Trial 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
NCT ID:
NCT06007690
Condition:
Choroidal Melanoma
Indeterminate Lesions
Uveal Melanoma
Ocular Melanoma
Conditions: Official terms:
Melanoma
Conditions: Keywords:
Uveal Melanoma
Eye Cancer
Ocular Melanoma
Choroidal Melanoma
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Double (Participant, Outcomes Assessor)
Masking description:
Subject, Assessor, and Sponsor masked trial.
Intervention:
Intervention type:
Drug
Intervention name:
Bel-sar
Description:
Bel-sar via suprachoroidal administration followed by laser application.
Arm group label:
High dose bel-sar treatment arm & laser application
Arm group label:
Low dose bel-sar treatment arm & laser application
Other name:
AU-011
Intervention type:
Device
Intervention name:
Suprachoroidal Microinjector
Description:
Suprachoroidal injection device
Arm group label:
High dose bel-sar treatment arm & laser application
Arm group label:
Low dose bel-sar treatment arm & laser application
Other name:
SCS Microinjector
Intervention type:
Device
Intervention name:
Infrared Laser
Description:
Laser application
Arm group label:
High dose bel-sar treatment arm & laser application
Arm group label:
Low dose bel-sar treatment arm & laser application
Intervention type:
Device
Intervention name:
Sham Infrared Laser
Description:
Sham laser application
Arm group label:
Sham control arm & sham laser
Intervention type:
Device
Intervention name:
Sham Microinjector
Description:
Sham injection device
Arm group label:
Sham control arm & sham laser
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).
Detailed 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.
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Retina Consultants of Alabama
Address:
City:
Birmingham
Zip:
35233
Country:
United States
Status:
Recruiting
Facility:
Name:
UCSD Shiley Eye Institute, Jacobs Retina Center
Address:
City:
La Jolla
Zip:
92093
Country:
United States
Status:
Recruiting
Facility:
Name:
Doris Stein Eye Research Center
Address:
City:
Los Angeles
Zip:
90095
Country:
United States
Status:
Not yet recruiting
Facility:
Name:
Stanford University School of Medicine
Address:
City:
Palo Alto
Zip:
94303
Country:
United States
Status:
Recruiting
Facility:
Name:
Retinal Consultants Medical Group, Inc.
Address:
City:
Sacramento
Zip:
95825
Country:
United States
Status:
Recruiting
Facility:
Name:
UCSF Ocular Oncology Clinic
Address:
City:
San Francisco
Zip:
94143
Country:
United States
Status:
Not yet recruiting
Facility:
Name:
Colorado Retina Associates
Address:
City:
Lakewood
Zip:
80228
Country:
United States
Status:
Recruiting
Facility:
Name:
Bascom Palmer Eye Institute
Address:
City:
Miami
Zip:
33136
Country:
United States
Status:
Recruiting
Facility:
Name:
Retina Associates of Florida, PA
Address:
City:
Tampa
Zip:
33609
Country:
United States
Status:
Recruiting
Facility:
Name:
Emory Eye Center
Address:
City:
Atlanta
Zip:
30322
Country:
United States
Status:
Recruiting
Facility:
Name:
University of Illinois at Chicago
Address:
City:
Chicago
Zip:
60612
Country:
United States
Status:
Recruiting
Facility:
Name:
Tufts Medical Center New England Eye Center
Address:
City:
Boston
Zip:
02111
Country:
United States
Status:
Recruiting
Facility:
Name:
Massachusetts Eye and Ear
Address:
City:
Boston
Zip:
02114
Country:
United States
Status:
Recruiting
Facility:
Name:
W.K. Kellogg Eye Center - University of Michigan
Address:
City:
Ann Arbor
Zip:
48105
Country:
United States
Status:
Recruiting
Facility:
Name:
Associated Retinal Consultants (ARC) P.C.
Address:
City:
Royal Oak
Zip:
48073
Country:
United States
Status:
Recruiting
Facility:
Name:
Mayo Clinic
Address:
City:
Rochester
Zip:
55905
Country:
United States
Status:
Recruiting
Facility:
Name:
Washington University
Address:
City:
Saint Louis
Zip:
63110
Country:
United States
Status:
Not yet recruiting
Facility:
Name:
Nebraska Medicine's Truhlsen Eye Institute
Address:
City:
Omaha
Zip:
68105
Country:
United States
Status:
Recruiting
Facility:
Name:
New Jersey Retina Group
Address:
City:
Wayne
Zip:
07470
Country:
United States
Status:
Not yet recruiting
Facility:
Name:
Columbia University Irving Medical Center
Address:
City:
New York
Zip:
10032
Country:
United States
Status:
Not yet recruiting
Facility:
Name:
University of Rochester, Flaum Eye Institute
Address:
City:
Rochester
Zip:
14642
Country:
United States
Status:
Not yet recruiting
Facility:
Name:
Duke Eye Center
Address:
City:
Durham
Zip:
27705
Country:
United States
Status:
Not yet recruiting
Facility:
Name:
Cole Eye Institute
Address:
City:
Cleveland
Zip:
44195
Country:
United States
Status:
Recruiting
Facility:
Name:
Dean McGee Eye Institute
Address:
City:
Oklahoma City
Zip:
73104
Country:
United States
Status:
Recruiting
Facility:
Name:
Shields & Shields PC-Wills Eye Institute
Address:
City:
Philadelphia
Zip:
19107
Country:
United States
Status:
Recruiting
Facility:
Name:
Retina Consultants of Carolina
Address:
City:
Greenville
Zip:
29605
Country:
United States
Status:
Recruiting
Facility:
Name:
Southeastern Retina Associates
Address:
City:
Chattanooga
Zip:
37421
Country:
United States
Status:
Not yet recruiting
Facility:
Name:
Tennessee Retina, PC
Address:
City:
Nashville
Zip:
37203
Country:
United States
Status:
Recruiting
Facility:
Name:
Austin Retina Associates
Address:
City:
Austin
Zip:
78705
Country:
United States
Status:
Recruiting
Facility:
Name:
Texas Retina Associates
Address:
City:
Dallas
Zip:
75231
Country:
United States
Status:
Recruiting
Facility:
Name:
UT, Southwestern Medical Center
Address:
City:
Dallas
Zip:
75390
Country:
United States
Status:
Recruiting
Facility:
Name:
Retina Associates of South Texas, P.A.
Address:
City:
San Antonio
Zip:
78240
Country:
United States
Status:
Recruiting
Facility:
Name:
Retina Center of Texas
Address:
City:
Southlake
Zip:
76092
Country:
United States
Status:
Recruiting
Facility:
Name:
Retina Consultants of Texas
Address:
City:
The Woodlands
Zip:
77401
Country:
United States
Status:
Recruiting
Facility:
Name:
Retina Associates of Utah
Address:
City:
Salt Lake City
Zip:
84107
Country:
United States
Status:
Recruiting
Facility:
Name:
Moran Eye Center University of Utah
Address:
City:
Salt Lake City
Zip:
84132
Country:
United States
Status:
Not yet recruiting
Facility:
Name:
Vitreoretinal Associates of Washington
Address:
City:
Bellevue
Zip:
98004
Country:
United States
Status:
Recruiting
Facility:
Name:
University of Washington Medical Center
Address:
City:
Seattle
Zip:
98104
Country:
United States
Status:
Recruiting
Facility:
Name:
University of Wisconsin Madison
Address:
City:
Madison
Zip:
53705
Country:
United States
Status:
Recruiting
Facility:
Name:
Terrace Eye Centre
Address:
City:
Brisbane
Zip:
4000
Country:
Australia
Status:
Not yet recruiting
Facility:
Name:
Eye Research Australia
Address:
City:
East Melbourne
Zip:
3002
Country:
Australia
Status:
Recruiting
Facility:
Name:
Alberta Health Services (AHS) Tom Baker Cancer Center
Address:
City:
Calgary
Zip:
T2N4N2
Country:
Canada
Status:
Not yet recruiting
Facility:
Name:
Princess Margaret Eye Tumour Clinic
Address:
City:
Toronto
Zip:
M5G 2M9
Country:
Canada
Status:
Not yet recruiting
Facility:
Name:
Centre Hospitalier de l'Universite Laval
Address:
City:
Québec City
Zip:
G1S 4L8
Country:
Canada
Status:
Not yet recruiting
Facility:
Name:
The Chaim Sheba Medical Center
Address:
City:
Tel-Hashomer
Zip:
5262100
Country:
Israel
Status:
Not yet recruiting
Facility:
Name:
Hadassah Medical Center, Ein-Karem
Address:
City:
Jerusalem
Zip:
9112001
Country:
Israel
Status:
Not yet recruiting
Facility:
Name:
Royal Liverpool University Hospital Nhs Foundation Trust Broadgreen Hospital
Address:
City:
Liverpool
Zip:
L7 8XP
Country:
United Kingdom
Status:
Not yet recruiting
Facility:
Name:
Moorfields Eye Hospital NHS Foundation Trust
Address:
City:
London
Zip:
EC1V 2PD
Country:
United Kingdom
Status:
Recruiting
Facility:
Name:
Nhs Foundation Trust - Royal Hallamshire Hospital
Address:
City:
Sheffield
Zip:
S10 2JF
Country:
United Kingdom
Status:
Not yet recruiting
Start date:
December 6, 2023
Completion date:
March 1, 2027
Lead sponsor:
Agency:
Aura Biosciences
Agency class:
Industry
Source:
Aura Biosciences
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06007690
http://www.aurabiosciences.com
