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

PHASE3RecruitingINTERVENTIONAL
Enrollment

100

Participants

Timeline

Start Date

December 6, 2023

Primary Completion Date

March 1, 2026

Study Completion Date

March 1, 2027

Conditions
Choroidal MelanomaIndeterminate LesionsUveal MelanomaOcular Melanoma
Interventions
DRUG

Bel-sar

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

Trial Locations (63)

1050

RECRUITING

Auckland Eye Ltd, Auckland

1090

RECRUITING

Medizinische Universität Wien, Department of Ophthalmology and Optometry, Vienna

3000

RECRUITING

UZ Leuven, Leuven

3002

RECRUITING

Eye Research Australia, East Melbourne

4000

RECRUITING

Terrace Eye Centre, Brisbane

10032

NOT_YET_RECRUITING

Columbia University Irving Medical Center, New York

12203

RECRUITING

Charité - Universitätsmedizin Berlin KöR, Berlin

14059

RECRUITING

Fakultni Thomayerova nemocnice, Prague

15706

RECRUITING

Hospital Provincial de Conxo, Santiago de Compostela

16902

RECRUITING

Ustredni vojenska nemocnice Vojenska fakultni nemocnice Praha, Prague

19107

RECRUITING

Shields & Shields PC-Wills Eye Institute, Philadelphia

20157

RECRUITING

Ospedale Fatebenefratelli e Oftalmico, ASST Fatebenefratelli Sacco, Milan

23538

RECRUITING

Universitätsklinikum Schleswig-Holstein Klinik für Augenheilkunde, Lübeck

27705

RECRUITING

Duke Eye Center, Durham

29605

RECRUITING

Retina Consultants of Carolina, Greenville

30322

RECRUITING

Emory Eye Center, Atlanta

32300

RECRUITING

Fakultni nemocnice Plzen, Pilsen

33136

RECRUITING

Bascom Palmer Eye Institute, Miami

33609

RECRUITING

Retina Associates of Florida, PA, Tampa

35233

RECRUITING

Retina Consultants of Alabama, Birmingham

37203

RECRUITING

Tennessee Retina, PC, Nashville

37421

RECRUITING

Southeastern Retina Associates, Chattanooga

44195

RECRUITING

Cole Eye Institute, Cleveland

48073

RECRUITING

Associated Retinal Consultants (ARC) P.C., Royal Oak

48105

RECRUITING

W.K. Kellogg Eye Center - University of Michigan, Ann Arbor

50134

RECRUITING

AOUC Azienda Ospedaliero-Universitaria Careggi, Florence

53705

RECRUITING

University of Wisconsin Madison, Madison

55905

RECRUITING

Mayo Clinic, Rochester

60612

RECRUITING

University of Illinois at Chicago, Chicago

63110

NOT_YET_RECRUITING

Washington University, St Louis

68105

RECRUITING

Nebraska Medicine's Truhlsen Eye Institute, Omaha

72076

RECRUITING

Universitätsklinikum Tübingen, Tübingen

73104

RECRUITING

Dean McGee Eye Institute, Oklahoma City

75231

RECRUITING

Texas Retina Associates, Dallas

75390

RECRUITING

UT, Southwestern Medical Center, Dallas

76092

RECRUITING

Retina Center of Texas, Southlake

77401

RECRUITING

Retina Consultants of Texas, The Woodlands

78240

RECRUITING

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

78705

RECRUITING

Austin Retina Associates, Austin

80336

RECRUITING

Klinikum der LMU Muenchen, München

84107

RECRUITING

Retina Associates of Utah, Salt Lake City

90095

NOT_YET_RECRUITING

Doris Stein Eye Research Center, Los Angeles

92093

RECRUITING

UCSD Shiley Eye Institute, Jacobs Retina Center, La Jolla

94303

RECRUITING

Stanford University School of Medicine, Palo Alto

95825

RECRUITING

Retinal Consultants Medical Group, Inc., Sacramento

98004

RECRUITING

Vitreoretinal Associates of Washington, Bellevue

98104

RECRUITING

University of Washington Medical Center, Seattle

5262100

RECRUITING

The Chaim Sheba Medical Center, Tel-Hashomer

9112001

RECRUITING

Hadassah Medical Center, Ein-Karem, Jerusalem

02111

RECRUITING

Tufts Medical Center New England Eye Center, Boston

02114

RECRUITING

Massachusetts Eye and Ear, Boston

07470

NOT_YET_RECRUITING

New Jersey Retina Group, Wayne

T2V 4Y8

NOT_YET_RECRUITING

Serac Eye and Skin Care Centre, Calgary

M5G 2M9

NOT_YET_RECRUITING

Princess Margaret Eye Tumour Clinic, Toronto

G1S 4L8

RECRUITING

Centre Hospitalier de l'Universite Laval, Québec

06001

RECRUITING

Centre Hospitalier Universitaire de Nice, Nice

00168

RECRUITING

Universita'Cattolica Del Sacro Cuore - UNICATT, Roma

2333 ZE

RECRUITING

Leids Universitair Medisch Centrum (LUMC), Leiden

3015AA

RECRUITING

Erasmus MC, Rotterdam

08907

RECRUITING

Hospital Universitario de Bellvitge, Barcelona

L7 8XP

NOT_YET_RECRUITING

Royal Liverpool University Hospital Nhs Foundation Trust Broadgreen Hospital, Liverpool

EC1V 2PD

RECRUITING

Moorfields Eye Hospital NHS Foundation Trust, London

S10 2JF

RECRUITING

Nhs Foundation Trust - Royal Hallamshire Hospital, Sheffield

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Aura Biosciences

INDUSTRY

NCT06007690 - 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 | Biotech Hunter | Biotech Hunter