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

Study Purpose

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).

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

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 Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06007690
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 3
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Aura Biosciences
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Medical Monitor
Principal Investigator Affiliation	Aura Biosciences
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Recruiting
Countries	Australia, Belgium, Canada, Czechia, France, Germany, Israel, Netherlands, New Zealand, Spain, United Kingdom, United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Choroidal Melanoma, Indeterminate Lesions, Uveal Melanoma, Ocular Melanoma
Study Website:	View Trial Website

Additional 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.

Arms & Interventions

Arms

Experimental: High dose bel-sar treatment arm & laser application

High dose of bel-sar + laser application

Experimental: Low dose bel-sar treatment arm & laser application

Low dose of bel-sar + laser application

Sham Comparator: Sham control arm & sham laser

Sham injection + sham laser

Interventions

Drug: - Bel-sar

Bel-sar via suprachoroidal administration followed by laser application.

Device: - Suprachoroidal Microinjector

Suprachoroidal injection device

Device: - Infrared Laser

Laser application

Device: - Sham Infrared Laser

Sham laser application

Device: - Sham Microinjector

Sham injection device

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Retina Consultants of Alabama, Birmingham 4049979, Alabama 4829764

Status

Recruiting

Address

Retina Consultants of Alabama

Birmingham 4049979, Alabama 4829764, 35233

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