Suprachoroidal bel‑sar (AU‑011) for metastases in the choroid

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is an open‑label, Phase 2 dose‑escalation trial testing four dose levels of bel‑sar (AU‑011) delivered suprachoroidally using a microinjector, with adjunct laser as specified in the protocol. Participants will receive one to two treatment cycles and be monitored for safety, ocular tolerability, and adverse events. Subjects must have at least one histologically or cytologically confirmed metastasis to the choroid in the treated eye and no active ocular infection or brain metastases requiring radiation. The trial is being conducted at three US academic ophthalmology centers and focuses on local delivery to limit systemic exposure.

Why it matters

Who can join: the full rules

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 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

Where it's running

• Byers Eye Institute at Stanford University
  Palo Alto, California, United States Recruiting
• Bascom Palmer Eye Institute
  Miami, Florida, United States Recruiting
• Massachusetts Eye and Ear
  Boston, Massachusetts, United States Recruiting
• Kellogg Eye Center
  Ann Arbor, Michigan, United States Recruiting
• Cleveland Clinic, Cole Eye Institute
  Cleveland, Ohio, United States Recruiting
• Tennessee Retina, PC
  Nashville, Tennessee, United States Recruiting

Study contacts

• Study coordinator: Medical Monitor
• Email: clinical@aurabiosciences.com
• Phone: 617-500-8864

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.