Recruiting
Phase 2

Bel-Sar

Sponsor:

Aura Biosciences

Code:

NCT06643884

Conditions

Eye Cancer

Primary Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

AU-011

SCS Microinjector

Laser

Study Details

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 solid tumor.

Conditions

Eye Cancer

Primary Cancer

Study ID

NCT06643884

Start date

Dec 16, 2024

Status verified date

Mar, 2026

Completion date

Oct 31, 2027

Anticipated

Primary completion date

Nov 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

24 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 80 micrograms of bel-sar

1 Cycle AU-011 with a dose of 80 micrograms

experimental: 140 micrograms of bel-sar

1 Cycle AU-011 with a dose of 140 micrograms

experimental: 200 micrograms of bel-sar with one cycle

1 Cycle AU-011 with a dose of 200 micrograms

experimental: 200 micrograms of bel-sar with two cycles

2 Cycles AU-011 with a dose of 200 micrograms

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

experimental: 40 micrograms of bel-sar with two cycles

2 Cycles AU-011 with a dose of 40 micrograms

Interventions

AU-011

AU-011 Via Suprachoroidal Administration with laser treatment

SCS Microinjector

Suprachoroidal Injection Device

Laser

Laser Administration

Primary outcome measure

  • Change from baseline in choroidal tumor thickness on B-scan ultrasonography (B-scan) 4 weeks after completion of treatment. [ Time Frame: 4 weeks after completion of treatment ]
  • Change from baseline in choroidal tumor largest basal diameter (LBD) on fundus photos 4 weeks after completion of treatment. [ Time Frame: 4 weeks after completion of treatment ]

Central Contacts and Locations

Central contacts

Medical Monitor

617-500-8864clinical@aurabiosciences.com

Locations

Byers Eye Institute at Stanford University

Recruiting

Palo Alto, California, United States, 94303

Bascom Palmer Eye Institute

Recruiting

Miami, Florida, United States, 33136

Massachusetts Eye and Ear

Recruiting

Boston, Massachusetts, United States, 02114

Kellogg Eye Center

Recruiting

Ann Arbor, Michigan, United States, 48105

Tennessee Retina, PC

Recruiting

Nashville, Tennessee, United States, 37203

Retina Consultants of Texas

Recruiting

Bellaire, Texas, United States, 77401

University of Washington

Recruiting

Seattle, Washington, United States, 98104

More Information

Sponsor

Aura Biosciences

Last update posted

Mar 13, 2026

Last verified

Mar, 2026

Keywords

  • Choroidal Metastasis
  • Metastases to the Choroid
  • ocular
  • eye

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Aura Biosciences on 2026-03-13.