Melanoma Clinical Trial

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

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).

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Full 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.

View Eligibility Criteria

Eligibility 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

Study is for people with:

Melanoma

Phase:

Phase 3

Estimated Enrollment:

100

Study ID:

NCT06007690

Recruitment Status:

Recruiting

Sponsor:

Aura Biosciences

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There are 32 Locations for this study

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Retina Consultants of Alabama
Birmingham Alabama, 35233, United States
UCSD Shiley Eye Institute, Jacobs Retina Center
La Jolla California, 92093, United States
Stanford University School of Medicine
Palo Alto California, 94303, United States
Retinal Consultants Medical Group, Inc.
Sacramento California, 95825, United States
Colorado Retina Associates
Lakewood Colorado, 80228, United States
Retina Associates of Florida, PA
Tampa Florida, 33609, United States
Emory Eye Center
Atlanta Georgia, 30322, United States
University of Illinois at Chicago
Chicago Illinois, 60612, United States
Massachusetts Eye and Ear
Boston Massachusetts, 02114, United States
Ophthalmic Consultants of Boston
Boston Massachusetts, 02116, United States
W.K. Kellogg Eye Center - University of Michigan
Ann Arbor Michigan, 48105, United States
Associated Retinal Consultants (ARC) P.C.
Royal Oak Michigan, 48073, United States
Mayo Clinic
Rochester Minnesota, 55905, United States
Nebraska Medicine's Truhlsen Eye Institute
Omaha Nebraska, 68105, United States
University of Rochester, Flaum Eye Institute
Rochester New York, 14642, United States
Duke Eye Center
Durham North Carolina, 27705, United States
Cole Eye Institute
Cleveland Ohio, 44195, United States
Dean McGee Eye Institute
Oklahoma City Oklahoma, 73104, United States
Thomas Jefferson University (TJU) - Wills Eye Institute
Philadelphia Pennsylvania, 19107, United States
Retina Consultants of Carolina
Greenville South Carolina, 29605, United States
University of Tennessee Hamilton Eye Institute
Memphis Tennessee, 38103, United States
Tennessee Retina, PC
Nashville Tennessee, 37203, United States
Austin Retina Associates
Austin Texas, 78705, United States
Texas Retina Associates
Dallas Texas, 75231, United States
UT, Southwestern Medical Center
Dallas Texas, 75390, United States
Retina Associates of South Texas, P.A.
San Antonio Texas, 78240, United States
Retina Center of Texas
Southlake Texas, 76092, United States
Retina Consultants of Texas
The Woodlands Texas, 77401, United States
Retina Associates of Utah
Salt Lake City Utah, 84107, United States
Vitreoretinal Associates of Washington
Bellevue Washington, 98004, United States
University of Washington Medical Center
Seattle Washington, 98104, United States
University of Wisconsin Madison
Madison Wisconsin, 53705, United States

How clear is this clinincal trial information?

Study is for people with:

Melanoma

Phase:

Phase 3

Estimated Enrollment:

100

Study ID:

NCT06007690

Recruitment Status:

Recruiting

Sponsor:


Aura Biosciences

How clear is this clinincal trial information?

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