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

Phase 3

Recruiting

• Conditions: Ocular Melanoma; Uveal Melanoma; Choroidal Melanoma; Indeterminate Lesions
• Interventions: Drug: Bel-sar; Device: Sham Infrared Laser; Device: Suprachoroidal Microinjector; Device: Sham Microinjector; Device: Infrared Laser

• Registration Number: NCT06007690
• Lead Sponsor: Aura Biosciences

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 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.

Study Timeline

• Study First Submitted: 2023-08-17
• Study First Submitted QC: 2023-08-17
• Study First Posted: 2023-08-23
• Study Start: 2023-12-06
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-20
• Last Update Posted: 2025-07-22
• Primary Completion: 2026-03-01
• Study Completion: 2027-03-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• 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 Criteria

• Have known contraindications or sensitivities to the study drug or laser
• Active ocular infection or disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High dose bel-sar treatment arm & laser application	Bel-sar	High dose of bel-sar + laser application
High dose bel-sar treatment arm & laser application	Suprachoroidal Microinjector	High dose of bel-sar + laser application
High dose bel-sar treatment arm & laser application	Infrared Laser	High dose of bel-sar + laser application
Low dose bel-sar treatment arm & laser application	Bel-sar	Low dose of bel-sar + laser application
Low dose bel-sar treatment arm & laser application	Suprachoroidal Microinjector	Low dose of bel-sar + laser application
Low dose bel-sar treatment arm & laser application	Infrared Laser	Low dose of bel-sar + laser application
Sham control arm & sham laser	Sham Infrared Laser	Sham injection + sham laser
Sham control arm & sham laser	Sham Microinjector	Sham injection + sham laser

Primary Outcome Measures

Name	Time	Method
Time to reach tumor progression	65 weeks	Tumor Progression

Secondary Outcome Measures

Name	Time	Method
Time to composite endpoint	65 weeks	Tumor progression or visual acuity failure

Trial Locations

Locations (58)

Retina Consultants of Alabama; 🇺🇸 Birmingham, Alabama, United States

UCSD Shiley Eye Institute, Jacobs Retina Center; 🇺🇸 La Jolla, California, United States

Doris Stein Eye Research Center; 🇺🇸 Los Angeles, California, United States

Stanford University School of Medicine; 🇺🇸 Palo Alto, California, United States

Retinal Consultants Medical Group, Inc.; 🇺🇸 Sacramento, California, United States

Bascom Palmer Eye Institute; 🇺🇸 Miami, Florida, United States

Retina Associates of Florida, PA; 🇺🇸 Tampa, Florida, United States

Emory Eye Center; 🇺🇸 Atlanta, Georgia, United States

University of Illinois at Chicago; 🇺🇸 Chicago, Illinois, United States

Tufts Medical Center New England Eye Center; 🇺🇸 Boston, Massachusetts, United States

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