Safety and Bioactivity of AXT107 in Subjects With Neovascular Age-Related Macular Degeneration

Neovascular Age-Related Macular Degeneration (nAMD) Clinical Trial

— SHASTA  

Official title:

Phase 1/2a Study of the Safety and Bioactivity of AXT107 in Subjects With Neovascular Age-Related Macular Degeneration (nAMD)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04746963
• Other study ID #: AXT107-CS102
• Status: Terminated
• Phase: Phase 1/Phase 2
• Start date: February 1, 2021
• 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 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 nAMD.

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: 3
• Est. completion date: October 1, 2022
• Est. primary completion date: October 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

• Patients 50 years of age or older diagnosed in the study eye with subfoveal choroidal neovascularization (CNV) or juxtafoveal CNV secondary to AMD
• Best corrected visual acuity (BCVA) Early Treatment Diabetic Retinopathy Study (ETDRS) letter score of 65 to 10 in the study eye
• Willing and able to comply with clinic visits and study-related procedures
• Provide signed inform consent

Exclusion Criteria:

• Macular edema or CMV secondary to any causes other than AMD in the study eye
• Previously-treated patients who are not responders to anti-VEGF
• Any condition that may preclude improvement in visual acuity in the study eye
• Previous vitreoretinal surgery, filtration surgery, and cataract surgery within 3 months in the study eye Note: Other inclusion/exclusion criteria apply

Related Conditions & MeSH terms

• Macular Degeneration
• Neovascular Age-Related Macular Degeneration (nAMD)
• Wet Macular Degeneration

Intervention

Drug:
• AXT107 0.1 mg
Single intravitreal injection of AXT107 0.1 mg/eye (low dose)
• AXT107 0.25 mg
Single intravitreal injection of AXT107 0.25 mg/eye (mid dose)
• AXT107 0.5 mg
Single intravitreal injection of AXT107 0.5 mg/eye (high dose)

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	Huntingdon Valley	Pennsylvania
United States	AsclepiX Investigative Site	Los Angeles	California
United States	AsclepiX Investigative Site	McAllen	Texas
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	Number of Participants Assessed by Incidence of Adverse Events (AEs)	Incidence of ocular (study eye) and systemic adverse events (AEs)	Screening to Week 48