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NCT04757610CompletedPhase 3

A clinical study of OPT-302 with ranibizumab compared to ranibizumab 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 Ranibizumab, Compared with Ranibizumab 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 0.5 mg ranibizumab, in participants with neovascular AMD.

Status (registry)
Completed
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
298 (actual)
First submitted
2 Aug 2024
Start date
23 Sept 2021
Lead sponsor
Opthea Limited
NCT number
NCT04757610
EU CT number
2024-512879-13-00
EudraCT number
2020-004736-24

What you commit to

  • Study type: Interventional · Phase 3
  • Participants enrolled: 298
  • 39 sites in 10 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: 1. • Any previous treatment for neovascular AMD.

Other illness

  • • Clinically significant ocular disorders (other than neovascular AMD), which may, in the investigator's opinion, 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

Full criteria on EU CTIS (euclinicaltrials.eu)

Sites (39)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Oftex s.r.o.
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Pardubice VCzechiaCompleted
Klinika JL MR s.r.o.
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PragueCzechiaCompleted
Fakultni nemocnice Kralovske Vinohrady
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PragueCzechiaCompleted
Medical Private Care s.r.o.
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SokolovCzechiaCompleted
Universitaetsmedizin Goettingen
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GoettingenGermanyCompleted
Universitaetsklinikum Heidelberg AöR
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HeidelbergGermanyCompleted
Universitaetsklinikum Muenster AöR
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MuensterGermanyCompleted
Universitaetsklinikum Ulm AoR
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UlmGermanyCompleted
Aarhus Universitetshospital
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Aarhus NDenmarkCompleted
Rigshospitalet
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GlostrupDenmarkCompleted
Centro De Oftalmologia Barraquer S.A.
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BarcelonaSpainCompleted
Hospital Universitario De Burgos
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BurgosSpainCompleted
Oftalmologia Vistahermosa S.L.
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BurjassotSpainCompleted
Clinica De Oftalmologia De Cordoba S.L.
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CordobaSpainCompleted
Instituto De Microcirugia Ocular Dos S.L.
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MadridSpainCompleted
Hospital Clínico San Carlos
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MadridSpainCompleted
Hospital Universitari General de Catalunya
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Sant Cugat del VallèsSpainCompleted
Hospital Arnau de Vilanova de Valencia
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ValenciaSpainCompleted
Pole Vision Val d'Ouest
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ÉcullyFranceCompleted
Centre Hospitalier Universitaire de Nice
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NiceFranceCompleted
General Hospital of Athens "G. Gennimatas"
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AthensGreeceCompleted
University General Hospital of Ioannina
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IoanninaGreeceCompleted
General University Hospital Of Patras
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PatrasGreeceCompleted
Budapest Retina Associates Kft.
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Budapest XIIIHungaryCompleted
Borsod-Abauj-Zemplen Varmegyei Koezponti Korhaz Es Egyetemi Oktatokorhaz
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MiskolcHungaryCompleted
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
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BolognaItalyCompleted
Azienda Ospedaliero Universitaria Renato Dulbecco
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CatanzaroItalyCompleted
Azienda Sanitaria Locale 2 Lanciano Vasto Chieti
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ChietiItalyCompleted
IRCCS Ospedale Policlinico San Martino
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GenoaItalyCompleted
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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RomeItalyCompleted
Azienda Ospedaliera Universitaria Senese
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SienaItalyCompleted
Azienda Sanitaria Universitaria Friuli Centrale
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UdineItalyCompleted
Pauls Stradins Clinical University Hospital
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RigaLatviaCompleted
Centrum Medyczne Dietla 19 Sp. z o.o.
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CracowPolandCompleted
Centrum Diagnostyki i Mikrochirurgii Oka-Lens Sp. z o.o.
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OlsztynPolandCompleted
Uniwersytecki Szpital Kliniczny Nr 2 PUM w Szczecinie
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SzczecinPolandCompleted
Caminomed Sp. z o.o.
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Tarnowskie GóryPolandCompleted
Eb Group Sp. z o.o.
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WarsawPolandCompleted
Uniwersytecki Szpital Kliniczny im Jana Mikulicza Radeckiego we Wroclawiu
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WroclawPolandCompleted

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This page is information, not medical advice. Discuss any trial with your doctor.