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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

ConditionsChoroidal MelanomaIndeterminate LesionsUveal MelanomaOcular Melanoma
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorAura Biosciences

About this trial

The primary objective is to determine the safety and efficacy of belzupacap sarotalocan (bel-sar) compared to sham control in patients with primary indeterminate lesions (IL) or small choroidal melanoma (CM).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

Have known contraindications or sensitivities to the study drug or laser

Active ocular infection or disease

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

100 Participants
are divided into 3 treatment groups
Group A: High dose bel-sar treatment arm & laser applicationExperimental treatment 3 interventions
Group B: Low dose bel-sar treatment arm & laser applicationExperimental treatment 3 interventions
Group C: Sham control arm & sham laserSham comparator 2 interventions

Trial outcomes

Primary outcomes

1

Time to reach tumor progression

Tumor Progression

Time frame
65 weeks

Secondary outcomes

1

Time to composite endpoint

Tumor progression or visual acuity failure

Time frame
65 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Aura Biosciences

Lead sponsor

Source ClinicalTrials.gov
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