Safety and Bioactivity of AXT107 in Subjects With Diabetic Macular Edema

• Status: Recruiting
• Trial end date: 2022-05-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AsclepiX Therapeutics, Inc.

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.