Diabetic Macular Edema (DME) Clinical Trial
— CONGOOfficial title:
Phase 1/2a Study of the Safety and Bioactivity of AXT-107 in Subjects With Diabetic Macular Edema (DME)
Verified date | March 2024 |
Source | AsclepiX Therapeutics, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
Status | Terminated |
Enrollment | 6 |
Est. completion date | October 1, 2022 |
Est. primary completion date | October 1, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | AsclepiX Investigative Site | Abilene | Texas |
United States | AsclepiX Investigative Site | Boston | Massachusetts |
United States | AsclepiX Investigative Site | Eugene | Oregon |
United States | AsclepiX Investigative Site | Gilbert | Arizona |
United States | AsclepiX Investigative Site | Los Angeles | California |
United States | AsclepiX Investigative Site | McAllen | Texas |
United States | AsclepiX Investigative Site | Philadelphia | Pennsylvania |
United States | AsclepiX Investigative Site | Reno | Nevada |
United States | AsclepiX Investigative Site | Saint Petersburg | Florida |
United States | AsclepiX Investigative Site | The Woodlands | Texas |
Lead Sponsor | Collaborator |
---|---|
AsclepiX Therapeutics, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Safety as Assessed by Incidence of Adverse Events (AEs) | Incidence of ocular (study eye) and systemic AEs | Screening to Week 48 |
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