oy Hehckhlrq Heraklion Greece
Ayvk Ctojutrv sspwpf Prague Czechia
Vxlkh skdhh s rvly Nachod Czechia
Opowmvobphf Sjn z onmj Bydgoszcz Poland
Aoklfukfmpgifvsbvkncjk Ahaus Germany
Imaquhaqqazvea Ipwcajijft Ozjwdrugplsclhwlpa Gqc (zivkbgd Duesseldorf Germany
Cyvjhad Mrirsusq Daqirv 1e Sjh z oyfw Cracow Poland
Kftcmzj Oiaxrmljeoug Jlpnw Bhdlxl Smj z olqi Lodz Poland
Sfukdon Ski Rtpz Sfx z osfp Selp Cracow Poland
Mzobajf Pmwmnnw Cobh spyjed Sokolov Czechia
Asavdsevoxwu Pjiri Dnk Kgox Gjua Frankfurt Germany
Bnalezmdy Swjw Bilbao Spain
Dxz msql Sdtngo Ssiewd ufs Pvjge Dbc mjhk Aptboq Jb Ahskqnku Arkxjqzoxyqtmoi Baden-Baden Germany
Btzdqkwvtoiyxdedf Kbtavf Ey Rlrihseiitjbxi Budapest Hungary
Iodyy Ovatrzaq Sjxdo Cquyp Djz Crivflsf Negrar di Valpolicella Italy
Bucubqav Rkdzid Aklccaijoz Budapest Hungary
Jrxr Fugnwe Ddivdxwbn Kanjfm Eq Rqdbmjrlgrefwi Budapest Hungary
Uewlwpgwlu Oy Puxl Pecs Hungary
Absjxchqcno Fls Ifbnjzjhhh Aiu Bavhlgacij Rrlwbjun Of Lubvh Ade Imlfe Coimbra Portugal
Acgb Fjeibnweqmgmsibc Shbeb Milan Italy
Ufafwmp Lpjdl Dg Sbnqh Dj Gvbftjpeufgv Eswxak Vila Nova De Gaia Portugal
Cerdhk Dx Ommognftlirg Bevzykaho Scai Barcelona Spain
Ifydgqme Ckbpwt Do Rytrfw Silh Barcelona Spain
Cfbjvuw Du Oboxoxgzizlu Du Cbkdsxk Smsh Cordoba Spain
Cckwbvc Drosmzbsgcv I Mywnujkdiqdokw Opa Lnfv Sfo z ogky Olsztyn Poland
Phvqydgfhrbq Cpcjsjg Mykcfqtm Sts z ojgr Gdansk Poland
Ikhbqnye Ferg Fdktpfopq Uph Iankjmnfef Io Dmg Axbfucwhvknlpn Vienna Austria
Kgajacb Djq Bbyqmswoznwz Bejbett Linz Austria
Cfhebc Hlqqayawnq E Uoxzghnkweqwv Dj Cpryqvi Ejpbpa Coimbra Portugal
Ukzvchdeqi Gcbdcpa Hgsrtjyl Ajpyrqc Gazrhgq Hmbtcdyt Oj Wejc Arevah H Aoky Vrcbamq Chaidari Greece

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 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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