Actively Recruiting
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
Led by Aura Biosciences · Updated on 2026-03-02
100
Participants Needed
71
Research Sites
244 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Clinical diagnosis of primary indeterminate lesion or small choroidal melanoma (IL/CM)
- No evidence of metastatic disease confirmed by imaging
- Treatment naive for IL/CM (subjects who received photodynamic therapy may be eligible)
You will not qualify if you...
- Known contraindications or sensitivities to the study drug or laser
- Active ocular infection or disease
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 71 locations
1
Retina Consultants of Alabama
Birmingham, Alabama, United States, 35233
Withdrawn
2
UCSD Shiley Eye Institute, Jacobs Retina Center
La Jolla, California, United States, 92093
Actively Recruiting
3
Doris Stein Eye Research Center
Los Angeles, California, United States, 90095
Actively Recruiting
4
Stanford University School of Medicine
Palo Alto, California, United States, 94303
Actively Recruiting
5
Retinal Consultants Medical Group, Inc.
Sacramento, California, United States, 95825
Actively Recruiting
6
Bascom Palmer Eye Institute
Miami, Florida, United States, 33136
Withdrawn
7
Retina Associates of Florida, PA
Tampa, Florida, United States, 33609
Actively Recruiting
8
Emory Eye Center
Atlanta, Georgia, United States, 30322
Actively Recruiting
9
University of Illinois at Chicago
Chicago, Illinois, United States, 60612
Actively Recruiting
10
Tufts Medical Center New England Eye Center
Boston, Massachusetts, United States, 02111
Actively Recruiting
11
Massachusetts Eye and Ear
Boston, Massachusetts, United States, 02114
Actively Recruiting
12
W.K. Kellogg Eye Center - University of Michigan
Ann Arbor, Michigan, United States, 48105
Actively Recruiting
13
Associated Retinal Consultants (ARC) P.C.
Royal Oak, Michigan, United States, 48073
Actively Recruiting
14
Mayo Clinic
Rochester, Minnesota, United States, 55905
Actively Recruiting
15
Washington University
St Louis, Missouri, United States, 63110
Actively Recruiting
16
Nebraska Medicine's Truhlsen Eye Institute
Omaha, Nebraska, United States, 68105
Actively Recruiting
17
Columbia University Irving Medical Center
New York, New York, United States, 10032
Actively Recruiting
18
Duke Eye Center
Durham, North Carolina, United States, 27705
Actively Recruiting
19
Cole Eye Institute
Cleveland, Ohio, United States, 44195
Actively Recruiting
20
Dean McGee Eye Institute
Oklahoma City, Oklahoma, United States, 73104
Actively Recruiting
21
Retina Consultants of Oklahoma
Oklahoma City, Oklahoma, United States, 73112
Actively Recruiting
22
Shields & Shields PC-Wills Eye Institute
Philadelphia, Pennsylvania, United States, 19107
Actively Recruiting
23
Retina Consultants of Carolina
Greenville, South Carolina, United States, 29605
Actively Recruiting
24
Southeastern Retina Associates
Chattanooga, Tennessee, United States, 37421
Actively Recruiting
25
Tennessee Retina, PC
Nashville, Tennessee, United States, 37203
Actively Recruiting
26
Austin Retina Associates
Austin, Texas, United States, 78705
Actively Recruiting
27
Texas Retina Associates
Dallas, Texas, United States, 75231
Actively Recruiting
28
UT, Southwestern Medical Center
Dallas, Texas, United States, 75390
Actively Recruiting
29
Retina Associates of South Texas, P.A.
San Antonio, Texas, United States, 78240
Actively Recruiting
30
Retina Center of Texas
Southlake, Texas, United States, 76092
Actively Recruiting
31
Retina Consultants of Texas
The Woodlands, Texas, United States, 77401
Actively Recruiting
32
Retina Associates of Utah
Salt Lake City, Utah, United States, 84107
Actively Recruiting
33
Vitreoretinal Associates of Washington
Bellevue, Washington, United States, 98004
Actively Recruiting
34
Pacific NW Retina
Burlington, Washington, United States, 98233
Actively Recruiting
35
University of Washington Medical Center
Seattle, Washington, United States, 98104
Actively Recruiting
36
University of Wisconsin Madison
Madison, Wisconsin, United States, 53705
Actively Recruiting
37
Terrace Eye Centre
Brisbane, Queensland, Australia, 4000
Actively Recruiting
38
Eye Research Australia
East Melbourne, Victoria, Australia, 3002
Actively Recruiting
39
Medical University Graz
Graz, Austria, 8036
Actively Recruiting
40
Medizinische Universität Wien, Department of Ophthalmology and Optometry
Vienna, Austria, 1090
Actively Recruiting
41
Cliniques universitaires Saint-Luc
Brussels, Belgium
Actively Recruiting
42
UZ Leuven
Leuven, Belgium, 3000
Actively Recruiting
43
Serac Eye and Skin Care Centre
Calgary, Alberta, Canada, T2V 4Y8
Actively Recruiting
44
Centre Hospitalier de l'Universite Laval
Québec, Quebec, Canada, G1S 4L8
Actively Recruiting
45
Fakultni Thomayerova nemocnice
Prague, Krč, Czechia, 14059
Actively Recruiting
46
Fakultni nemocnice Plzen
Pilsen, Plzenský Kraj, Czechia, 32300
Actively Recruiting
47
Ustredni vojenska nemocnice Vojenska fakultni nemocnice Praha
Prague, Czechia, 16902
Actively Recruiting
48
Centre Hospitalier Universitaire de Nice
Nice, Cedex 1, France, 06001
Actively Recruiting
49
Hospices Civils de Lyon - Hôpital de La Croix Rousse - Hospital
Lyon, Rhone, France, 69004
Actively Recruiting
50
Charité - Universitätsmedizin Berlin KöR
Berlin, Germany, 12203
Actively Recruiting
51
University Hospital Cologne (AöR)
Cologne, Germany, 50937
Not Yet Recruiting
52
Universitätsmedizin Essen
Essen, Germany, 45147
Actively Recruiting
53
Uniklinikum Hamburg Eppendorf
Hamburg, Germany, 20246
Actively Recruiting
54
Universitätsklinikum Schleswig-Holstein Klinik für Augenheilkunde
Lübeck, Germany, 23538
Actively Recruiting
55
Klinikum der LMU Muenchen
München, Germany, 80336
Actively Recruiting
56
Universitätsklinikum Tübingen
Tübingen, Germany, 72076
Actively Recruiting
57
The Chaim Sheba Medical Center
Tel-Hashomer, Central District, Israel, 5262100
Actively Recruiting
58
Hadassah Medical Center, Ein-Karem
Jerusalem, Jerusalem, Israel, 9112001
Actively Recruiting
59
AOUC Azienda Ospedaliero-Universitaria Careggi
Florence, Italy, 50134
Actively Recruiting
60
Istituto Nazionale dei Tumori, Fondazione IRCCS
Milan, Italy, 20133
Actively Recruiting
61
Ospedale Fatebenefratelli e Oftalmico, ASST Fatebenefratelli Sacco
Milan, Italy, 20157
Actively Recruiting
62
Universita'Cattolica Del Sacro Cuore - UNICATT
Roma, Italy, 00168
Actively Recruiting
63
Leids Universitair Medisch Centrum (LUMC)
Leiden, Netherlands, 2333 ZE
Actively Recruiting
64
Erasmus MC
Rotterdam, Netherlands, 3015AA
Actively Recruiting
65
Auckland Eye Ltd
Auckland, New Zealand, 1050
Actively Recruiting
66
Hospital Universitario de Bellvitge
Barcelona, Spain, 08907
Actively Recruiting
67
Hospital Provincial de Conxo
Santiago de Compostela, Spain, 15706
Actively Recruiting
68
Hospital Virgen Macarena
Seville, Spain, 41009
Actively Recruiting
69
Hospital Universitario Y Politécnico La Fe
Valencia, Spain, 46026
Actively Recruiting
70
Moorfields Eye Hospital NHS Foundation Trust
London, United Kingdom, EC1V 2PD
Actively Recruiting
71
Nhs Foundation Trust - Royal Hallamshire Hospital
Sheffield, United Kingdom, S10 2JF
Actively Recruiting
Research Team
M
Medical Monitor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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