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

Phase 2TerminatedNCT04746963

AsclepiX Therapeutics, Inc.3 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Neovascular Age-Related Macular Degeneration (nAMD)

Interventions

AXT107 0.1 mgDRUG

Single intravitreal injection of AXT107 0.1 mg/eye (low dose)

AXT107 0.25 mgDRUG

Single intravitreal injection of AXT107 0.25 mg/eye (mid dose)

AXT107 0.5 mgDRUG

Single intravitreal injection of AXT107 0.5 mg/eye (high dose)

Eligibility

Sex: ALLMin age: 50 Years

Medical Language ↔ Plain English

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

Locations (10)

AsclepiX Investigative Site

Gilbert, Arizona, United States

AsclepiX Investigative Site

Los Angeles, California, United States

AsclepiX Investigative Site

St. Petersburg, Florida, United States

Outcomes

Primary Outcomes

Number of Participants Assessed by Incidence of Adverse Events (AEs)

Incidence of ocular (study eye) and systemic adverse events (AEs)

Time frame: Screening to Week 48

Data from ClinicalTrials.gov

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