Status:
TERMINATED
Safety and Bioactivity of AXT107 in Subjects With Neovascular Age-Related Macular Degeneration
Lead Sponsor:
AsclepiX Therapeutics, Inc.
Conditions:
Neovascular Age-Related Macular Degeneration (nAMD)
Eligibility:
All Genders
50+ years
Phase:
PHASE1
PHASE2
Brief Summary
This is an open-label, dose-escalating, 48-week study assessing the safety, tolerability, bioactivity and duration of action of a single intravitreal injection of 0.1 mg, 0.25 mg, or 0.5 mg AXT107 in ...
Detailed Description
Upon providing informed consent, subjects will be sequentially enrolled into the study. Decision regarding dose escalation will be based on the recommendation from the Data Monitoring Committee (DMC)....
Eligibility Criteria
Inclusion
- Patients 50 years of age or older diagnosed in the study eye with subfoveal choroidal neovascularization (CNV) or juxtafoveal CNV secondary to AMD
- Best corrected visual acuity (BCVA) Early Treatment Diabetic Retinopathy Study (ETDRS) letter score of 65 to 10 in the study eye
- Willing and able to comply with clinic visits and study-related procedures
- Provide signed inform consent
Exclusion
- Macular edema or CMV secondary to any causes other than AMD in the study eye
- Previously-treated patients who are not responders to anti-VEGF
- Any condition that may preclude improvement in visual acuity in the study eye
- Previous vitreoretinal surgery, filtration surgery, and cataract surgery within 3 months in the study eye
- Note: Other inclusion/exclusion criteria apply
Key Trial Info
Start Date :
February 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2022
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT04746963
Start Date
February 1 2021
End Date
October 1 2022
Last Update
March 22 2024
Active Locations (10)
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1
AsclepiX Investigative Site
Gilbert, Arizona, United States, 85053
2
AsclepiX Investigative Site
Los Angeles, California, United States, 90211
3
AsclepiX Investigative Site
St. Petersburg, Florida, United States, 33711
4
AsclepiX Investigative Site
Boston, Massachusetts, United States, 02114