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Trial Title:
Suprachoroidal Administration in Subjects With Choroidal Metastasis From Breast or Lung Primary Tumors
NCT ID:
NCT06643884
Condition:
Eye Cancer
Metastatic Breast Cancer
Lung Cancer
Conditions: Official terms:
Neoplasm Metastasis
Eye Neoplasms
Conditions: Keywords:
Choriodal Metastatis
Metastasis to the Choroid
ocular
eye
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
AU-011
Description:
AU-011 Via Suprachoroidal Administration with laser treatment
Arm group label:
160 micrograms of bel-sar
Arm group label:
200 micrograms of bel-sar with one cycle
Arm group label:
200 micrograms of bel-sar with two cycles
Arm group label:
80 micrograms of bel-sar
Intervention type:
Device
Intervention name:
SCS Microinjector
Description:
Suprachoroidal Injection Device
Arm group label:
160 micrograms of bel-sar
Arm group label:
200 micrograms of bel-sar with one cycle
Arm group label:
200 micrograms of bel-sar with two cycles
Arm group label:
80 micrograms of bel-sar
Intervention type:
Device
Intervention name:
Laser
Description:
Laser Administration
Arm group label:
160 micrograms of bel-sar
Arm group label:
200 micrograms of bel-sar with one cycle
Arm group label:
200 micrograms of bel-sar with two cycles
Arm group label:
80 micrograms of bel-sar
Summary:
The primary objective is to assess the safety and tolerability of bel-sar treatment in
subjects with choroidal metastasis from breast or lung primary tumors.
Detailed description:
This is an open-label, dose escalation trial designed to assess safety and tolerability
of 4 dose strengths and 1-2 cycles of bel-sar treatment in subjects with choroidal
metastasis from breast or lung primary tumors.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Have a clinical diagnosis of Choroidal Metastasis, from a histopathologically or
cytologically confirmed breast or lung primary tumor.
- Have a single Choroidal Metastasis in only 1 eye, and no Choroidal Metastasis in the
other eye (i.e., unilateral, unifocal Choroidal Metastasis).
Exclusion Criteria:
- Active ocular infection or disease.
- Must not have evidence of a primary tumor or metastatic lesion in the brain
requiring treatment with radiation therapy per the primary treating oncologist's
assessment.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Byers Eye Institute at Stanford University
Address:
City:
Palo Alto
Zip:
94303
Country:
United States
Facility:
Name:
Bascom Palmer Eye Institute
Address:
City:
Miami
Zip:
33136
Country:
United States
Facility:
Name:
Massachusetts Eye and Ear
Address:
City:
Boston
Zip:
02114
Country:
United States
Facility:
Name:
Kellogg Eye Center
Address:
City:
Ann Arbor
Zip:
48105
Country:
United States
Facility:
Name:
Cleveland Clinic, Cole Eye Institute
Address:
City:
Cleveland
Zip:
44195
Country:
United States
Facility:
Name:
Sheilds and Sheilds, PC
Address:
City:
Philadelphia
Zip:
19107
Country:
United States
Facility:
Name:
Tennessee Retina, PC
Address:
City:
Nashville
Zip:
37203
Country:
United States
Facility:
Name:
Retina Consultants of Texas
Address:
City:
Bellaire
Zip:
77401
Country:
United States
Facility:
Name:
University of Washington
Address:
City:
Seattle
Zip:
98104
Country:
United States
Start date:
October 25, 2024
Completion date:
December 30, 2026
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/NCT06643884
