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The trial is taking place at:
A

Austin Retina Associates | Main | Austin, TX

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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 (CoMpass)

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Aura Biosciences

Status and phase

Enrolling
Phase 3

Conditions

Indeterminate Lesions
Ocular Melanoma
Choroidal Melanoma
Uveal Melanoma

Treatments

Device: Suprachoroidal Microinjector
Drug: Sham Treatment
Device: Infrared Laser
Device: Sham Infrared Laser
Device: Sham Microinjector
Drug: Belzupacap Sarotalocan

Study type

Interventional

Funder types

Industry

Identifiers

NCT06007690
AU-011-301

Details and patient eligibility

About

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).

Full description

This is a randomized, sham-controlled, subject-, assessor-, and Sponsor- masked trial to establish the safety and efficacy of bel-sar treatment via suprachoroidal (SC) administration in subjects with primary IL/CM. Bel-sar treatment incorporates administration of bel-sar drug product using a suprachoroidal space (SCS) microinjector and activation of bel-sar by a laser photoactivation device.

Enrollment

100 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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 or sensitivities to the study drug or laser
  • Active ocular infection or disease

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

100 participants in 3 patient groups

High dose bel-sar treatment arm & laser application
Experimental group
Description:
High dose of bel-sar + laser application
Treatment:
Drug: Belzupacap Sarotalocan
Device: Infrared Laser
Device: Suprachoroidal Microinjector
Low dose bel-sar treatment arm & laser application
Experimental group
Description:
Low dose of bel-sar + laser application
Treatment:
Drug: Belzupacap Sarotalocan
Device: Infrared Laser
Device: Suprachoroidal Microinjector
Sham control arm & sham laser
Sham Comparator group
Description:
Sham dose + sham laser
Treatment:
Device: Sham Microinjector
Device: Sham Infrared Laser
Drug: Sham Treatment

Trial contacts and locations

38

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Central trial contact

Medical Monitor

Data sourced from clinicaltrials.gov

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