Melanoma Clinical Trial

Phase 2 Trial to Evaluate Belzupacap Sarotalocan (AU-011) Via Suprachoroidal Administration in Subjects With Primary Indeterminate Lesions and Small Choroidal Melanoma

Summary

The primary objective is to assess safety and efficacy of AU-011 via suprachoroidal injection to treat primary indeterminate lesions and small choroidal melanoma.

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Full Description

A Phase 2 Trial of AU-011 Via Suprachoroidal Administration With a Dose Escalation Phase (Open-label, Ascending Single and Repeat Dose) and a Randomized, Masked Confirmatory Phase Designed to Evaluate the Safety and Efficacy of AU-011 in Subjects With Primary Indeterminate Lesions and Small Choroidal Melanoma.

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 naïve for IL/CM

Exclusion Criteria:

Have known contraindications or sensitivities to the study drug or laser
Active ocular disease

Study is for people with:

Melanoma

Phase:

Phase 2

Estimated Enrollment:

22

Study ID:

NCT04417530

Recruitment Status:

Recruiting

Sponsor:

Aura Biosciences

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There are 22 Locations for this study

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Retina Associates SW, P.C.
Tucson Arizona, 85710, United States
UCLA Jules Stein Eye Institute
Los Angeles California, 90095, United States
Byers Eye Institute at Stanford University
Palo Alto California, 94303, United States More Info
Mariana Nunez
Contact
UCHealth Eye Center
Aurora Colorado, 80045, United States More Info
Mary Preston
Contact
Retina Associates of Florida
Tampa Florida, 33609, United States More Info
Samantha Spritz
Contact
Emory Eye Center
Atlanta Georgia, 30322, United States
University of Illinois At Chicago Illinois Eye and Ear Infirmary
Chicago Illinois, 60612, United States More Info
Bhavana Kolli
Contact
Midwest Eye Institute
Carmel Indiana, 46290, United States More Info
Erin Brown
Contact
University of Iowa Department of Ophthalmology and Visual Sciences
Iowa City Iowa, 52242, United States
Massachusetts Eye and Ear Infirmary
Boston Massachusetts, 02114, United States More Info
Grayson Hanlon
Contact
W. K. Kellogg Eye Center, University of Michigan
Ann Arbor Michigan, 48105, United States More Info
Pamela Campbell
Contact
Associated Retinal Consultants, PC
Royal Oak Michigan, 48073, United States More Info
Kendra Mellert
Contact
Retina Center
Minneapolis Minnesota, 55404, United States
Columbia University Medical Center
New York New York, 10027, United States More Info
Ellen Alt
Contact
Dean McGee Eye Institute
Oklahoma City Oklahoma, 73104, United States More Info
Ashley Ellis
Contact
Oregon Health & Science University Casey Eye Institute
Portland Oregon, 97239, United States More Info
Ann Lundquist
Contact
Wills Eye Hospital
Philadelphia Pennsylvania, 19107, United States
Retina Consultants of Carolina, PA
Greenville South Carolina, 29605, United States More Info
Lauren Frazier
Contact
St. Thomas Health / Tennessee Retina, PC
Nashville Tennessee, 37203, United States More Info
Lisa Walden
Contact
Texas Retina Associates
Dallas Texas, 75231, United States More Info
Sally Arceneaux
Contact
Retina Consultants of Houston
Houston Texas, 77030, United States More Info
Allison Stroh
Contact
University of Wisconsin Dept of Ophthalmology & Visual Sciences
Madison Wisconsin, 53705, United States More Info
Bonnie Verges
Contact

How clear is this clinincal trial information?

Study is for people with:

Melanoma

Phase:

Phase 2

Estimated Enrollment:

22

Study ID:

NCT04417530

Recruitment Status:

Recruiting

Sponsor:


Aura Biosciences

How clear is this clinincal trial information?

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