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

March 18, 2024 updated by: AsclepiX Therapeutics, Inc.

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

The goal of this clinical trial is to understand the safety of AXT107 injected suprachoroidally in participants with nAMD. The main question[s] it aims to answer are:

  • Safety of the maximum tolerable dose of AXT107
  • Bioactivity and duration of action of AXT107 injected suprachoroidally Participants will be injected with AXT107 and will be followed on a regular monitoring visits through 9 months post single injection.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

15

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 Contact

Study Locations

  • United States
    • Massachusetts
      • Springfield, Massachusetts, United States, 01107
        • Recruiting
        • New England Retina Consultants
        • Contact:
          • Mary French
    • Missouri
      • Saint Louis, Missouri, United States, 63128
        • Recruiting
        • The Retina Institue
        • Contact:
          • Lauren MacDonald-Mueller
    • North Carolina
      • Asheville, North Carolina, United States, 28803
        • Recruiting
        • Asheville Eye Associates
        • Contact:
          • Hailey Emory
    • Pennsylvania
      • Erie, Pennsylvania, United States, 16507
        • Recruiting
        • Erie Retina Research
        • Contact:
          • David Almeida, MD
          • Phone Number: 814-200-9152
          • Email: drpa@pm.me

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 50 years of age or older
  • Presence of active subfoveal choroidal neovascularization (CNV) (any subtype) or juxtafoveal CNV with leakage affecting the fovea secondary to AMD and the area of the CNV lesion must beat least 50% of the total lesion size confirmed by the Investigator
  • Evidence of subretinal or intraretinal fluid or retinal cystic changes evidenced by Spectral Domain Optical Coherence Tomography (SD-OCT) at Screening accompanied by finding on SD- OCT suggestive of CNV secondary to AMD confirmed by the Investigator
  • BCVA in the study eye between 65 and 25 ETDRS letters (20/50 and 20/320 Snellen equivalent) at Baseline (Day 0)
  • BCVA of 34 ETDRS letters or better (20/200 or better Snellen equivalent) in the non-study eye at Baseline (Day 0)
  • Able and willing to give signed informed consent and follow study instructions
  • Has been/is a prior partial responder to an anti-VEGF agent

Exclusion Criteria:

  • Previously treated patients who are non-responders to anti-VEGF as determined by the Investigator
  • Any prior use of Brolucizumab; use of Aflibercept within 8 weeks or use of Ranibizumab or Bevacizumab within 6 weeks from Baseline (Day 0) in the study eye
  • Any concurrent disease that would require medical or surgical intervention during the study in the study eye (e.g., retinal detachment, significant cataract)
  • Any condition that may preclude improvement in visual acuity or affect the evaluation of the study eye after resolution of AMD (e.g., extensive macular hemorrhage ≥ 50% lesion size, media clarity insufficient to obtain quality images, presence of diabetic retinopathy)
  • Other causes of CNV (e.g., pathologic myopia, ocular histoplasmosis syndrome, angioid streaks, and multifocal choroiditis) in the study eye confirmed by the Investigator
  • Chronic uveitis or ongoing clinically significant infection or inflammation (e.g., keratitis, scleritis) in either eye

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 0.125 mg/eye
Drug: AXT107 Low Dose
Single suprachoroidal injection of AXT107 (0.125 mg/eye)
Other Names:
  • Gersizangatide
Experimental: Mid Dose
AXT107 0.250 mg/eye
Drug: AXT107 Mid Dose
Single suprachoroidal injection of AXT107 (0.250 mg/eye)
Other Names:
  • Gersizangatide
Experimental: High Dose
AXT107 0.500 mg/eye
Drug: AXT107 High Dose
Single suprachoroidal injection of AXT107 (0.500 mg/eye)
Other Names:
  • Gersizangatide

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Treatment-Emergent Adverse Events
Time Frame: 40 Weeks

Primary Outcome Measure:

1.Safety as Assessed by change from baseline in Incidence of Adverse Events (AEs) Incidence of ocular (study eye) and systemic AEs

[Time Frame: Screening to Week 40]
40 Weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean Change in Central Subfield Thickness (CST)
Time Frame: 40 Weeks

Secondary Outcome Measures:

Efficacy as Assessed by Central Subfield Thickness (CST, measured in µm) Mean change in CST assessed by spectral domain optical coherence tomography

[Time Frame: Day 0 to Week 40]
40 Weeks
Mean Change in Visual Function
Time Frame: Day 0 to Week 40

Secondary Outcome Measures:

Visual Function as Assessed by Mean change in Best Corrected Visual Acuity (BCVA) (number of letters in Early Treatment Diabetic Retinopathy Study (EDTRS) chart)
Day 0 to Week 40
Visual Function Subgroup Analysis
Time Frame: Day 0 to Week 40

Secondary Outcome Measures:

Visual Function as Assessed by Early Treatment Diabetic Retinopathy Study (EDTRS) Chart Percentage of subjects improving ≥5, ≥10, and ≥15 letters in Best Corrected Visual Acuity (BCVA)
Day 0 to Week 40

Collaborators and Investigators

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

Sponsor

AsclepiX Therapeutics, Inc.

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)

December 19, 2023

Primary Completion (Estimated)

February 1, 2025

Study Completion (Estimated)

April 1, 2025

Study Registration Dates

First Submitted

March 24, 2023

First Submitted That Met QC Criteria

May 5, 2023

First Posted (Actual)

May 16, 2023

Study Record Updates

Last Update Posted (Actual)

March 19, 2024

Last Update Submitted That Met QC Criteria

March 18, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AXT107-CS104

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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