Safety and Bioactivity of AXT107 in Subjects With Diabetic Macular Edema

Stopped early · Phase 1/Phase 2

Conditions studied: Diabetic Macular Edema (DME)

In brief

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).

Key facts

Study ID

NCT04697758

Run by

AsclepiX Therapeutics, Inc.

People needed

6

Starts

2020-12-10

Expected to finish

2022-10-01

Last updated by the study team

2024-03-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients 18 years of age or older with diabetic macular edema (DME) diagnosis secondary to diabetes mellitus Type 1 or 2
• Best corrected visual acuity (BCVA) Early Treatment Diabetic Retinopathy Study (ETDRS) letter score of 65 to 23 in the study eye
• Willing and able to comply with clinic visits and study-related procedures
• Provide signed inform consent

You may not qualify if…

• Any signs of high risk proliferative diabetic retinopathy in the study
• Previously-treated patients who are not responders to anti-VEGF
• Panretinal laser photocoagulation within 6 months and macular laser photocoagulation with 3 months of screening in the study eye
• Note: Other inclusion/exclusion criteria apply.

Where it is running

• AsclepiX Investigative Site — Gilbert, Arizona, United States
• AsclepiX Investigative Site — Los Angeles, California, United States
• AsclepiX Investigative Site — St. Petersburg, Florida, United States
• AsclepiX Investigative Site — Boston, Massachusetts, United States
• AsclepiX Investigative Site — Reno, Nevada, United States
• AsclepiX Investigative Site — Eugene, Oregon, United States
• AsclepiX Investigative Site — Philadelphia, Pennsylvania, United States
• AsclepiX Investigative Site — Abilene, Texas, United States
• AsclepiX Investigative Site — McAllen, Texas, United States
• AsclepiX Investigative Site — The Woodlands, Texas, United States

Full record on ClinicalTrials.gov

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