Trials / Recruiting
RecruitingNCT06007690
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
- Status
- Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- Sponsor
- Aura Biosciences · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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).
Detailed description
This is a randomized, sham-controlled, subject-, assessor-, and Sponsor- masked trial to establish the safety and efficacy of bel-sar treatment via suprachoroidal (SC) administration in subjects with primary IL/CM. Bel-sar treatment incorporates administration of bel-sar drug product using a suprachoroidal space (SCS) microinjector and activation of bel-sar by a laser photoactivation device.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2023-12-06
- Primary completion
- 2027-11-15
- Completion
- 2028-08-15
- First posted
- 2023-08-23
- Last updated
- 2026-03-02
Locations
71 sites across 14 countries: United States, Australia, Austria, Belgium, Canada, Czechia, France, Germany, Israel, Italy, Netherlands, New Zealand, Spain, United Kingdom
Regulatory
- FDA-regulated drug study
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT06007690. Inclusion in this directory is not an endorsement.