Status:
RECRUITING
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
Lead Sponsor:
Aura Biosciences
Conditions:
Choroidal Melanoma
Indeterminate Lesions
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 melano...
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 ...
Eligibility Criteria
Inclusion
- 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
- Have known contraindications or sensitivities to the study drug or laser
- Active ocular infection or disease
Key Trial Info
Start Date :
December 6 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 15 2028
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT06007690
Start Date
December 6 2023
End Date
August 15 2028
Last Update
November 24 2025
Active Locations (66)
Enter a location and click search to find clinical trials sorted by distance.
1
Retina Consultants of Alabama
Birmingham, Alabama, United States, 35233
2
UCSD Shiley Eye Institute, Jacobs Retina Center
La Jolla, California, United States, 92093
3
Doris Stein Eye Research Center
Los Angeles, California, United States, 90095
4
Stanford University School of Medicine
Palo Alto, California, United States, 94303