drugset
drugset / Trial / NCT04697758

Safety and Bioactivity of AXT107 in Subjects With Diabetic Macular Edema

NCT04697758 ↗

Phase 1/2 Terminated 6 enrolled AsclepiX Therapeutics, Inc.
Non-randomizedSequentialOpen-labelTreatment

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).

Timeline

Start
2020-12-10
Primary completion
2022-10-01
Completion
2022-10-01

Outcome

Outcome not reported

Stopped: “Adverse Events”

Drugs

EvaluationDrugModalityDoseRoute
Subject GERSIZANGITIDE Protein / enzyme biologic 0.1 mg Intravitreal
Subject GERSIZANGITIDE Protein / enzyme biologic 0.25 mg Intravitreal
Subject GERSIZANGITIDE Protein / enzyme biologic 0.5 mg Intravitreal

Indications

diabetic macular edema