Phase 2 Trial to Evaluate Belzupacap Sarotalocan (AU-011) Via Suprachoroidal Administration in Subjects With Primary Indeterminate Lesions and Small Choroidal Melanoma

Phase 2

Completed

• Conditions: Uveal Melanoma; Ocular Melanoma; Choroidal Melanoma

• Registration Number: NCT04417530
• Lead Sponsor: Aura Biosciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-6-2
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 22

Inclusion Criteria

Inclusion Criteria:<br><br> - Clinical diagnosis of primary indeterminate lesion or small choroidal melanoma<br> (IL/CM)<br><br> - Have no evidence of metastatic disease confirmed by imaging<br><br> - Be treatment naïve for IL/CM<br><br>Exclusion Criteria:<br><br> - Have known contraindications or sensitivities to the study drug or laser<br><br> - Active ocular disease

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Treatment related AEs and treatment related serious adverse events (SAEs).

Secondary Outcome Measures

Name	Time	Method
Within-subject difference of historical tumor thickness growth rate and post-treatment growth rate over 52 weeks.;Time to reach tumor progression