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Safety and Bioactivity of AXT107 in Subjects With Diabetic Macular Edema (CONGO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04697758
Recruitment Status : Recruiting
First Posted : January 6, 2021
Last Update Posted : February 21, 2021
Sponsor:
Information provided by (Responsible Party):
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).

Condition or disease Intervention/treatment Phase
Diabetic Macular Edema (DME) Drug: AXT107 0.1 mg Drug: AXT107 0.25 mg Drug: AXT107 0.5 mg Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 18 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 1/2a Study of the Safety and Bioactivity of AXT-107 in Subjects With Diabetic Macular Edema (DME)
Actual Study Start Date : December 10, 2020
Estimated Primary Completion Date : May 1, 2022
Estimated Study Completion Date : May 1, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema

Arm Intervention/treatment
Experimental: Low Dose
AXT107 0.1 mg/eye
Drug: AXT107 0.1 mg
Single intravitreal injection of AXT107 0.1 mg/eye

Experimental: Mid Dose
AXT107 0.25 mg/eye
Drug: AXT107 0.25 mg
Single intravitreal injection of AXT107 0.25 mg/eye

Experimental: High Dose
AXT107 0.5 mg/eye
Drug: AXT107 0.5 mg
Single intravitreal injection of AXT107 0.5 mg/eye




Primary Outcome Measures :
  1. Safety as Assessed by Incidence of Adverse Events (AEs) [ Time Frame: Screening to Week 48 ]
    Incidence of ocular (study eye) and systemic AEs


Secondary Outcome Measures :
  1. Efficacy as Assessed by Central Retinal Thickness (CST) [ Time Frame: Day 0 to Week 48 ]
    Mean change in CST assessed by spectral domain optical coherence tomography

  2. Efficacy as Assessed by Early Treatment Diabetic Retinopathy Study (ETDRS) Chart [ Time Frame: Day 0 to Week 48 ]
    Mean change in BCVA

  3. Efficacy as Assessed by Early Treatment Diabetic Retinopathy Study (ETDRS) Chart [ Time Frame: Day 0 to Week 48 ]
    Percentage of subjects improving ≥5, ≥10, and ≥15 letters in BCVA



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04697758


Contacts
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Contact: CMO of AsclepiX 800-572-3545 info@asclepix.com

Locations
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United States, Arizona
AsclepiX Investigative Site Recruiting
Gilbert, Arizona, United States, 85053
United States, California
AsclepiX Investigative Site Recruiting
Los Angeles, California, United States, 90211
United States, Florida
AsclepiX Investigative Site Recruiting
Saint Petersburg, Florida, United States, 33711
United States, Massachusetts
AsclepiX Investigative Site Recruiting
Boston, Massachusetts, United States, 02114
United States, Nevada
AsclepiX Investigative Site Recruiting
Reno, Nevada, United States, 89502
United States, Oregon
AsclepiX Investigative Site Recruiting
Eugene, Oregon, United States, 97401
United States, Pennsylvania
AsclepiX Investigative Site Not yet recruiting
Philadelphia, Pennsylvania, United States, 19107
United States, Texas
AsclepiX Investigative Site Recruiting
Abilene, Texas, United States, 79606
AsclepiX Investigative Site Recruiting
McAllen, Texas, United States, 78550
AsclepiX Investigative Site Recruiting
The Woodlands, Texas, United States, 77384
Sponsors and Collaborators
AsclepiX Therapeutics, Inc.
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Responsible Party: AsclepiX Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT04697758    
Other Study ID Numbers: AXT107-CS101
First Posted: January 6, 2021    Key Record Dates
Last Update Posted: February 21, 2021
Last Verified: February 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by AsclepiX Therapeutics, Inc.:
AsclepiX
macular edema
DME
eye diseases
retinal diseases
AXT107
diabetes
duration of action
dose escalation
diabetic retinopathy
retinal degeneration
Additional relevant MeSH terms:
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Macular Edema
Edema
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases