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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT04697758
Other study ID # AXT107-CS101
Secondary ID
Status Terminated
Phase Phase 1/Phase 2
First received
Last updated
Start date December 10, 2020
Est. completion date October 1, 2022

Study information

Verified date March 2024
Source AsclepiX Therapeutics, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


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). The first 3 eligible subjects will receive the low dose of AXT107 injection. After the 3 low dose subjects complete a 7-day follow-up, the DMC will review their safety data. If an acceptable safety profile is determined by the DMC, 3 additional subjects will be enrolled to receive the mid dose of AXT107 injection. Upon completion of a 7-day follow-up, review of the safety data, and determination of an acceptable safety profile by the DMC for the mid dose subjects, 3 additional subjects will be enrolled to receive the high dose of AXT107 injection.


Recruitment information / eligibility

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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
AXT107 0.1 mg
Single intravitreal injection of AXT107 0.1 mg/eye
AXT107 0.25 mg
Single intravitreal injection of AXT107 0.25 mg/eye
AXT107 0.5 mg
Single intravitreal injection of AXT107 0.5 mg/eye

Locations

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

Sponsors (1)

Lead Sponsor Collaborator
AsclepiX Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

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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