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

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: NCT04746963
Recruitment Status : Recruiting
First Posted : February 10, 2021
Last Update Posted : March 24, 2021
Sponsor:
Information provided by (Responsible Party):
AsclepiX Therapeutics, Inc.

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Neovascular Age-Related Macular Degeneration (nAMD) Drug: AXT107 0.1 mg Drug: AXT107 0.25 mg Drug: AXT107 0.5 mg Phase 1 Phase 2

Study Design
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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 AXT107 in Subjects With Neovascular Age-Related Macular Degeneration (nAMD)
Actual Study Start Date : February 1, 2021
Estimated Primary Completion Date : August 1, 2022
Estimated Study Completion Date : August 1, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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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 (low dose)
Experimental: Mid Dose
AXT107 0.25 mg/eye
 Drug: AXT107 0.25 mg
Single intravitreal injection of AXT107 0.25 mg/eye (mid dose)
Experimental: High Dose
AXT107 0.5 mg/eye
 Drug: AXT107 0.5 mg
Single intravitreal injection of AXT107 0.5 mg/eye (high dose)


Outcome Measures
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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 (EDTRS) Chart [ Time Frame: Day 0 to Week 48 ]
    Mean change in Best Corrected Visual Acuity (BCVA)

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


Eligibility Criteria
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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Contacts and Locations
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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): NCT04746963


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 Recruiting
Huntingdon Valley, Pennsylvania, United States, 19006
United States, Texas
AsclepiX Investigative Site Recruiting
Abilene, Texas, United States, 79606
AsclepiX Investigative Site Recruiting
McAllen, Texas, United States, 78503
AsclepiX Investigative Site Recruiting
The Woodlands, Texas, United States, 77384
Sponsors and Collaborators
AsclepiX Therapeutics, Inc.
More Information
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Responsible Party: AsclepiX Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT04746963    
Other Study ID Numbers: AXT107-CS102
First Posted: February 10, 2021    Key Record Dates
Last Update Posted: March 24, 2021
Last Verified: March 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
Neovascular Age-Related Macular Degeneration
nAMD
eye diseases
retinal diseases
 AXT107
duration of action
dose escalation
macular degeneration
Additional relevant MeSH terms:
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Macular Degeneration
Wet Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases