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

• Status: Recruiting
• Trial end date: 2022-08-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AsclepiX Therapeutics, Inc.

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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