Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06007690 | 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 | PHASE3 | RECRUITING | 100 | — | — | Dec 6, 2023 | Aug 15, 2028 | Mar 2, 2026 | 71 | United States, Australia +12 |
Tumor Progression
| Arm | Type | Description |
|---|---|---|
| High dose bel-sar treatment arm & laser application | EXPERIMENTAL | High dose of bel-sar + laser application |
| Low dose bel-sar treatment arm & laser application | EXPERIMENTAL | Low dose of bel-sar + laser application |
| Sham control arm & sham laser | SHAM_COMPARATOR | Sham injection + sham laser |
| Name | Type | Description |
|---|---|---|
| Bel-sar | DRUG | Bel-sar via suprachoroidal administration followed by laser application. |
| Suprachoroidal Microinjector | DEVICE | Suprachoroidal injection device |
| Infrared Laser | DEVICE | Laser application |
| Sham Infrared Laser | DEVICE | Sham laser application |
| Sham Microinjector | DEVICE | Sham injection device |
Inclusion Criteria: * Clinical diagnosis of primary indeterminate lesion or small choroidal melanoma (IL/CM) * Have no evidence of metastatic disease confirmed by imaging * Be treatment naive for IL/CM (subjects who received PDT may be eligible) Exclusion Criteria: * Have known contraindications ...