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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 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2026-03-02

No results posted yet for this 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).

Conditions

  • Choroidal Melanoma
  • Indeterminate Lesions
  • Uveal Melanoma
  • Ocular Melanoma

Interventions

DRUG

Bel-sar

Bel-sar via suprachoroidal administration followed by laser application.

DEVICE

Suprachoroidal Microinjector

Suprachoroidal injection device

DEVICE

Infrared Laser

Laser application

DEVICE

Sham Infrared Laser

Sham laser application

DEVICE

Sham Microinjector

Sham injection device

Sponsors & Collaborators

  • Aura Biosciences

    lead INDUSTRY

Principal Investigators

  • Medical Monitor · Aura Biosciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-06
Primary Completion
2027-11-15
Completion
2028-08-15
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States
  • Australia
  • Austria
  • Belgium
  • Canada
  • Czechia
  • France
  • Germany
  • Israel
  • Italy
  • Netherlands
  • New Zealand
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06007690 on ClinicalTrials.gov