Home › Trials › NCT06007690

Evaluating a new treatment for small choroidal melanoma and indeterminate lesions

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

PHASE3 · Aura Biosciences · NCT06007690

This study is testing a new treatment for small choroidal melanoma and uncertain eye lesions to see if it works better than a placebo.

Quick facts

PhasePHASE3
Study typeInterventional
Enrollment100 (estimated)
Ages18 Years and up
SexAll
SponsorAura Biosciences (industry)
Locations71 sites (Birmingham, Alabama and 70 other locations)
Trial IDNCT06007690 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to assess the safety and efficacy of belzupacap sarotalocan (bel-sar) compared to a sham control in patients diagnosed with primary indeterminate lesions or small choroidal melanoma. The study employs a randomized, sham-controlled design, where participants receive either the bel-sar treatment via a suprachoroidal microinjector or a placebo. The treatment is activated using a laser photoactivation device, and the trial is masked for subjects, assessors, and sponsors to ensure unbiased results. The primary goal is to determine how well this new treatment works in comparison to no active treatment.

Who should consider this trial

Good fit: Ideal candidates include individuals with a clinical diagnosis of primary indeterminate lesions or small choroidal melanoma who have not received prior treatment.

Not a fit: Patients with known contraindications to the study drug or laser, or those with active ocular infections or diseases, may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new effective option for patients with small choroidal melanoma and indeterminate lesions.

How similar studies have performed: Other studies have shown promise with similar approaches in treating ocular melanoma, but this specific treatment is novel.

Eligibility criteria

Show full inclusion / exclusion criteria 
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

Where this trial is running

Birmingham, Alabama and 70 other locations

+21 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Choroidal Melanoma, Indeterminate Lesions, Uveal Melanoma, Ocular Melanoma, Eye Cancer

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.