A Phase 3 Randomized, Masked, Controlled Trial to Evaluate Efficacy and Safety of Belzupacap Sarotalocan (AU-011) Treatment Compared to Sham Control in Subjects with Primary Indeterminate Lesions or Small Choroidal Melanoma

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-504655-27-00

Acronym

AU-011-301

Enrollment

142

Registered

2024-05-20

Start date

2024-12-23

Completion date

Unknown

Last updated

2025-11-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary Indeterminate Lesions or Small Choroidal Melanoma

Brief summary

Time to reach Tumor Progression (at the Week 65 analysis).

Detailed description

Time to reach the Composite Endpoint (at the Week 65 analysis). • Tumor progression or visual acuity failure

Interventions

DRUGPlacebo (Sham injection) to Belzupacap Sarotalocan solution for sham injection 0.0 mg/mL

DRUGBELZUPACAP SAROTALOCAN

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Time to reach Tumor Progression (at the Week 65 analysis).	—

Secondary

Measure	Time frame
Time to reach the Composite Endpoint (at the Week 65 analysis). • Tumor progression or visual acuity failure	—

Countries

Austria, Belgium, Czechia, Denmark, France, Germany, Greece, Ireland, Italy, Netherlands, Spain, Sweden

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026