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

March 20, 2024 updated by: AsclepiX Therapeutics, Inc.

Phase 1/2a Study of the Safety and Bioactivity of AXT107 in Subjects With Neovascular Age-Related Macular Degeneration (nAMD)

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

3

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Gilbert, Arizona, United States, 85053
        • AsclepiX Investigative Site
    • California
      • Los Angeles, California, United States, 90211
        • AsclepiX Investigative Site
    • Florida
      • Saint Petersburg, Florida, United States, 33711
        • AsclepiX Investigative Site
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • AsclepiX Investigative Site
    • Nevada
      • Reno, Nevada, United States, 89502
        • AsclepiX Investigative Site
    • Oregon
      • Eugene, Oregon, United States, 97401
        • AsclepiX Investigative Site
    • Pennsylvania
      • Huntingdon Valley, Pennsylvania, United States, 19006
        • AsclepiX Investigative Site
    • Texas
      • Abilene, Texas, United States, 79606
        • AsclepiX Investigative Site
      • McAllen, Texas, United States, 78503
        • AsclepiX Investigative Site
      • The Woodlands, Texas, United States, 77384
        • AsclepiX Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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)
Other Names:
  • Gersizangatide
Experimental: Mid Dose
AXT107 0.25 mg/eye
Drug: AXT107 0.25 mg
Single intravitreal injection of AXT107 0.25 mg/eye (mid dose)
Other Names:
  • Gersizangatide
Experimental: High Dose
AXT107 0.5 mg/eye
Drug: AXT107 0.5 mg
Single intravitreal injection of AXT107 0.5 mg/eye (high dose)
Other Names:
  • Gersizangatide

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants Assessed by Incidence of Adverse Events (AEs)
Time Frame: Screening to Week 48
Incidence of ocular (study eye) and systemic adverse events (AEs)
Screening to Week 48

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Day 0 to Week 48
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)
Day 0 to Week 48
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)
Day 0 to Week 48

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AsclepiX Therapeutics, Inc.

Investigators

  • Study Director: Amir Shojaei, PhD, Asclepix Therapeutics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2021

Primary Completion (Actual)

October 1, 2022

Study Completion (Actual)

October 1, 2022

Study Registration Dates

First Submitted

February 5, 2021

First Submitted That Met QC Criteria

February 9, 2021

First Posted (Actual)

February 10, 2021

Study Record Updates

Last Update Posted (Actual)

March 22, 2024

Last Update Submitted That Met QC Criteria

March 20, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AXT107-CS102

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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