NCT05859776

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

Phase 1/2a Study of the Safety and Bioactivity of AXT107 Injected Suprachoroidally in Subjects With Neovascular Age-Related Macular Degeneration (nAMD)

• Status: Active Not Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: AsclepiX Therapeutics, Inc. · Industry
• Sex: All
• Age: 50 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to understand the safety of AXT107 injected suprachoroidally in participants with nAMD. The main question\[s\] it aims to answer are: * Safety of the maximum tolerable dose of AXT107 * Bioactivity and duration of action of AXT107 injected suprachoroidally Participants will be injected with AXT107 and will be followed on a regular monitoring visits through 9 months post single injection.

Conditions

• Neovascular Age-related Macular Degeneration

Interventions

Type	Name	Description
DRUG	AXT107 Low Dose	Single suprachoroidal injection of AXT107 (0.125 mg/eye)
DRUG	AXT107 Mid Dose	Single suprachoroidal injection of AXT107 (0.250 mg/eye)
DRUG	AXT107 High Dose	Single suprachoroidal injection of AXT107 (0.500 mg/eye)

Timeline

• Start date: 2023-12-19
• Primary completion: 2025-03-01
• Completion: 2025-05-01
• First posted: 2023-05-16
• Last updated: 2024-05-06

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study