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

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Aura Biosciences
Study ID
NCT06007690
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

  • Choroidal Melanoma
  • Indeterminate Lesions
  • Ocular Melanoma
  • Uveal Melanoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Bel-sar — DRUG
    Bel-sar via suprachoroidal administration followed by laser application.
  • Suprachoroidal Microinjector — DEVICE
    Suprachoroidal injection device
  • Infrared Laser — DEVICE
    Laser application
  • Sham Infrared Laser — DEVICE
    Sham laser application
  • Sham Microinjector — DEVICE
    Sham injection device

Study Details

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).

Key Dates

Start date
Dec 6, 2023
Status verified
Feb 2026
Primary completion
Nov 15, 2027
Completion
Aug 15, 2028

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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 injection + sham laser

Primary Outcome Measure

Time to reach tumor progression [ Time Frame: 65 weeks ]

Central Contacts

Locations (36)

FacilityCityStateZIPSite coordinators
Retina Consultants of AlabamaBirminghamAlabama35233-
UCSD Shiley Eye Institute, Jacobs Retina CenterLa JollaCalifornia92093-
Doris Stein Eye Research CenterLos AngelesCalifornia90095-
Stanford University School of MedicinePalo AltoCalifornia94303-
Retinal Consultants Medical Group, Inc.SacramentoCalifornia95825-
Bascom Palmer Eye InstituteMiamiFlorida33136-
Retina Associates of Florida, PATampaFlorida33609-
Emory Eye CenterAtlantaGeorgia30322-
University of Illinois at ChicagoChicagoIllinois60612-
Massachusetts Eye and EarBostonMassachusetts02114-
Tufts Medical Center New England Eye CenterBostonMassachusetts02111-
W.K. Kellogg Eye Center - University of MichiganAnn ArborMichigan48105-
Associated Retinal Consultants (ARC) P.C.Royal OakMichigan48073-
Mayo ClinicRochesterMinnesota55905-
Washington UniversitySt LouisMissouri63110-
Nebraska Medicine's Truhlsen Eye InstituteOmahaNebraska68105-
Columbia University Irving Medical CenterNew YorkNew York10032-
Duke Eye CenterDurhamNorth Carolina27705-
Cole Eye InstituteClevelandOhio44195-
Dean McGee Eye InstituteOklahoma CityOklahoma73104-
Retina Consultants of OklahomaOklahoma CityOklahoma73112-
Shields & Shields PC-Wills Eye InstitutePhiladelphiaPennsylvania19107-
Retina Consultants of CarolinaGreenvilleSouth Carolina29605-
Southeastern Retina AssociatesChattanoogaTennessee37421-
Tennessee Retina, PCNashvilleTennessee37203-
Austin Retina AssociatesAustinTexas78705-
Texas Retina AssociatesDallasTexas75231-
UT, Southwestern Medical CenterDallasTexas75390-
Retina Associates of South Texas, P.A.San AntonioTexas78240-
Retina Center of TexasSouthlakeTexas76092-
Retina Consultants of TexasThe WoodlandsTexas77401-
Retina Associates of UtahSalt Lake CityUtah84107-
Vitreoretinal Associates of WashingtonBellevueWashington98004-
Pacific NW RetinaBurlingtonWashington98233-
University of Washington Medical CenterSeattleWashington98104-
University of Wisconsin MadisonMadisonWisconsin53705-

Find similar trials in Birmingham, AL

By research site
Retina Consultants of Alabama· Birmingham, ALUCSD Shiley Eye Institute, Jacobs Retina Center· La Jolla, CADoris Stein Eye Research Center· Los Angeles, CAStanford University School of Medicine· Palo Alto, CARetinal Consultants Medical Group, Inc.· Sacramento, CABascom Palmer Eye Institute· Miami, FL

Related Studies