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).
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.
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
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There are 38 Locations for this study
Birmingham Alabama, 35233, United States
La Jolla California, 92093, United States
Palo Alto California, 94303, United States
Sacramento California, 95825, United States
Lakewood Colorado, 80228, United States
Tampa Florida, 33609, United States
Atlanta Georgia, 30322, United States
Chicago Illinois, 60612, United States
Boston Massachusetts, 02114, United States
Boston Massachusetts, 02116, United States
Ann Arbor Michigan, 48105, United States
Royal Oak Michigan, 48073, United States
Rochester Minnesota, 55905, United States
Omaha Nebraska, 68105, United States
Rochester New York, 14642, United States
Durham North Carolina, 27705, United States
Cleveland Ohio, 44195, United States
Columbus Ohio, 43212, United States
Oklahoma City Oklahoma, 73104, United States
Philadelphia Pennsylvania, 19107, United States
Greenville South Carolina, 29605, United States
Memphis Tennessee, 38103, United States
Nashville Tennessee, 37203, United States
Austin Texas, 78705, United States
Dallas Texas, 75231, United States
Dallas Texas, 75390, United States
San Antonio Texas, 78240, United States
Southlake Texas, 76092, United States
The Woodlands Texas, 77401, United States
Salt Lake City Utah, 84107, United States
Bellevue Washington, 98004, United States
Seattle Washington, 98104, United States
Madison Wisconsin, 53705, United States
Brisbane Queensland, 4000, Australia
East Melbourne Victoria, 3002, Australia
Liverpool England, L7 8X, United Kingdom
London England, EC1V , United Kingdom
Sheffield South Yorkshire, S10 2, United Kingdom
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