Long-term follow-up study to AU-011-301 study
Research type
Research Study
Full title
A Long-Term Follow-Up Study of Subjects Completing the AU-011-301 (CoMpass) Trial of Bel-sar for Early Choroidal Melanoma (Indeterminate Lesions/Small Choroidal Melanomas)
IRAS ID
1013769
Contact name
Alena Chekmasova
Sponsor organisation
Aura Biosciences, Inc.
Clinicaltrials.gov Identifier
Research summary
Choroidal melanoma is a type of eye cancer. Indeterminate lesions are changes in the eye that may develop into melanoma. People with these conditions are usually treated with radiation therapy, surgery (removal of the eye), or careful monitoring.
Aura Biosciences, Inc. is developing an investigational treatment called belzupacap sarotalocan (bel-sar). This treatment is injected into the eye and then activated with a laser to target cancer cells while limiting damage to healthy tissue.
This study is a long-term follow-up study for people who previously took part in the AU-011-301 (CoMpass) study, where they received either bel-sar or a sham (placebo) procedure. The aim of this study is to understand the long-term safety and effectiveness of bel-sar over time. No treatment will be given as part of this study.
Participants will attend study visits approximately every 6 months for up to 5 years. During these visits, eye examinations and scans will be performed to monitor vision, tumour changes, and any side effects. Participants will also complete questionnaires about their quality of life.
If the cancer shows signs of progression, participants will receive standard medical care as decided by their doctor.
The study will include approximately 100 participants worldwide.REC name
Wales REC 2
REC reference
26/WA/0128
Date of REC Opinion
11 Jun 2026
REC opinion
Further Information Favourable Opinion