Safety and Bioactivity of AXT107 in Subjects With Neovascular Age-Related Macular Degeneration

Stopped early · Phase 1/Phase 2

Conditions studied: Neovascular Age-Related Macular Degeneration (nAMD)

In brief

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 approximately 18 subjects (up to 6 subjects per dose) with nAMD.

Key facts

Study ID

NCT04746963

Run by

AsclepiX Therapeutics, Inc.

People needed

3

Starts

2021-02-01

Expected to finish

2022-10-01

Last updated by the study team

2024-03-22

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• AsclepiX Investigative Site — Gilbert, Arizona, United States
• AsclepiX Investigative Site — Los Angeles, California, United States
• AsclepiX Investigative Site — St. Petersburg, Florida, United States
• AsclepiX Investigative Site — Boston, Massachusetts, United States
• AsclepiX Investigative Site — Reno, Nevada, United States
• AsclepiX Investigative Site — Eugene, Oregon, United States
• AsclepiX Investigative Site — Huntingdon Valley, Pennsylvania, United States
• AsclepiX Investigative Site — Abilene, Texas, United States
• AsclepiX Investigative Site — McAllen, Texas, United States
• AsclepiX Investigative Site — The Woodlands, Texas, United States

Full record on ClinicalTrials.gov

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