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 Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
15
Single suprachoroidal injection of AXT107 (0.125 mg/eye)
Single suprachoroidal injection of AXT107 (0.250 mg/eye)
Single suprachoroidal injection of AXT107 (0.500 mg/eye)
New England Retina Consultants
Springfield, Massachusetts, United States
The Retina Institue
St Louis, Missouri, United States
Asheville Eye Associates
Asheville, North Carolina, United States
Erie Retina Research
Erie, Pennsylvania, United States
Incidence of Treatment-Emergent Adverse Events
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 \[Time Frame: Screening to Week 40\]
Time frame: 40 Weeks
Mean Change in Central Subfield Thickness (CST)
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 \[Time Frame: Day 0 to Week 40\]
Time frame: 40 Weeks
Mean Change in Visual Function
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)
Time frame: Day 0 to Week 40
Visual Function Subgroup Analysis
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)
Time frame: Day 0 to Week 40
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