Evaluating a new treatment for small choroidal melanoma and indeterminate lesions

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• UCSD Shiley Eye Institute, Jacobs Retina Center
  La Jolla, California, United States Recruiting
• Doris Stein Eye Research Center
  Los Angeles, California, United States Recruiting
• Stanford University School of Medicine
  Palo Alto, California, United States Recruiting
• Retinal Consultants Medical Group, Inc.
  Sacramento, California, United States Recruiting
• Retina Associates of Florida, PA
  Tampa, Florida, United States Recruiting
• Emory Eye Center
  Atlanta, Georgia, United States Recruiting

+21 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Medical Monitor
• Email: clinical@aurabiosciences.com
• Phone: 617-500-8864

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.