CClinicalTrials.gg
RecruitingNCT06643884Updated Mar 13, 2026

Suprachoroidal Administration in Subjects With Metastases to the Choroid

A Phase 2 interventional study of AU-011 and SCS Microinjector in Eye Cancer and Primary Cancer, sponsored by Aura Biosciences. Recruiting at 10 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-13.

Sponsored by Aura Biosciences · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Started Dec 2024; still recruiting 1 year 9 months later.
Phase
Phase 2
Study type
Interventional
Enrollment
24
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

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.

Read the 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.

02

Conditions studied

  • Eye Cancer
  • Primary Cancer

Keywords

  • Choroidal Metastasis
  • Metastases to the Choroid
  • ocular
  • eye
03

In context

Eye Neoplasms

26 studies on the registry are indexed under Eye Neoplasms; 6 are open to participants now.

This study's planned enrollment of 24 is below the median of 40 across 15 interventional studies indexed under Eye Neoplasms.

Browse Eye Neoplasms studies →

Lead sponsor

Aura Biosciences is the lead sponsor of 9 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
24 participants (estimated)

Study arms

  • Experimental
    80 micrograms of bel-sar

    1 Cycle AU-011 with a dose of 80 micrograms

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

  • Experimental
    140 micrograms of bel-sar

    1 Cycle AU-011 with a dose of 140 micrograms

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

  • Experimental
    200 micrograms of bel-sar with one cycle

    1 Cycle AU-011 with a dose of 200 micrograms

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

  • Experimental
    200 micrograms of bel-sar with two cycles

    2 Cycles AU-011 with a dose of 200 micrograms

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

  • 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 · Device: SCS Microinjector · Device: Laser

  • Experimental
    40 micrograms of bel-sar with two cycles

    2 Cycles AU-011 with a dose of 40 micrograms

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

Interventions

  • DrugAU-011

    AU-011 Via Suprachoroidal Administration with laser treatment

  • DeviceSCS Microinjector

    Suprachoroidal Injection Device

  • DeviceLaser

    Laser Administration

06

What researchers measure

Primary outcomes

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

    B-Scan Ultrasonography

    Time frame: 4 weeks after completion of treatment

  2. Change from baseline in choroidal tumor largest basal diameter (LBD) on fundus photos 4 weeks after completion of treatment.

    Fundus photos

    Time frame: 4 weeks after completion of treatment

07

Study locations

7 of 10 sites recruiting
  • 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
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 13, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06643884
Lead sponsor
Aura Biosciences
Responsible party
Sponsor
First posted
Oct 16, 2024
Start date
Dec 16, 2024
Primary completion
Nov 30, 2026 (estimated)
Completion
Oct 31, 2027 (estimated)
Last update
Mar 13, 2026

Study contacts

Medical Monitor
Contact
clinical@aurabiosciences.com
617-500-8864
Medical Monitor
study director · Aura Biosciences

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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