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NCT06007690 · ClinicalTrials.gov registry record · Phase 3
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
A Phase 3 study of Uveal Melanoma and Ocular Melanoma, sponsored by Aura Biosciences.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 100
- Enrollment target
- 20
- Study locations
NCT06007690: Recruiting Phase 3 study of Uveal Melanoma and Ocular Melanoma, sponsored by Aura Biosciences.
NCT06007690 is a Phase 3 study of Uveal Melanoma and Ocular Melanoma that is actively recruiting participants, run by Aura Biosciences. The registered enrollment target is 100 participants, below the 142-participant average among 29 other Uveal Melanoma trials with a reported enrollment target (30% lower). The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06007690, a Phase 3 study of Uveal Melanoma and Ocular Melanoma, is actively recruiting participants, sponsored by Aura Biosciences.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 100 participants
- Enrollment target
- 20
- Study locations
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).
Primary Outcome
Tumor Progression
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 |
What NCT06007690 shows while recruiting
NCT06007690 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, below the 142-participant average among 29 other Uveal Melanoma trials with a reported enrollment target (30% lower).
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.
NCT06007690 names 20 study sites across 14 states, led by California, Florida, Massachusetts.
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.
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).
Who is sponsoring clinical trial NCT06007690?
This trial is sponsored by Aura Biosciences, which has 7 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
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Where NCT06007690's enrollment target sits among peer trials
100 11th of 29 higher than 19 of 29 other Uveal Melanoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Uveal Melanoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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