Status:
TERMINATED
Safety and Bioactivity of AXT107 in Subjects With Diabetic Macular Edema
Lead Sponsor:
AsclepiX Therapeutics, Inc.
Conditions:
Diabetic Macular Edema (DME)
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief 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 AXT1...
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)....
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 10 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2022
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT04697758
Start Date
December 10 2020
End Date
October 1 2022
Last Update
March 22 2024
Active Locations (10)
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1
AsclepiX Investigative Site
Gilbert, Arizona, United States, 85053
2
AsclepiX Investigative Site
Los Angeles, California, United States, 90211
3
AsclepiX Investigative Site
St. Petersburg, Florida, United States, 33711
4
AsclepiX Investigative Site
Boston, Massachusetts, United States, 02114