NCT04697758

Safety and Bioactivity of AXT107 in Subjects With Diabetic Macular Edema

Phase 1/2a Study of the Safety and Bioactivity of AXT-107 in Subjects With Diabetic Macular Edema (DME)

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: AsclepiX Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study 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 Diabetic Macular Edema (DME).

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

• Diabetic Macular Edema (DME)

Interventions

Type	Name	Description
DRUG	AXT107 0.1 mg	Single intravitreal injection of AXT107 0.1 mg/eye
DRUG	AXT107 0.25 mg	Single intravitreal injection of AXT107 0.25 mg/eye
DRUG	AXT107 0.5 mg	Single intravitreal injection of AXT107 0.5 mg/eye

Timeline

• Start date: 2020-12-10
• Primary completion: 2022-10-01
• Completion: 2022-10-01
• First posted: 2021-01-06
• Last updated: 2024-03-22
• Results posted: 2024-03-22

Locations

10 sites across 1 country: United States

Regulatory

• FDA-regulated drug study