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

Phase 1

Active, not recruiting

• Conditions: Neovascular Age-related Macular Degeneration
• Interventions: Drug: AXT107 Low Dose; Drug: AXT107 Mid Dose; Drug: AXT107 High Dose

• Registration Number: NCT05859776
• Lead Sponsor: AsclepiX Therapeutics, Inc.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-03-24
• Study First Submitted QC: 2023-05-05
• Study First Posted: 2023-05-16
• Study Start: 2023-12-19
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-03
• Last Update Posted: 2024-05-06
• Primary Completion: 2025-03
• Study Completion: 2025-05

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 15

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Low Dose	AXT107 Low Dose	AXT107 0.125 mg/eye
Mid Dose	AXT107 Mid Dose	AXT107 0.250 mg/eye
High Dose	AXT107 High Dose	AXT107 0.500 mg/eye

Primary Outcome Measures

Name	Time	Method
Incidence of Treatment-Emergent Adverse Events	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; \[Time Frame: Screening to Week 40\]

Secondary Outcome Measures

Name	Time	Method
Mean Change in Central Subfield Thickness (CST)	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; \[Time Frame: Day 0 to Week 40\]
Visual Function Subgroup Analysis	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)
Mean Change in Visual Function	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)

Trial Locations

Locations (4)

Erie Retina Research; 🇺🇸 Erie, Pennsylvania, United States

New England Retina Consultants; 🇺🇸 Springfield, Massachusetts, United States

The Retina Institue; 🇺🇸 Saint Louis, Missouri, United States

Asheville Eye Associates; 🇺🇸 Asheville, North Carolina, United States