Trials Today

Suprachoroidal Administration in Subjects With Metastases to the Choroid

Purpose

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.

Conditions

Eye Cancer
Primary Cancer

Eligibility

Eligible Ages: Over 18 Years
Eligible Sex: All
Accepts Healthy Volunteers: No

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

Phase: Phase 2
Study Type: Interventional
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Primary Purpose: Treatment
Masking: None (Open Label)

Arm Groups

Arm	Description	Assigned Intervention
Experimental 80 micrograms of bel-sar	1 Cycle AU-011 with a dose of 80 micrograms	Drug: AU-011 AU-011 Via Suprachoroidal Administration with laser treatment Device: SCS Microinjector Suprachoroidal Injection Device Device: Laser Laser Administration
Experimental 140 micrograms of bel-sar	1 Cycle AU-011 with a dose of 140 micrograms	Drug: AU-011 AU-011 Via Suprachoroidal Administration with laser treatment Device: SCS Microinjector Suprachoroidal Injection Device Device: Laser Laser Administration
Experimental 200 micrograms of bel-sar with one cycle	1 Cycle AU-011 with a dose of 200 micrograms	Drug: AU-011 AU-011 Via Suprachoroidal Administration with laser treatment Device: SCS Microinjector Suprachoroidal Injection Device Device: Laser Laser Administration
Experimental 200 micrograms of bel-sar with two cycles	2 Cycles AU-011 with a dose of 200 micrograms	Drug: AU-011 AU-011 Via Suprachoroidal Administration with laser treatment Device: SCS Microinjector Suprachoroidal Injection Device Device: Laser Laser Administration
No Intervention Observational	Subjects that meet trial inclusion, but do not meet criteria for enrollment into the bel-sar treatment cohorts, may be enrolled in this cohort. The observational cohort will not receive bel-sar treatment.
Experimental 40 micrograms of bel-sar with one cycle	1 Cycle AU-011 with a dose of 40 micrograms	Drug: AU-011 AU-011 Via Suprachoroidal Administration with laser treatment Device: SCS Microinjector Suprachoroidal Injection Device Device: Laser Laser Administration
Experimental 40 micrograms of bel-sar with two cycles	2 Cycles AU-011 with a dose of 40 micrograms	Drug: AU-011 AU-011 Via Suprachoroidal Administration with laser treatment Device: SCS Microinjector Suprachoroidal Injection Device Device: Laser Laser Administration

Recruiting Locations

Byers Eye Institute at Stanford University
Palo Alto, California 94303

Bascom Palmer Eye Institute
Miami, Florida 33136

Massachusetts Eye and Ear
Boston, Massachusetts 02114

Kellogg Eye Center
Ann Arbor, Michigan 48105

Tennessee Retina, PC
Nashville, Tennessee 37203

Retina Consultants of Texas
Bellaire, Texas 77401

University of Washington
Seattle, Washington 98104

More Details

NCT ID: NCT06643884
Status: Recruiting
Sponsor: Aura Biosciences

Study Contact

Medical Monitor
617-500-8864
clinical@aurabiosciences.com

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.