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Recruiting NCT06643884

Suprachoroidal Administration in Subjects With Metastases to the Choroid

Phase II Interventional Eye Cancer Primary Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: AU-011, SCS Microinjector, Laser.
Who it may be relevant to
Registry conditions: Eye Cancer, Primary Cancer. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Phase 2, Open-Label, Dose Escalation Trial Assessing the Safety, Tolerability, and Treatment Effect of Belzupacap Sarotalocan (AU-011) With Suprachoroidal Administration in Subjects With Metastases to the Choroid

Overview

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.

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.

Interventions

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

Primary outcome measures

  • 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Sequential
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 10 centers
  • Byers Eye Institute at Stanford University — Palo Alto
  • Bascom Palmer Eye Institute — Miami
  • Massachusetts Eye and Ear — Boston
  • Kellogg Eye Center — Ann Arbor
  • Mayo Clinic — Rochester
  • Cleveland Clinic, Cole Eye Institute — Cleveland
  • Shields and Shields, PC — Philadelphia
  • Tennessee Retina, PC — Nashville
  • … and 2 more centers

Identifiers

NCT: NCT06643884 · AU-011-203

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗