NCT04757636CompletedPhase 3
A clinical study of OPT-302 with aflibercept compared to aflibercept alone in patients with neovascular age-related macular degeneration
A Phase 3, Multicentre, Double-masked, Randomised Study to Evaluate the Efficacy and Safety of Intravitreal OPT-302 in Combination with Aflibercept, Compared with Aflibercept Alone, in Participants with Neovascular Age-related Macular Degeneration (nAMD)
Source: EU CTIS (euclinicaltrials.eu) · Last updated 23 Apr 2025
Brief summary (registry, in English)
To determine the efficacy of intravitreal 2.0 mg OPT-302 when administered in combination with intravitreal 2.0 mg aflibercept, in participants with neovascular AMD
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 475 (actual)
- First submitted
- 26 Jul 2024
- Start date
- 27 Aug 2021
- Lead sponsor
- Opthea Limited
- Diseases
- Macular degeneration
- NCT number
- NCT04757636
- EU CT number
- 2024-512880-30-00
- EudraCT number
- 2020-004694-46
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 475
- 61 sites in 16 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study, not your situation.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Study Eye • Any previous treatment for neovascular AMD.
Other illness
- Clinically significant ocular disorders (other than neovascular AMD), which may interfere with assessment of BCVA, assessment of safety, or fundus imaging.
Who the study is looking for
- Male or female participants at least 50 years of age.
- Active subfoveal CNV lesion or juxtafoveal CNV lesion with foveal involvement that is secondary to AMD in the Study Eye.
- An ETDRS BCVA score between 60 and 25 (inclusive) letters in the Study Eye.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (61)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Medical University of Graz Coordinator of this site? Confirm its status | Graz | Austria | Completed |
| MBAL Trakia EOOD Coordinator of this site? Confirm its status | Stara Zagora | Bulgaria | Completed |
| Fakultni nemocnice Brno Coordinator of this site? Confirm its status | Brno | Czechia | Completed |
| Fakultni Nemocnice Hradec Kralove Coordinator of this site? Confirm its status | Novy Hradec Kralove | Czechia | Completed |
| Vseobecna fakultni nemocnice v Praze Coordinator of this site? Confirm its status | Prague | Czechia | Completed |
| Fakultni nemocnice Kralovske Vinohrady Coordinator of this site? Confirm its status | Prague | Czechia | Completed |
| Fakultni Thomayerova nemocnice Coordinator of this site? Confirm its status | Prague 4 | Czechia | Completed |
| Axon Clinical s.r.o. Coordinator of this site? Confirm its status | Prague 5 | Czechia | Completed |
| Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR Coordinator of this site? Confirm its status | Mainz | Germany | Completed |
| Universitaetsklinikum Tuebingen AöR Coordinator of this site? Confirm its status | Tuebingen | Germany | Completed |
| East Tallinn Central Hospital Coordinator of this site? Confirm its status | Tallinn | Estonia | Completed |
| Silmalaser OÜ Coordinator of this site? Confirm its status | Tallinn | Estonia | Completed |
| Silmaarst Krista Turman OÜ Coordinator of this site? Confirm its status | Tallinn | Estonia | Completed |
| Hospital Germans Trias i Pujol Coordinator of this site? Confirm its status | Badalona | Spain | Completed |
| Institut Catala De Retina S.L. Coordinator of this site? Confirm its status | Barcelona | Spain | Completed |
| Hospital Universitari Vall d'Hebron Coordinator of this site? Confirm its status | Barcelona | Spain | Completed |
| Bellvitge University Hospital Coordinator of this site? Confirm its status | L'hospitalet De Llobregat | Spain | Completed |
| Hospital Universitario Puerta de Hierro de Majadahonda Coordinator of this site? Confirm its status | Majadahonda | Spain | Completed |
| Instituto Oftalmologico Fernandez-Vega S.L. Coordinator of this site? Confirm its status | Oviedo | Spain | Completed |
| Fundacion Para El Fomento De La Investigacion Sanitaria Y Biomedica De La Comunitat Valenciana Coordinator of this site? Confirm its status | Valencia | Spain | Completed |
| Hospital Clinico Universitario Lozano Blesa Coordinator of this site? Confirm its status | Zaragoza | Spain | Completed |
| Hospital Universitario Miguel Servet Coordinator of this site? Confirm its status | Zaragoza | Spain | Completed |
| Centre Hospitalier Universitaire de Dijon Coordinator of this site? Confirm its status | Dijon | France | Completed |
| Assistance Publique Hopitaux de Paris Coordinator of this site? Confirm its status | Paris | France | Completed |
| University General Hospital Attikon Coordinator of this site? Confirm its status | Athens | Greece | Completed |
| University General Hospital of Heraklion Coordinator of this site? Confirm its status | Heraklion | Greece | Completed |
| General University Hospital of Larissa Coordinator of this site? Confirm its status | Larissa | Greece | Completed |
| Oftalmoloska Poliklinika Dr. Balog d.o.o. Coordinator of this site? Confirm its status | Osijek | Croatia | Completed |
| Klinički bolnički centar Osijek Coordinator of this site? Confirm its status | Osijek | Croatia | Completed |
| KBC Split Coordinator of this site? Confirm its status | Split | Croatia | Completed |
| Budapesti Bajcsy-Zsilinszky Korhaz Es Rendelointezet Coordinator of this site? Confirm its status | Budapest | Hungary | Completed |
| Central Hospital Of Northern Pest Military Hospital Coordinator of this site? Confirm its status | Budapest VI | Hungary | Completed |
| Semmelweis University Coordinator of this site? Confirm its status | Budapest VIII | Hungary | Completed |
| University of Debrecen Coordinator of this site? Confirm its status | Debrecen | Hungary | Completed |
| University of Pecs Coordinator of this site? Confirm its status | Pécs | Hungary | Completed |
| Nozologen Kft. Coordinator of this site? Confirm its status | Pécs | Hungary | Completed |
| Zala Varmegyei Szent Rafael Korhaz Coordinator of this site? Confirm its status | Zalaegerszeg | Hungary | Completed |
| Careggi University Hospital Coordinator of this site? Confirm its status | Florence | Italy | Completed |
| Ospedale San Raffaele S.r.l. Coordinator of this site? Confirm its status | Milan | Italy | Completed |
| Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico Coordinator of this site? Confirm its status | Milan | Italy | Completed |
| ASST Fatebenefratelli Sacco Coordinator of this site? Confirm its status | Milan | Italy | Completed |
| Hospital Santa Maria Della Misericordia Coordinator of this site? Confirm its status | Perugia | Italy | Completed |
| Fondazione G.B.Bietti Per Lo Studio E La Ricerca In Oftalmologia Coordinator of this site? Confirm its status | Rome | Italy | Completed |
| Humanitas Mirasole S.p.A. Coordinator of this site? Confirm its status | Rozzano | Italy | Completed |
| Lietuvos sveikatos mokslu universiteto ligonine Kauno klinikos Coordinator of this site? Confirm its status | Kaunas | Lithuania | Completed |
| Klaipedos universiteto ligonine VšĮ Coordinator of this site? Confirm its status | Klaipeda | Lithuania | Completed |
| Vilniaus universiteto ligonine Santaros klinikos VšĮ Coordinator of this site? Confirm its status | Vilnius | Lithuania | Completed |
| Rigas Austrumu kliniska universitates slimnica SIA Coordinator of this site? Confirm its status | Riga | Latvia | Completed |
| Pauls Stradins Clinical University Hospital Coordinator of this site? Confirm its status | Riga | Latvia | Completed |
| The Rotterdam Eye Hospital Coordinator of this site? Confirm its status | Rotterdam | Netherlands | Completed |
| Stichting Elisabeth-TweeSteden Ziekenhuis Coordinator of this site? Confirm its status | Tilburg | Netherlands | Completed |
| Szpital Swietego Lukasza S. A. Coordinator of this site? Confirm its status | Bielsko-Biala | Poland | Completed |
| OFTALMIKA Sp. z o.o Coordinator of this site? Confirm its status | Bydgoszcz | Poland | Completed |
| Oculomedica Sp. z o.o. Coordinator of this site? Confirm its status | Bydgoszcz | Poland | Completed |
| Santa SP. z o.o Coordinator of this site? Confirm its status | Lodz | Poland | Completed |
| Mackiewicz Okulistyka Sp. z o.o. Coordinator of this site? Confirm its status | Lublin | Poland | Completed |
| Poznanskie Centrum Wzroku sp z o o Coordinator of this site? Confirm its status | Poznan | Poland | Completed |
| University Hospital Bratislava Coordinator of this site? Confirm its status | Bratislava | Slovakia | Completed |
| Nemocnica s poliklinikou Trebisov a.s. Coordinator of this site? Confirm its status | Trebišov | Slovakia | Completed |
| Fakultna nemocnica Trencin Coordinator of this site? Confirm its status | Trenčín | Slovakia | Completed |
| Fakultna nemocnica s poliklinikou Zilina Coordinator of this site? Confirm its status | Žilina | Slovakia | Completed |
Related publications
- Neovascular age-related macular degeneration management - Beyond anti-VEGF.Indian J Ophthalmol · 2026 · PMID 42054085
This page is information, not medical advice. Discuss any trial with your doctor.