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

NCT06007690 · tracked via the Priya Life Science Germany tracker

Sponsor

Aura Biosciences

Phase

Phase 3

Started

2023-12-06

Last updated

2026-07-31

Condition(s) studied

Choroidal MelanomaIndeterminate LesionsUveal MelanomaOcular Melanoma

Investigational drug(s) / intervention(s)

Bel-sar →Suprachoroidal MicroinjectorInfrared LaserSham Infrared LaserSham Microinjector

Bel-sar: Bel-sar via suprachoroidal administration followed by laser application.

Suprachoroidal Microinjector: Suprachoroidal injection device

Infrared Laser: Laser application

Sham Infrared Laser: Sham laser application

Sham Microinjector: Sham injection device

Study summary

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).

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: * 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) Exclusion Criteria: * Have known contraindications or sensitivities to the study drug or laser * Active ocular infection or disease

Primary outcome measure(s)

Time to reach tumor progression — 65 weeks
Tumor Progression

Trial sites (66)

Facility	City	Region
UCSD Shiley Eye Institute, Jacobs Retina Center	La Jolla	California
Doris Stein Eye Research Center	Los Angeles	California
Stanford University School of Medicine	Palo Alto	California
Retinal Consultants Medical Group, Inc.	Sacramento	California
Retina Associates of Florida, PA	Tampa	Florida
Emory Eye Center	Atlanta	Georgia
University of Illinois at Chicago	Chicago	Illinois
Tufts Medical Center New England Eye Center	Boston	Massachusetts
Massachusetts Eye and Ear	Boston	Massachusetts
W.K. Kellogg Eye Center - University of Michigan	Ann Arbor	Michigan
Associated Retinal Consultants (ARC) P.C.	Royal Oak	Michigan
Mayo Clinic	Rochester	Minnesota
Washington University	St Louis	Missouri
Nebraska Medicine's Truhlsen Eye Institute	Omaha	Nebraska
Columbia University Irving Medical Center	New York	New York
Cole Eye Institute	Cleveland	Ohio
Dean McGee Eye Institute	Oklahoma City	Oklahoma
Retina Consultants of Oklahoma	Oklahoma City	Oklahoma
Shields & Shields PC-Wills Eye Institute	Philadelphia	Pennsylvania
Retina Consultants of Carolina	Greenville	South Carolina
Southeastern Retina Associates	Chattanooga	Tennessee
Tennessee Retina, PC	Nashville	Tennessee
Austin Retina Associates	Austin	Texas
Texas Retina Associates	Dallas	Texas
Retina Associates of South Texas, P.A.	San Antonio	Texas
Retina Center of Texas	Southlake	Texas
Retina Consultants of Texas	The Woodlands	Texas
Retina Associates of Utah	Salt Lake City	Utah
Vitreoretinal Associates of Washington	Bellevue	Washington
Pacific NW Retina	Burlington	Washington
University of Washington Medical Center	Seattle	Washington
University of Wisconsin Madison	Madison	Wisconsin
Eye Research Australia	East Melbourne	Victoria
Medical University Graz	Graz	Austria
Medizinische Universität Wien, Department of Ophthalmology and Optometry	Vienna	Austria
Cliniques universitaires Saint-Luc	Brussels	Belgium
UZ Leuven	Leuven	Belgium
Serac Eye and Skin Care Centre	Calgary	Alberta
Centre Hospitalier de l'Universite Laval	Québec	Quebec
Fakultni Thomayerova nemocnice	Prague	Krč

+ 26 more sites — see the full list on the official registry below.

Other trials for the same condition

Neoadjuvant Darovasertib in Primary Uveal Melanoma Recruiting

(Neo)Adjuvant IDE196 (Darovasertib) in Patients With Localized Ocular Melanoma Active, not recruiting

A Prospective Natural History Study in Uveal Melanoma Active, not recruiting

Adjuvant Tebentafusp in High Risk Ocular Melanoma Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06007690 on ClinicalTrials.gov ↗ ← All trials in Germany