This study is in progress, not accepting new patients

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

a study on Skin Cancer/Melanoma Indeterminate Lesions Ocular Melanoma Eye Cancer

Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCLA UCSD
Dates
study started
study ends around

Description

Summary

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).

Details

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.

Keywords

Choroidal Melanoma, Indeterminate Lesions, Uveal Melanoma, Ocular Melanoma, Eye Cancer, Eye Neoplasms, Bel-sar, Suprachoroidal Microinjector, Infrared Laser

Eligibility

You can join if…

Open to people ages 18 years and up

You CAN'T join if...

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

Locations

  • UCSD Shiley Eye Institute, Jacobs Retina Center
    La Jolla California 92093 United States
  • Doris Stein Eye Research Center
    Los Angeles California 90095 United States
  • Retinal Consultants Medical Group, Inc.
    Sacramento California 95825 United States
  • Stanford University School of Medicine
    Palo Alto California 94303 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Aura Biosciences
Links
Aura Biosciences
ID
NCT06007690
Phase
Phase 3 research study
Study Type
Interventional
Participants
About 108 people participating
Last Updated