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Safety and Bioactivity of AXT107 in Subjects With Diabetic Macular Edema

NCT04697758 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2024-03-22

Study results available
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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).

Conditions

  • Diabetic Macular Edema (DME)

Interventions

DRUG

AXT107 0.1 mg

Single intravitreal injection of AXT107 0.1 mg/eye

DRUG

AXT107 0.25 mg

Single intravitreal injection of AXT107 0.25 mg/eye

DRUG

AXT107 0.5 mg

Single intravitreal injection of AXT107 0.5 mg/eye

Sponsors & Collaborators

  • AsclepiX Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • Amir Shojaei, PhD · Asclepix Therapeutics

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-10
Primary Completion
2022-10-01
Completion
2022-10-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04697758 on ClinicalTrials.gov