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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 · View on ClinicalTrials.gov ↗
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 Studied
Interventions
- DRUG Bel-sar
- DEVICE Suprachoroidal Microinjector
- DEVICE Infrared Laser
- DEVICE Sham Infrared Laser
- DEVICE Sham Microinjector
Study Locations (20)
California
- UCSD Shiley Eye Institute, Jacobs Retina Center — La Jolla
- Doris Stein Eye Research Center — Los Angeles
- Stanford University School of Medicine — Palo Alto
- Retinal Consultants Medical Group, Inc. — Sacramento
Florida
- Bascom Palmer Eye Institute — Miami
- Retina Associates of Florida, PA — Tampa
Massachusetts
- Tufts Medical Center New England Eye Center — Boston
- Massachusetts Eye and Ear — Boston
Michigan
- W.K. Kellogg Eye Center - University of Michigan — Ann Arbor
- Associated Retinal Consultants (ARC) P.C. — Royal Oak
Alabama
- Retina Consultants of Alabama — Birmingham
Georgia
- Emory Eye Center — Atlanta
Illinois
- University of Illinois at Chicago — Chicago
Minnesota
- Mayo Clinic — Rochester
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2023-12-06 |
| Est. Completion | 2028-08-15 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06007690
The ClinicalTrials.gov registry entry for NCT06007690 describes a study currently listed as recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 100 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Aura Biosciences, which has 35 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 4 conditions, with Uveal Melanoma appearing as the primary indexed condition, and to 5 interventions — of which Bel-sar is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06007690 reports 20 study locations spanning 14 distinct geographic areas — top geographies include California, Florida, Massachusetts. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06007690 about?
NCT06007690 is a clinical study titled "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". 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).
What is the current status of trial NCT06007690?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 100 participants. The study started on 2023-12-06. Estimated completion is 2028-08-15.
What conditions does trial NCT06007690 study?
This clinical trial studies the following conditions: Uveal Melanoma, Ocular Melanoma, Choroidal Melanoma, Indeterminate Lesions. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06007690?
The interventions under investigation include: Bel-sar (DRUG), Suprachoroidal Microinjector (DEVICE), Infrared Laser (DEVICE), Sham Infrared Laser (DEVICE), Sham Microinjector (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06007690?
This trial is sponsored by Aura Biosciences, which has 35 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06007690 being conducted?
This trial has 20 study locations across Alabama, California, Florida, Georgia, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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