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NCT06007690Active, not recruitingPhase 3

A Phase 3 Randomized, Masked, Controlled Trial to Evaluate Efficacy and Safety of Belzupacap Sarotalocan (AU-011) Treatment Compared to Sham Control in Subjects With Primary Indeterminate Lesions or Small Choroidal Melanoma

Source: ClinicalTrials.gov · Last updated 13 Oct 2026

Brief summary (registry, in English)

The primary objective is to determine the safety and efficacy of belzupacap sarotalocan (bel-sar) compared to sham control in patients with primary indeterminate lesions (IL) or small choroidal melanoma (CM).

Status (registry)
Active, not recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
108 (actual)
First submitted
17 Aug 2023
Start date
6 Dec 2023
Primary completion date
15 Nov 2027
Lead sponsor
Aura Biosciences
Diseases
Melanoma
NCT number
NCT06007690
EU CT number
2023-504655-27-00

What you commit to

  • Study type: Interventional · Phase 3
  • Participants enrolled: 108
  • From 6 Dec 2023 to the primary completion date, 15 Nov 2027
  • 61 sites in 18 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Have known contraindications or sensitivities to the study drug or laser

Other illness

  • Active ocular infection or disease

Who the study is looking for

  • Clinical diagnosis of primary indeterminate lesion or small choroidal melanoma (IL/CM)
  • Have no evidence of metastatic disease confirmed by imaging
  • Be treatment naive for IL/CM (subjects who received PDT may be eligible)

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (61)

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

SiteCityCountrySite status
Medical University of Graz
Coordinator of this site? Confirm its status
GrazAustriaActive, not recruiting
Medical University of Vienna
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ViennaAustriaActive, not recruiting
Eye Research Australia
Coordinator of this site? Confirm its status
East MelbourneAustraliaUnknown status
UZ Leuven
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LeuvenBelgiumActive, not recruiting
Cliniques Universitaires Saint-Luc
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Sint-Lambrechts-WoluweBelgiumActive, not recruiting
Serac Eye and Skin Care Centre
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CalgaryCanadaUnknown status
Fakultni Nemocnice Plzen
Coordinator of this site? Confirm its status
Plzen 23CzechiaActive, not recruiting
Fakultni Thomayerova nemocnice
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Prague 4CzechiaActive, not recruiting
Ustredni Vojenska Nemocnice Vojenska Fakultni Nemocnice Praha
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Prague 6CzechiaActive, not recruiting
Charite Universitaetsmedizin Berlin KöR
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BerlinGermanyActive, not recruiting
University Hospital Cologne AöR
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CologneGermanyActive, not recruiting
Universitaetsklinikum Essen (AoR)
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EssenGermanyActive, not recruiting
University Medical Center Hamburg-Eppendorf
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HamburgGermanyActive, not recruiting
Universitaetsklinikum Schleswig-Holstein
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LübeckGermanyActive, not recruiting
Klinikum der Universitaet Muenchen AöR
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MunichGermanyActive, not recruiting
Universitaetsklinikum Tuebingen AöR
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TuebingenGermanyActive, not recruiting
Rigshospitalet
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Copenhagen OeDenmarkCompleted
Bellvitge University Hospital
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L'hospitalet De LlobregatSpainActive, not recruiting
Complexo Hospitalario Universitario De Santiago
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Santiago de CompostelaSpainActive, not recruiting
Hospital Universitario Virgen De La Macarena
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SevillaSpainActive, not recruiting
Hospital Universitario Y Politecnico La Fe
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ValenciaSpainActive, not recruiting
Hospices Civils De Lyon
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Lyon Cedex 04FranceActive, not recruiting
Centre Hospitalier Universitaire de Nice
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NiceFranceActive, not recruiting
Moorfields Eye Hospital NHS Foundation Trust
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LondonUnited KingdomUnknown status
Nhs Foundation Trust - Royal Hallamshire Hospital
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SheffieldUnited KingdomUnknown status
Mitera S.A.
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MarousiGreeceCompleted
Royal Victoria Eye And Ear Hospital
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Dublin 2IrelandCompleted
The Chaim Sheba Medical Center
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Tel-HashomerIsraelUnknown status
Careggi University Hospital
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FlorenceItalyActive, not recruiting
ASST Fatebenefratelli Sacco
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MilanItalyActive, not recruiting
Fondazione IRCCS - Istituto Nazionale dei Tumori
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MilanItalyActive, not recruiting
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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RomeItalyActive, not recruiting
Academisch Ziekenhuis Leiden
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LeidenNetherlandsActive, not recruiting
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
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RotterdamNetherlandsActive, not recruiting
Auckland Eye Ltd
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AucklandNew ZealandUnknown status
St Erik Eye Hospital
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SolnaSwedenCompleted
W.K. Kellogg Eye Center - University of Michigan
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Ann ArborUnited StatesUnknown status
Emory Eye Center
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AtlantaUnited StatesUnknown status
Austin Retina Associates
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AustinUnited StatesUnknown status
Vitreoretinal Associates of Washington
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BellevueUnited StatesUnknown status
Massachusetts Eye and Ear
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BostonUnited StatesUnknown status
Tufts Medical Center New England Eye Center
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BostonUnited StatesUnknown status
University of Illinois at Chicago
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ChicagoUnited StatesUnknown status
Cole Eye Institute
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ClevelandUnited StatesUnknown status
Texas Retina Associates
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DallasUnited StatesUnknown status
Retina Consultants of Carolina
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GreenvilleUnited StatesUnknown status
Eye Cancer Associates of Texas
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HoustonUnited StatesUnknown status
Doris Stein Eye Research Center
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Los AngelesUnited StatesUnknown status
University of Wisconsin - Madison
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MadisonUnited StatesUnknown status
Tennessee Retina, PC
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NashvilleUnited StatesUnknown status
Columbia University Irving Medical Center
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New YorkUnited StatesUnknown status
Dean McGee Eye Institute
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Oklahoma CityUnited StatesUnknown status
Retina Consultants of Oklahoma
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Oklahoma CityUnited StatesUnknown status
Stanford University, School of Medicine
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Palo AltoUnited StatesUnknown status
Shields & Shields PC-Wills Eye Institute
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PhiladelphiaUnited StatesUnknown status
Mayo Clinic
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RochesterUnited StatesUnknown status
Associated Retinal Consultants (ARC) P.C.
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Royal OakUnited StatesUnknown status
Retinal Consultants Medical Group, Inc.
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SacramentoUnited StatesUnknown status
Retina Associates of Utah
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Salt Lake CityUnited StatesUnknown status
University of Washington Medical Center
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SeattleUnited StatesUnknown status
Retina Center of Texas
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SouthlakeUnited StatesUnknown status

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