Safety and Bioactivity of AXT107 in Subjects With Diabetic Macular Edema

Phase 1

Terminated

• Conditions: Diabetic Macular Edema (DME)
• Interventions: Drug: AXT107 0.25 mg; Drug: AXT107 0.5 mg; Drug: AXT107 0.1 mg

• Registration Number: NCT04697758
• Lead Sponsor: AsclepiX Therapeutics, Inc.

Brief 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).

Detailed 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.

Study Timeline

• Study Start: 2020-12-10
• Study First Submitted: 2020-12-17
• Study First Submitted QC: 2021-01-04
• Study First Posted: 2021-01-06
• Primary Completion: 2022-10-01
• Study Completion: 2022-10-01
• Results First Submitted: 2024-01-29
• Status Verified: 2024-03
• Results First Submitted QC: 2024-03-20
• Last Update Submitted: 2024-03-20
• Results First Posted: 2024-03-22
• Last Update Posted: 2024-03-22

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 6

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

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Mid Dose	AXT107 0.25 mg	AXT107 0.25 mg/eye
High Dose	AXT107 0.5 mg	AXT107 0.5 mg/eye
Low Dose	AXT107 0.1 mg	AXT107 0.1 mg/eye

Primary Outcome Measures

Name	Time	Method
Safety as Assessed by Incidence of Adverse Events (AEs)	Screening to Week 48	Incidence of ocular (study eye) and systemic AEs

Trial Locations

Locations (1)

AsclepiX Investigative Site; 🇺🇸 The Woodlands, Texas, United States