Suprachoroidal Administration in Subjects With Metastases to the Choroid

NCT06643884 | Recruiting Phase 2 DMC FDA Drug FDA Device

• 1 other identifier: AU-011-203
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 10

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

Keywords

Choroidal Metastasis; Metastases to the Choroid; ocular; eye

Outcome Measures

Primary Outcomes (2)

• Change from baseline in choroidal tumor thickness on B-scan ultrasonography (B-scan) 4 weeks after completion of treatment.

  B-Scan Ultrasonography

  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.

  Fundus photos

  4 weeks after completion of treatment

Study Arms (7)

80 micrograms of bel-sar

EXPERIMENTAL

1 Cycle AU-011 with a dose of 80 micrograms

Drug: AU-011; Device: SCS Microinjector; Device: Laser

140 micrograms of bel-sar

EXPERIMENTAL

1 Cycle AU-011 with a dose of 140 micrograms

Drug: AU-011; Device: SCS Microinjector; Device: Laser

200 micrograms of bel-sar with one cycle

EXPERIMENTAL

1 Cycle AU-011 with a dose of 200 micrograms

Drug: AU-011; Device: SCS Microinjector; Device: Laser

200 micrograms of bel-sar with two cycles

EXPERIMENTAL

2 Cycles AU-011 with a dose of 200 micrograms

Drug: AU-011; Device: SCS Microinjector; Device: Laser

Observational

NO INTERVENTION

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.

40 micrograms of bel-sar with one cycle

EXPERIMENTAL

1 Cycle AU-011 with a dose of 40 micrograms

Drug: AU-011; Device: SCS Microinjector; Device: Laser

40 micrograms of bel-sar with two cycles

EXPERIMENTAL

2 Cycles AU-011 with a dose of 40 micrograms

Drug: AU-011; Device: SCS Microinjector; Device: Laser

Interventions

AU-011 DRUG

AU-011 Via Suprachoroidal Administration with laser treatment

140 micrograms of bel-sar; 200 micrograms of bel-sar with one cycle; 200 micrograms of bel-sar with two cycles; 40 micrograms of bel-sar with one cycle; 40 micrograms of bel-sar with two cycles; 80 micrograms of bel-sar

SCS Microinjector DEVICE

Suprachoroidal Injection Device

140 micrograms of bel-sar; 200 micrograms of bel-sar with one cycle; 200 micrograms of bel-sar with two cycles; 40 micrograms of bel-sar with one cycle; 40 micrograms of bel-sar with two cycles; 80 micrograms of bel-sar

Laser DEVICE

Laser Administration

140 micrograms of bel-sar; 200 micrograms of bel-sar with one cycle; 200 micrograms of bel-sar with two cycles; 40 micrograms of bel-sar with one cycle; 40 micrograms of bel-sar with two cycles; 80 micrograms of bel-sar

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Aura Biosciences: lead

Study Sites (10)

Byers Eye Institute at Stanford University

Palo Alto, California, 94303, United States

RECRUITING

Bascom Palmer Eye Institute

Miami, Florida, 33136, United States

RECRUITING

Massachusetts Eye and Ear

Boston, Massachusetts, 02114, United States

RECRUITING

Kellogg Eye Center

Ann Arbor, Michigan, 48105, United States

RECRUITING

Mayo Clinic

Rochester, Minnesota, 55905, United States

NOT YET RECRUITING

Cleveland Clinic, Cole Eye Institute

Cleveland, Ohio, 44195, United States

NOT YET RECRUITING

Shields and Shields, PC

Philadelphia, Pennsylvania, 19107, United States

NOT YET RECRUITING

Tennessee Retina, PC

Nashville, Tennessee, 37203, United States

RECRUITING

Retina Consultants of Texas

Bellaire, Texas, 77401, United States

RECRUITING

University of Washington

Seattle, Washington, 98104, United States

RECRUITING

MeSH Terms

Conditions

Eye Neoplasms; Neoplasms

Interventions

Lasers

Condition Hierarchy (Ancestors)

Neoplasms by Site; Eye Diseases

Intervention Hierarchy (Ancestors)

Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies

Study Officials

• Medical Monitor

  Aura Biosciences

  STUDY DIRECTOR

Central Study Contacts

Medical Monitor

CONTACT

617-500-8864; clinical@aurabiosciences.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 14, 2024
• First Posted: October 16, 2024
• Study Start: December 16, 2024
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): October 31, 2027
• Last Updated: March 13, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (10)