Safety and Bioactivity of AXT107 in Subjects With Diabetic Macular Edema
NCT ID: NCT04697758
Last Updated: 2024-03-22
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE1/PHASE2
6 participants
INTERVENTIONAL
2020-12-10
2022-10-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Low Dose
AXT107 0.1 mg/eye
AXT107 0.1 mg
Single intravitreal injection of AXT107 0.1 mg/eye
Mid Dose
AXT107 0.25 mg/eye
AXT107 0.25 mg
Single intravitreal injection of AXT107 0.25 mg/eye
High Dose
AXT107 0.5 mg/eye
AXT107 0.5 mg
Single intravitreal injection of AXT107 0.5 mg/eye
Interventions
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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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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AsclepiX Therapeutics, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Amir Shojaei, PhD
Role: STUDY_DIRECTOR
Asclepix Therapeutics
Locations
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AsclepiX Investigative Site
Gilbert, Arizona, United States
AsclepiX Investigative Site
Los Angeles, California, United States
AsclepiX Investigative Site
St. Petersburg, Florida, United States
AsclepiX Investigative Site
Boston, Massachusetts, United States
AsclepiX Investigative Site
Reno, Nevada, United States
AsclepiX Investigative Site
Eugene, Oregon, United States
AsclepiX Investigative Site
Philadelphia, Pennsylvania, United States
AsclepiX Investigative Site
Abilene, Texas, United States
AsclepiX Investigative Site
McAllen, Texas, United States
AsclepiX Investigative Site
The Woodlands, Texas, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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AXT107-CS101
Identifier Type: -
Identifier Source: org_study_id
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