NCT04746963

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

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

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: AsclepiX Therapeutics, Inc. · Industry
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

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.

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). The first 3 eligible subjects will receive the low dose of AXT107 injection. After the 3 low dose subjects complete a 7-day follow-up, the DMC will review their safety data. If an acceptable safety profile is determined by the DMC, 3 additional subjects will be enrolled to receive the mid dose of AXT107 injection. Upon completion of a 7-day follow-up, review of the safety data, and determination of an acceptable safety profile by the DMC for the mid dose subjects, 3 additional subjects will be enrolled to receive the high dose of AXT107 injection.

Conditions

• Neovascular Age-Related Macular Degeneration (nAMD)

Interventions

Type	Name	Description
DRUG	AXT107 0.1 mg	Single intravitreal injection of AXT107 0.1 mg/eye (low dose)
DRUG	AXT107 0.25 mg	Single intravitreal injection of AXT107 0.25 mg/eye (mid dose)
DRUG	AXT107 0.5 mg	Single intravitreal injection of AXT107 0.5 mg/eye (high dose)

Timeline

• Start date: 2021-02-01
• Primary completion: 2022-10-01
• Completion: 2022-10-01
• First posted: 2021-02-10
• Last updated: 2024-03-22
• Results posted: 2024-03-22

Locations

10 sites across 1 country: United States

Regulatory

• FDA-regulated drug study