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Clinical trials
catalyst calendar across sponsors →Studies where AURA is the lead sponsor, as filed with ClinicalTrials.gov. Completion dates are the sponsor's own projected windows and are revised as a study runs. Active studies first, then completed and stopped — newest readout first within each.
5 interventional · 4 observational · 1 with posted results
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| Study | Phase | Status | Interventions | Conditions | Enrollment | Primary completion | Readout in | Updated |
|---|---|---|---|---|---|---|---|---|
| A Long-Term Follow-Up Study of Subjects Completing the AU-011-301(CoMpass) for Early Choroidal MelanomaNCT07338968observationalIncidence of adverse events (AEs)/serious AEs. | — | Enrolling by invitation | Other: Observational | Choroidal Melanoma, Indeterminate Lesions | 100 | 2033-08-15 | in 2,552 d | 2026-08-19 |
| A Registry of Subjects With Primary Indeterminate Lesions or Choroidal MelanomaNCT03941379observationalIncidence of Adverse Events and Serious Adverse Events that are related to IL/CM treatment with bel-sar. | — | Active, not recruiting | — | Choroidal Melanoma, Indeterminate Lesions of Eye | 63 | Dec 2028 | ≤ 864 d | 2026-05-22 |
| Choroidal Melanoma Patient-Reported Outcome Study (CM-PRO) in a Subset of AU-011-301 (CoMpass) SubjectsNCT07421739observationalChange from baseline in EORTC QLQ-C30 scores at month 15 and 24. | — | Recruiting | Other: Non-interventional, digital, patient-reported, real-world study | Choroidal Melanoma, Indeterminate Lesions, Uveal Melanoma, Ocular Melanoma | 15 | 2028-08-15 | in 726 d | 2026-02-19 |
| 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 MelanomaNCT06007690Time to reach tumor progressionRandomized · Double-masked · Treatment | Phase 3 | Active, not recruiting | Drug: Bel-sar · Device: Suprachoroidal Microinjector, Infrared Laser, Sham Infrared Laser, Sham Microinjector | Choroidal Melanoma, Indeterminate Lesions, Uveal Melanoma, Ocular Melanoma | 108 | 2027-11-15 | in 452 d | 2026-07-31 |
| A Phase 1, Open-label Trial of Belzupacap Sarotalocan (AU-011) in Bladder CancerNCT05483868Safety of AU-011: Incidences of SAEs and DLTsNon-randomized · Open-label · Treatment | Phase 1 | Active, not recruiting | Drug: AU-011 · Combination product: AU-011 in Combination with Medical Laser Adminstration, AU-011 in Combination with Medical Laser Administration | Non-muscle-invasive Bladder Cancer, NMIBC, Non-Muscle Invasive Bladder Carcinoma, Non-Muscle Invasive Bladder Neoplasms, Non-Muscle Invasive Bladder Urothelial Carcinoma, Urothelial Carcinoma Bladder | 55 | Mar 2027 | ≤ 223 d | 2026-08-06 |
| Suprachoroidal Administration in Subjects With Metastases to the ChoroidNCT06643884Change from baseline in choroidal tumor thickness on B-scan ultrasonography (B-scan) 4 weeks after completion of treatment.Non-randomized · Open-label · Treatment | Phase 2 | Recruiting | Drug: AU-011 · Device: SCS Microinjector, Laser | Eye Cancer, Primary Cancer | 24 | 2026-11-30 | in 102 d | 2026-03-13 |
| Phase 2 Trial to Evaluate Belzupacap Sarotalocan (AU-011) Via Suprachoroidal Administration in Subjects With Primary Indeterminate Lesions and Small Choroidal MelanomaNCT04417530Treatment related AEs and treatment related serious adverse events (SAEs).Non-randomized · Open-label · Treatment | Phase 2 | Completed | Drug: AU-011 · Device: Suprachoroidal Microinjector, PDT Laser | Uveal Melanoma, Ocular Melanoma, Choroidal Melanoma | 22 | 2024-04-22actual | — | 2025-03-03 |
| Prospective Group-Matched Study With Belzupacap Sarotalocan (Bel-sar; AU-011) or Plaque Radiotherapy for Primary Indeterminate Lesions or Choroidal Melanoma (IL/ CM)NCT05266430observationalVisual Acuity | — | Terminatedsponsor's stated reason: Sponsor Decision - Low Enrollment | Other: Standard of Care · Drug: AU-011 | Choroidal Melanoma, Indeterminate Lesions | 2 | 2023-02-01actual | — | 2023-08-09 |
| Study in Subjects With Small Primary Choroidal MelanomaNCT03052127results2024-02-01Number of Participants With Treatment-Emergent Adverse Events [Safety and Tolerability] of Light-activated AU-011Non-randomized · Open-label · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 1/2 | Completed | Drug: Light-activated AU-011 · Device: Laser Activation | Uveal Melanoma, Ocular Melanoma, Choroidal Melanoma | 57 | 2021-01-26actual | — | 2024-02-01 |
Primary completion is the date the sponsor filed with the registry — their own projection, revised whenever they revise it, unless the row is marked actual.
Source: ClinicalTrials.gov, retrieved 2026-08-19