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)

February 26, 2026 updated by: Aura Biosciences
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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed 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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Australia
    • Queensland
      • Brisbane, Queensland, Australia, 4000
        • Recruiting
        • Terrace Eye Centre
    • Victoria
      • East Melbourne, Victoria, Australia, 3002
        • Recruiting
        • Eye Research Australia
  • Austria
      • Graz, Austria, 8036
        • Recruiting
        • Medical University Graz
      • Vienna, Austria, 1090
        • Recruiting
        • Medizinische Universität Wien, Department of Ophthalmology and Optometry
  • Belgium
      • Brussels, Belgium
        • Recruiting
        • Cliniques universitaires Saint-Luc
      • Leuven, Belgium, 3000
        • Recruiting
        • UZ Leuven
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2V 4Y8
        • Recruiting
        • Serac Eye and Skin Care Centre
    • Quebec
      • Québec, Quebec, Canada, G1S 4L8
        • Recruiting
        • Centre Hospitalier de l'Université Laval
  • Czechia
      • Prague, Czechia, 16902
        • Recruiting
        • Ustredni vojenska nemocnice Vojenska fakultni nemocnice Praha
    • Krč
      • Prague, Krč, Czechia, 14059
        • Recruiting
        • Fakultni Thomayerova nemocnice
    • Plzenský Kraj
      • Pilsen, Plzenský Kraj, Czechia, 32300
        • Recruiting
        • Fakultni nemocnice Plzen
  • France
    • Cedex 1
      • Nice, Cedex 1, France, 06001
        • Recruiting
        • Centre Hospitalier Universitaire de Nice
    • Rhone
      • Lyon, Rhone, France, 69004
        • Recruiting
        • Hospices Civils de Lyon - Hôpital de La Croix Rousse - Hospital
  • Germany
      • Berlin, Germany, 12203
        • Recruiting
        • Charité - Universitätsmedizin Berlin KöR
      • Cologne, Germany, 50937
        • Not yet recruiting
        • University Hospital Cologne (AöR)
      • Essen, Germany, 45147
        • Recruiting
        • Universitätsmedizin Essen
      • Hamburg, Germany, 20246
        • Recruiting
        • Uniklinikum Hamburg Eppendorf
      • Lübeck, Germany, 23538
        • Recruiting
        • Universitätsklinikum Schleswig-Holstein Klinik für Augenheilkunde
      • München, Germany, 80336
        • Recruiting
        • Klinikum der LMU Muenchen
      • Tübingen, Germany, 72076
        • Recruiting
        • Universitätsklinikum Tübingen
  • Israel
    • Central District
      • Tel-Hashomer, Central District, Israel, 5262100
        • Recruiting
        • The Chaim Sheba Medical Center
    • Jerusalem
      • Jerusalem, Jerusalem, Israel, 9112001
        • Recruiting
        • Hadassah Medical Center, Ein-Karem
  • Italy
      • Florence, Italy, 50134
        • Recruiting
        • AOUC Azienda Ospedaliero-Universitaria Careggi
      • Milan, Italy, 20157
        • Recruiting
        • Ospedale Fatebenefratelli e Oftalmico, ASST Fatebenefratelli Sacco
      • Milan, Italy, 20133
        • Recruiting
        • Istituto Nazionale dei Tumori, Fondazione IRCCS
      • Roma, Italy, 00168
        • Recruiting
        • Universita'Cattolica Del Sacro Cuore - UNICATT
  • Netherlands
      • Leiden, Netherlands, 2333 ZE
        • Recruiting
        • Leids Universitair Medisch Centrum (LUMC)
      • Rotterdam, Netherlands, 3015AA
        • Recruiting
        • Erasmus MC
  • New Zealand
      • Auckland, New Zealand, 1050
        • Recruiting
        • Auckland Eye Ltd
  • Spain
      • Barcelona, Spain, 08907
        • Recruiting
        • Hospital Universitario de Bellvitge
      • Santiago de Compostela, Spain, 15706
        • Recruiting
        • Hospital Provincial de Conxo
      • Seville, Spain, 41009
        • Recruiting
        • Hospital Virgen Macarena
      • Valencia, Spain, 46026
        • Recruiting
        • Hospital Universitario y Politécnico La Fe
  • United Kingdom
      • London, United Kingdom, EC1V 2PD
        • Recruiting
        • Moorfields Eye Hospital NHS Foundation Trust
      • Sheffield, United Kingdom, S10 2JF
        • Recruiting
        • Nhs Foundation Trust - Royal Hallamshire Hospital
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • Withdrawn
        • Retina Consultants of Alabama
    • California
      • La Jolla, California, United States, 92093
        • Recruiting
        • UCSD Shiley Eye Institute, Jacobs Retina Center
      • Los Angeles, California, United States, 90095
        • Recruiting
        • Doris Stein Eye Research Center
      • Palo Alto, California, United States, 94303
        • Recruiting
        • Stanford University School of Medicine
      • Sacramento, California, United States, 95825
        • Recruiting
        • Retinal Consultants Medical Group, Inc.
    • Florida
      • Miami, Florida, United States, 33136
        • Withdrawn
        • Bascom Palmer Eye Institute
      • Tampa, Florida, United States, 33609
        • Recruiting
        • Retina Associates of Florida, PA
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Recruiting
        • Emory Eye Center
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Recruiting
        • University of Illinois at Chicago
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Recruiting
        • Massachusetts Eye and Ear
      • Boston, Massachusetts, United States, 02111
        • Recruiting
        • Tufts Medical Center New England Eye Center
    • Michigan
      • Ann Arbor, Michigan, United States, 48105
        • Recruiting
        • W.K. Kellogg Eye Center - University of Michigan
      • Royal Oak, Michigan, United States, 48073
        • Recruiting
        • Associated Retinal Consultants (ARC) P.C.
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Recruiting
        • Mayo Clinic
    • Missouri
      • St Louis, Missouri, United States, 63110
        • Recruiting
        • Washington University
    • Nebraska
      • Omaha, Nebraska, United States, 68105
        • Recruiting
        • Nebraska Medicine's Truhlsen Eye Institute
    • New York
      • New York, New York, United States, 10032
        • Recruiting
        • Columbia University Irving Medical Center
    • North Carolina
      • Durham, North Carolina, United States, 27705
        • Recruiting
        • Duke Eye Center
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Recruiting
        • Cole Eye Institute
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Recruiting
        • Dean McGee Eye Institute
      • Oklahoma City, Oklahoma, United States, 73112
        • Recruiting
        • Retina Consultants of Oklahoma
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Recruiting
        • Shields & Shields PC-Wills Eye Institute
    • South Carolina
      • Greenville, South Carolina, United States, 29605
        • Recruiting
        • Retina Consultants of Carolina
    • Tennessee
      • Chattanooga, Tennessee, United States, 37421
        • Recruiting
        • Southeastern Retina Associates
      • Nashville, Tennessee, United States, 37203
        • Recruiting
        • Tennessee Retina, PC
    • Texas
      • Austin, Texas, United States, 78705
        • Recruiting
        • Austin Retina Associates
      • Dallas, Texas, United States, 75231
        • Recruiting
        • Texas Retina Associates
      • Dallas, Texas, United States, 75390
        • Recruiting
        • UT, Southwestern Medical Center
      • San Antonio, Texas, United States, 78240
        • Recruiting
        • Retina Associates of South Texas, P.A.
      • Southlake, Texas, United States, 76092
        • Recruiting
        • Retina Center Of Texas
      • The Woodlands, Texas, United States, 77401
        • Recruiting
        • Retina Consultants of Texas
    • Utah
      • Salt Lake City, Utah, United States, 84107
        • Recruiting
        • Retina Associates of Utah
    • Washington
      • Bellevue, Washington, United States, 98004
        • Recruiting
        • Vitreoretinal Associates of Washington
      • Burlington, Washington, United States, 98233
        • Recruiting
        • Pacific NW Retina
      • Seattle, Washington, United States, 98104
        • Recruiting
        • University of Washington Medical Center
    • Wisconsin
      • Madison, Wisconsin, United States, 53705
        • Recruiting
        • University of Wisconsin Madison

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: High dose bel-sar treatment arm & laser application
High dose of bel-sar + laser application
Device: Suprachoroidal Microinjector
Suprachoroidal injection device
Other Names:
  • SCS Microinjector
Device: Infrared Laser
Laser application
Drug: Bel-sar
Bel-sar via suprachoroidal administration followed by laser application.
Other Names:
  • AU-011
Experimental: Low dose bel-sar treatment arm & laser application
Low dose of bel-sar + laser application
Device: Suprachoroidal Microinjector
Suprachoroidal injection device
Other Names:
  • SCS Microinjector
Device: Infrared Laser
Laser application
Drug: Bel-sar
Bel-sar via suprachoroidal administration followed by laser application.
Other Names:
  • AU-011
Sham Comparator: Sham control arm & sham laser
Sham injection + sham laser
Device: Sham Infrared Laser
Sham laser application
Device: Sham Microinjector
Sham injection device

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Time to reach tumor progression
Time Frame: 65 weeks
Tumor Progression
65 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Time to composite endpoint
Time Frame: 65 weeks
Tumor progression or visual acuity failure
65 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Aura Biosciences

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Medical Monitor, Aura Biosciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 6, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 15, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 15, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 17, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 17, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 23, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 2, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 26, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • AU-011-301

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Ocular Melanoma

Clinical Trials on Suprachoroidal Microinjector

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings