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, 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 dose + sham laser

Interventions

Drug: - Belzupacap Sarotalocan

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

Drug: - Sham Treatment

Sham drug via sham injection followed by sham laser

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, Alabama

Status

Recruiting

Address

Retina Consultants of Alabama

Birmingham, Alabama, 35233

La Jolla, California

Status

Not yet recruiting

Address

UCSD Shiley Eye Institute, Jacobs Retina Center

La Jolla, California, 92093

Stanford University School of Medicine, Palo Alto, California

Status

Recruiting

Address

Stanford University School of Medicine

Palo Alto, California, 94303

Retinal Consultants Medical Group, Inc., Sacramento, California

Status

Recruiting

Address

Retinal Consultants Medical Group, Inc.

Sacramento, California, 95825

Colorado Retina Associates, Lakewood, Colorado

Status

Recruiting

Address

Colorado Retina Associates

Lakewood, Colorado, 80228

Retina Associates of Florida, PA, Tampa, Florida

Status

Recruiting

Address

Retina Associates of Florida, PA

Tampa, Florida, 33609

Emory Eye Center, Atlanta, Georgia

Status

Recruiting

Address

Emory Eye Center

Atlanta, Georgia, 30322

University of Illinois at Chicago, Chicago, Illinois

Status

Recruiting

Address

University of Illinois at Chicago

Chicago, Illinois, 60612

Massachusetts Eye and Ear, Boston, Massachusetts

Status

Recruiting

Address

Massachusetts Eye and Ear

Boston, Massachusetts, 02114

Ophthalmic Consultants of Boston, Boston, Massachusetts

Status

Not yet recruiting

Address

Ophthalmic Consultants of Boston

Boston, Massachusetts, 02116

Ann Arbor, Michigan

Status

Recruiting

Address

W.K. Kellogg Eye Center - University of Michigan

Ann Arbor, Michigan, 48105

Royal Oak, Michigan

Status

Recruiting

Address

Associated Retinal Consultants (ARC) P.C.

Royal Oak, Michigan, 48073

Mayo Clinic, Rochester, Minnesota

Status

Recruiting

Address

Mayo Clinic

Rochester, Minnesota, 55905

Omaha, Nebraska

Status

Recruiting

Address

Nebraska Medicine's Truhlsen Eye Institute

Omaha, Nebraska, 68105

Rochester, New York

Status

Not yet recruiting

Address

University of Rochester, Flaum Eye Institute

Rochester, New York, 14642

Duke Eye Center, Durham, North Carolina

Status

Not yet recruiting

Address

Duke Eye Center

Durham, North Carolina, 27705

Cole Eye Institute, Cleveland, Ohio

Status

Not yet recruiting

Address

Cole Eye Institute

Cleveland, Ohio, 44195

Ohio State Ophthalmic Oncology Service, Columbus, Ohio

Status

Not yet recruiting

Address

Ohio State Ophthalmic Oncology Service

Columbus, Ohio, 43212

Dean McGee Eye Institute, Oklahoma City, Oklahoma

Status

Recruiting

Address

Dean McGee Eye Institute

Oklahoma City, Oklahoma, 73104

Philadelphia, Pennsylvania

Status

Recruiting

Address

Thomas Jefferson University (TJU) - Wills Eye Institute

Philadelphia, Pennsylvania, 19107

Retina Consultants of Carolina, Greenville, South Carolina

Status

Recruiting

Address

Retina Consultants of Carolina

Greenville, South Carolina, 29605

Memphis, Tennessee

Status

Not yet recruiting

Address

University of Tennessee Hamilton Eye Institute

Memphis, Tennessee, 38103

Tennessee Retina, PC, Nashville, Tennessee

Status

Recruiting

Address

Tennessee Retina, PC

Nashville, Tennessee, 37203

Austin Retina Associates, Austin, Texas

Status

Recruiting

Address

Austin Retina Associates

Austin, Texas, 78705

Texas Retina Associates, Dallas, Texas

Status

Recruiting

Address

Texas Retina Associates

Dallas, Texas, 75231

UT, Southwestern Medical Center, Dallas, Texas

Status

Recruiting

Address

UT, Southwestern Medical Center

Dallas, Texas, 75390

Retina Associates of South Texas, P.A., San Antonio, Texas

Status

Recruiting

Address

Retina Associates of South Texas, P.A.

San Antonio, Texas, 78240

Retina Center of Texas, Southlake, Texas

Status

Recruiting

Address

Retina Center of Texas

Southlake, Texas, 76092

Retina Consultants of Texas, The Woodlands, Texas

Status

Recruiting

Address

Retina Consultants of Texas

The Woodlands, Texas, 77401

Retina Associates of Utah, Salt Lake City, Utah

Status

Recruiting

Address

Retina Associates of Utah

Salt Lake City, Utah, 84107

Vitreoretinal Associates of Washington, Bellevue, Washington

Status

Recruiting

Address

Vitreoretinal Associates of Washington

Bellevue, Washington, 98004

University of Washington Medical Center, Seattle, Washington

Status

Recruiting

Address

University of Washington Medical Center

Seattle, Washington, 98104

University of Wisconsin Madison, Madison, Wisconsin

Status

Recruiting

Address

University of Wisconsin Madison

Madison, Wisconsin, 53705

International Sites

Terrace Eye Centre, Brisbane, Queensland, Australia

Status

Not yet recruiting

Address

Terrace Eye Centre

Brisbane, Queensland, 4000

Eye Research Australia, East Melbourne, Victoria, Australia

Status

Not yet recruiting

Address

Eye Research Australia

East Melbourne, Victoria, 3002

Liverpool, England, United Kingdom

Status

Not yet recruiting

Address

Liverpool University Hospitals NHS Foundation Trust Broadgreen Hospital

Liverpool, England, L7 8XP

Moorfields Eye Hospital at City Road, London, England, United Kingdom

Status

Not yet recruiting

Address

Moorfields Eye Hospital at City Road

London, England, EC1V 2PD

Sheffield, South Yorkshire, United Kingdom

Status

Not yet recruiting

Address

Nhs Foundation Trust - Royal Hallamshire Hospital

Sheffield, South Yorkshire, S10 2JF

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