Suprachoroidal Administration in Subjects With Metastases to the Choroid

NCT06643884 · tracked via the Priya Life Science USA tracker

Sponsor

Aura Biosciences

Phase

Phase 2

Started

2024-12-16

Last updated

2026-03-13

Condition(s) studied

Eye CancerPrimary Cancer

Investigational drug(s) / intervention(s)

AU-011SCS MicroinjectorLaser

AU-011: AU-011 Via Suprachoroidal Administration with laser treatment

SCS Microinjector: Suprachoroidal Injection Device

Laser: Laser Administration

Study 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 solid tumor.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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

Primary outcome measure(s)

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 sites (10)

Facility	City	Region	Status
Byers Eye Institute at Stanford University	Palo Alto	California	Recruiting
Bascom Palmer Eye Institute	Miami	Florida	Recruiting
Massachusetts Eye and Ear	Boston	Massachusetts	Recruiting
Kellogg Eye Center	Ann Arbor	Michigan	Recruiting
Mayo Clinic	Rochester	Minnesota	Not Yet Recruiting
Cleveland Clinic, Cole Eye Institute	Cleveland	Ohio	Not Yet Recruiting
Shields and Shields, PC	Philadelphia	Pennsylvania	Not Yet Recruiting
Tennessee Retina, PC	Nashville	Tennessee	Recruiting
Retina Consultants of Texas	Bellaire	Texas	Recruiting
University of Washington	Seattle	Washington	Recruiting

More Aura Biosciences trials in the USA

A Registry of Subjects With Primary Indeterminate Lesions or Choroidal Melanoma Active, not recruiting

A Phase 1, Open-label Trial of Belzupacap Sarotalocan (AU-011) in Bladder Cancer Active, not recruiting

A Long-Term Follow-Up Study of Subjects Completing the AU-011-301(CoMpass) for Early Choroidal Melanoma Enrolling by invitation

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 Active, not recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06643884 on ClinicalTrials.gov ↗ ← All trials in the USA