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Virus Therapy

Belzupacap Sarotalocan for Eye Melanoma (CoMpass Trial)

Q: Has the federal regulatory body approved high dose bel-sar treatment arm and laser application?

<p>The safety of High dose bel-sar treatment arm &#x26; laser application was rated a 3. This is because the Phase 3 trial has gathered evidence demonstrating that this intervention is both effective and safe.</p>

Phase 3

Recruiting

Research Sponsored by Aura Biosciences

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Clinical diagnosis of primary indeterminate lesion or small choroidal melanoma (IL/CM)

Have no evidence of metastatic disease confirmed by imaging

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 52 weeks

Awards & highlights

CoMpass Trial Summary

This trial will compare the safety and effectiveness of a new drug to a sham treatment in patients with eye lesions or small eye melanomas.

Who is the study for?

This trial is for individuals with a clinical diagnosis of primary indeterminate lesions or small choroidal melanoma, who haven't had treatment for these conditions yet (except possibly PDT), and have no signs of the cancer spreading elsewhere in the body.Check my eligibility

What is being tested?

The study is testing the safety and effectiveness of a new treatment called belzupacap sarotalocan using a special microinjector and infrared laser. Participants will be randomly assigned to either receive this new treatment or a sham (fake) procedure that mimics it without any active drug.See study design

What are the potential side effects?

Potential side effects may include discomfort at the injection site, eye inflammation, vision changes, or other reactions related to the drug or laser treatment. The exact side effects are being studied as part of this trial.

CoMpass Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have been diagnosed with a small eye melanoma or an uncertain eye lesion.

Select...

My scans show no signs of cancer spread.

CoMpass Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 52 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~52 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 52 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Time to reach tumor progression

Secondary outcome measures

Time to composite endpoint

CoMpass Trial Design

3Treatment groups

Experimental Treatment

Placebo Group

Group I: Low dose bel-sar treatment arm & laser applicationExperimental Treatment3 Interventions

Low dose of bel-sar + laser application

Group II: High dose bel-sar treatment arm & laser applicationExperimental Treatment3 Interventions

High dose of bel-sar + laser application

Group III: Sham control arm & sham laserPlacebo Group3 Interventions

Sham dose + sham laser

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Infrared Laser

2018

N/A

~10

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Aura BiosciencesLead Sponsor

5 Previous Clinical Trials

602 Total Patients Enrolled

1 Trials studying Indeterminate Lesions

2 Patients Enrolled for Indeterminate Lesions

Medical MonitorStudy DirectorAura Biosciences

1,660 Previous Clinical Trials

983,729 Total Patients Enrolled

1 Trials studying Indeterminate Lesions

2 Patients Enrolled for Indeterminate Lesions

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this clinical research project currently have open enrollment?

"According to clinicaltrials.gov, this medical trial is currently in search of patients; it was initially posted on September 30th 2023 and updated for the last time on August 23rd 2023."

Answered by AI

To what extent is this clinical trial being implemented and how many individuals are taking part?

"Aura Biosciences are looking to enrol 100 suitable patients for their trial. The research is being conducted at the UCSD Shiley Eye Institute, Jacobs Retina Center in La Jolla and Retinal Consultants Medical Group Inc. located in Sacramento, Florida."

Answered by AI

Are there various venues in the US where this experiment is being conducted?

"Prospective participants can join this trial at a variety of sites, including the UCSD Shiley Eye Institute, Jacobs Retina Center in La Jolla, California; Retinal Consultants Medical Group Inc. in Sacramento, Florida; and Retina Associates of Florida PA located in Tampa, Georgia. An additional 33 locations are also available for enrollment."

Answered by AI

Has the federal regulatory body approved high dose bel-sar treatment arm and laser application?

"The safety of High dose bel-sar treatment arm & laser application was rated a 3. This is because the Phase 3 trial has gathered evidence demonstrating that this intervention is both effective and safe."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2023. "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". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06007690.

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