Suprachoroidal Administration in Subjects With Metastases to the Choroid

Phase 2

Recruiting

• Conditions: Primary Cancer; Eye Cancer
• Interventions: Drug: AU-011; Device: SCS Microinjector; Device: Laser

• Registration Number: NCT06643884
• Lead Sponsor: Aura Biosciences

Brief Summary

The primary objective is to assess the safety and tolerability of bel-sar treatment in subjects with metastases to the choroid from any primary carcinoma.

Detailed Description

This is an open-label, dose escalation trial designed to assess safety and tolerability of 4 dose strengths and 1-2 cycles of bel-sar treatment in subjects with metastases to the choroid from any primary carcinoma.

Study Timeline

• Study First Submitted: 2024-10-14
• Study First Submitted QC: 2024-10-14
• Study First Posted: 2024-10-16
• Study Start: 2024-12-16
• Status Verified: 2025-09
• Last Update Submitted: 2025-09-26
• Last Update Posted: 2025-10-01
• Primary Completion: 2026-03-31
• Study Completion: 2027-02-28

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

• Have a clinical diagnosis of Metastases to the Choroid, from a histopathologically or cytologically confirmed tumor.
• Have at least one Metastases to the Choroid in the study eye

Exclusion Criteria

• Active ocular infection or disease.
• Must not have evidence of a primary tumor or metastatic lesion in the brain requiring treatment with radiation therapy per the primary treating oncologist's assessment.
• Must not be planning or expecting to switch/add systemic antineoplastic therapies during treatment

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
80 micrograms of bel-sar	AU-011	1 Cycle AU-011 with a dose of 80 micrograms
80 micrograms of bel-sar	SCS Microinjector	1 Cycle AU-011 with a dose of 80 micrograms
80 micrograms of bel-sar	Laser	1 Cycle AU-011 with a dose of 80 micrograms
140 micrograms of bel-sar	AU-011	1 Cycle AU-011 with a dose of 160 micrograms
140 micrograms of bel-sar	SCS Microinjector	1 Cycle AU-011 with a dose of 160 micrograms
140 micrograms of bel-sar	Laser	1 Cycle AU-011 with a dose of 160 micrograms
200 micrograms of bel-sar with one cycle	AU-011	1 Cycle AU-011 with a dose of 200 micrograms
200 micrograms of bel-sar with one cycle	SCS Microinjector	1 Cycle AU-011 with a dose of 200 micrograms
200 micrograms of bel-sar with one cycle	Laser	1 Cycle AU-011 with a dose of 200 micrograms
200 micrograms of bel-sar with two cycles	AU-011	2 Cycles AU-011 with a dose of 200 micrograms
200 micrograms of bel-sar with two cycles	SCS Microinjector	2 Cycles AU-011 with a dose of 200 micrograms
200 micrograms of bel-sar with two cycles	Laser	2 Cycles AU-011 with a dose of 200 micrograms

Primary Outcome Measures

Name	Time	Method
Change from baseline in choroidal tumor thickness on B-scan ultrasonography (B-scan) 4 weeks after completion of treatment.	4 weeks after completion of treatment	B-Scan Ultrasonography
Change from baseline in choroidal tumor largest basal diameter (LBD) on fundus photos 4 weeks after completion of treatment.	4 weeks after completion of treatment	Fundus photos

Trial Locations

Locations (9)

Shields and Shields, PC; 🇺🇸 Philadelphia, Pennsylvania, United States

Byers Eye Institute at Stanford University; 🇺🇸 Palo Alto, California, United States

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

Massachusetts Eye and Ear; 🇺🇸 Boston, Massachusetts, United States

Kellogg Eye Center; 🇺🇸 Ann Arbor, Michigan, United States

Cleveland Clinic, Cole Eye Institute; 🇺🇸 Cleveland, Ohio, United States

Tennessee Retina, PC; 🇺🇸 Nashville, Tennessee, United States

Retina Consultants of Texas; 🇺🇸 Bellaire, Texas, United States

University of Washington; 🇺🇸 Seattle, Washington, United States