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
Sites (61)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Medical University of Graz Coordinator of this site? Confirm its status | Graz | Austria | Active, not recruiting |
| Medical University of Vienna Coordinator of this site? Confirm its status | Vienna | Austria | Active, not recruiting |
| Eye Research Australia Coordinator of this site? Confirm its status | East Melbourne | Australia | Unknown status |
| UZ Leuven Coordinator of this site? Confirm its status | Leuven | Belgium | Active, not recruiting |
| Cliniques Universitaires Saint-Luc Coordinator of this site? Confirm its status | Sint-Lambrechts-Woluwe | Belgium | Active, not recruiting |
| Serac Eye and Skin Care Centre Coordinator of this site? Confirm its status | Calgary | Canada | Unknown status |
| Fakultni Nemocnice Plzen Coordinator of this site? Confirm its status | Plzen 23 | Czechia | Active, not recruiting |
| Fakultni Thomayerova nemocnice Coordinator of this site? Confirm its status | Prague 4 | Czechia | Active, not recruiting |
| Ustredni Vojenska Nemocnice Vojenska Fakultni Nemocnice Praha Coordinator of this site? Confirm its status | Prague 6 | Czechia | Active, not recruiting |
| Charite Universitaetsmedizin Berlin KöR Coordinator of this site? Confirm its status | Berlin | Germany | Active, not recruiting |
| University Hospital Cologne AöR Coordinator of this site? Confirm its status | Cologne | Germany | Active, not recruiting |
| Universitaetsklinikum Essen (AoR) Coordinator of this site? Confirm its status | Essen | Germany | Active, not recruiting |
| University Medical Center Hamburg-Eppendorf Coordinator of this site? Confirm its status | Hamburg | Germany | Active, not recruiting |
| Universitaetsklinikum Schleswig-Holstein Coordinator of this site? Confirm its status | Lübeck | Germany | Active, not recruiting |
| Klinikum der Universitaet Muenchen AöR Coordinator of this site? Confirm its status | Munich | Germany | Active, not recruiting |
| Universitaetsklinikum Tuebingen AöR Coordinator of this site? Confirm its status | Tuebingen | Germany | Active, not recruiting |
| Rigshospitalet Coordinator of this site? Confirm its status | Copenhagen Oe | Denmark | Completed |
| Bellvitge University Hospital Coordinator of this site? Confirm its status | L'hospitalet De Llobregat | Spain | Active, not recruiting |
| Complexo Hospitalario Universitario De Santiago Coordinator of this site? Confirm its status | Santiago de Compostela | Spain | Active, not recruiting |
| Hospital Universitario Virgen De La Macarena Coordinator of this site? Confirm its status | Sevilla | Spain | Active, not recruiting |
| Hospital Universitario Y Politecnico La Fe Coordinator of this site? Confirm its status | Valencia | Spain | Active, not recruiting |
| Hospices Civils De Lyon Coordinator of this site? Confirm its status | Lyon Cedex 04 | France | Active, not recruiting |
| Centre Hospitalier Universitaire de Nice Coordinator of this site? Confirm its status | Nice | France | Active, not recruiting |
| Moorfields Eye Hospital NHS Foundation Trust Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| Nhs Foundation Trust - Royal Hallamshire Hospital Coordinator of this site? Confirm its status | Sheffield | United Kingdom | Unknown status |
| Mitera S.A. Coordinator of this site? Confirm its status | Marousi | Greece | Completed |
| Royal Victoria Eye And Ear Hospital Coordinator of this site? Confirm its status | Dublin 2 | Ireland | Completed |
| The Chaim Sheba Medical Center Coordinator of this site? Confirm its status | Tel-Hashomer | Israel | Unknown status |
| Careggi University Hospital Coordinator of this site? Confirm its status | Florence | Italy | Active, not recruiting |
| ASST Fatebenefratelli Sacco Coordinator of this site? Confirm its status | Milan | Italy | Active, not recruiting |
| Fondazione IRCCS - Istituto Nazionale dei Tumori Coordinator of this site? Confirm its status | Milan | Italy | Active, not recruiting |
| Fondazione Policlinico Universitario Agostino Gemelli IRCCS Coordinator of this site? Confirm its status | Rome | Italy | Active, not recruiting |
| Academisch Ziekenhuis Leiden Coordinator of this site? Confirm its status | Leiden | Netherlands | Active, not recruiting |
| Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC) Coordinator of this site? Confirm its status | Rotterdam | Netherlands | Active, not recruiting |
| Auckland Eye Ltd Coordinator of this site? Confirm its status | Auckland | New Zealand | Unknown status |
| St Erik Eye Hospital Coordinator of this site? Confirm its status | Solna | Sweden | Completed |
| W.K. Kellogg Eye Center - University of Michigan Coordinator of this site? Confirm its status | Ann Arbor | United States | Unknown status |
| Emory Eye Center Coordinator of this site? Confirm its status | Atlanta | United States | Unknown status |
| Austin Retina Associates Coordinator of this site? Confirm its status | Austin | United States | Unknown status |
| Vitreoretinal Associates of Washington Coordinator of this site? Confirm its status | Bellevue | United States | Unknown status |
| Massachusetts Eye and Ear Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| Tufts Medical Center New England Eye Center Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| University of Illinois at Chicago Coordinator of this site? Confirm its status | Chicago | United States | Unknown status |
| Cole Eye Institute Coordinator of this site? Confirm its status | Cleveland | United States | Unknown status |
| Texas Retina Associates Coordinator of this site? Confirm its status | Dallas | United States | Unknown status |
| Retina Consultants of Carolina Coordinator of this site? Confirm its status | Greenville | United States | Unknown status |
| Eye Cancer Associates of Texas Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| Doris Stein Eye Research Center Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
| University of Wisconsin - Madison Coordinator of this site? Confirm its status | Madison | United States | Unknown status |
| Tennessee Retina, PC Coordinator of this site? Confirm its status | Nashville | United States | Unknown status |
| Columbia University Irving Medical Center Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Dean McGee Eye Institute Coordinator of this site? Confirm its status | Oklahoma City | United States | Unknown status |
| Retina Consultants of Oklahoma Coordinator of this site? Confirm its status | Oklahoma City | United States | Unknown status |
| Stanford University, School of Medicine Coordinator of this site? Confirm its status | Palo Alto | United States | Unknown status |
| Shields & Shields PC-Wills Eye Institute Coordinator of this site? Confirm its status | Philadelphia | United States | Unknown status |
| Mayo Clinic Coordinator of this site? Confirm its status | Rochester | United States | Unknown status |
| Associated Retinal Consultants (ARC) P.C. Coordinator of this site? Confirm its status | Royal Oak | United States | Unknown status |
| Retinal Consultants Medical Group, Inc. Coordinator of this site? Confirm its status | Sacramento | United States | Unknown status |
| Retina Associates of Utah Coordinator of this site? Confirm its status | Salt Lake City | United States | Unknown status |
| University of Washington Medical Center Coordinator of this site? Confirm its status | Seattle | United States | Unknown status |
| Retina Center of Texas Coordinator of this site? Confirm its status | Southlake | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.