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NCT06643884PHASE2Recruiting

Suprachoroidal Administration in Subjects With Metastases to the Choroid

Aura Biosciences

Start Date

12/16/2024

Completion Date

10/31/2027

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.

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 solid tumor.

Eligibility Criteria

Age Range: 18 years to No maximum

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

Interventions

DRUG

AU-011

DEVICE

SCS Microinjector

DEVICE

Laser

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Conditions

Eye CancerPrimary Cancer

Locations

Byers Eye Institute at Stanford University

Palo Alto, California 94303

United States

Bascom Palmer Eye Institute

Miami, Florida 33136

United States

Massachusetts Eye and Ear

Boston, Massachusetts 02114

United States

Kellogg Eye Center

Ann Arbor, Michigan 48105

United States

Mayo Clinic

Rochester, Minnesota 55905

United States

Cleveland Clinic, Cole Eye Institute

Cleveland, Ohio 44195

United States

Shields and Shields, PC

Philadelphia, Pennsylvania 19107

United States

Tennessee Retina, PC

Nashville, Tennessee 37203

United States

Retina Consultants of Texas

Bellaire, Texas 77401

United States

University of Washington

Seattle, Washington 98104

United States