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Suprachoroidal Administration in Subjects With Metastases to the Choroid

  • PhasePhase 2
  • StatusRecruiting
  • Planned enrollment24 people
  • Recruiting US sites8
  • SponsorAura Biosciences
  • RegistryNCT06643884

Recruitment re-checked on ClinicalTrials.gov Oct 30, 2026. Public record; not medical advice.

Suprachoroidal Administration in Subjects With Metastases to the Choroid: a one-minute explainerNCT066438841 min

Eligibility

Who can join

The film gives the main points. The full list below is copied from the registry; the study team makes the final decision.

  • Age18 Years to no maximum
  • SexAll
  • Healthy volunteersNo

You may be able to join 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 cannot join 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 where placement of the beam is likely to impact the study eye.
  • Must not be planning or expecting to switch/add systemic antineoplastic therapies during treatment

The treatment

How it is intended to work

This is how the treatment is meant to work. Whether it helps, and how safe it is, is what this trial is testing.

belzupacap sarotalocan. A formulation composed of nanoparticles derived from the human papillomavirus (HPV-NPs) and conjugated to the infrared (IR)-activated fluorescent dye IR700 (IR-700), with potential antineoplastic activity. Upon intravitreal injection of belzupacap sarotalocan, the HPV-NPs target and bind to heparan-sulfated proteoglycans (HSPG) expressed by ocular melanoma cells. Upon irradiation with near-IR (NIR) light, the photosensitizer IR700 becomes activated, generates reactive oxygen species (ROS) and selectively damages the melanoma cell membrane, which induces necrosis of the melanoma cells while sparing the surrounding, healthy non-HSPG-expressing tissue, and potentially preserving vision. HSPGs are overexpressed on a variety of cancer cell types. NCI Drug Dictionary

Treatments listed in the registry

  • AU-011 (Drug): AU-011 Via Suprachoroidal Administration with laser treatment
  • SCS Microinjector (Device): Suprachoroidal Injection Device
  • Laser (Device): Laser Administration

The study

Treatment groups

Non Randomized · Sequential · masking: None

80 micrograms of bel-sar (Experimental)

1 Cycle AU-011 with a dose of 80 micrograms

140 micrograms of bel-sar (Experimental)

1 Cycle AU-011 with a dose of 140 micrograms

200 micrograms of bel-sar with one cycle (Experimental)

1 Cycle AU-011 with a dose of 200 micrograms

200 micrograms of bel-sar with two cycles (Experimental)

2 Cycles AU-011 with a dose of 200 micrograms

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

40 micrograms of bel-sar with two cycles (Experimental)

2 Cycles AU-011 with a dose of 40 micrograms

Goals

What the study measures

Main goals

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

Planned enrollment: 24 (estimated).

Where

Recruiting US sites

  • Byers Eye Institute at Stanford University, Palo Alto, California
  • Bascom Palmer Eye Institute, Miami, Florida
  • Massachusetts Eye and Ear, Boston, Massachusetts
  • Kellogg Eye Center, Ann Arbor, Michigan
  • Cleveland Clinic, Cole Eye Institute, Cleveland, Ohio
  • Tennessee Retina, PC, Nashville, Tennessee
  • Retina Consultants of Texas, Bellaire, Texas
  • University of Washington, Seattle, Washington

Site status as of Oct 30, 2026. Check the live record before contacting a site.

Sources

Where this comes from

Registry record reviewed as fetched Oct 30, 2026, last updated by the sponsor Oct 7, 2026. Public record; not medical advice.

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