Safety and Bioactivity of AXT107 in Subjects With Diabetic Macular Edema

Diabetic Macular Edema (DME) Clinical Trial

— CONGO  

Official title:

Phase 1/2a Study of the Safety and Bioactivity of AXT-107 in Subjects With Diabetic Macular Edema (DME)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04697758
• Other study ID #: AXT107-CS101
• Status: Terminated
• Phase: Phase 1/Phase 2
• 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
• 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.

Related Conditions & MeSH terms

• Diabetic Macular Edema (DME)
• Edema
• Macular Edema

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