Safety and Bioactivity of AXT107 in Subjects With Neovascular Age-Related Macular Degeneration (nAMD)
NCT ID: NCT05859776
Last Updated: 2024-05-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE1/PHASE2
15 participants
INTERVENTIONAL
2023-12-19
2025-05-31
Brief Summary
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* 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.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Low Dose
AXT107 0.125 mg/eye
AXT107 Low Dose
Single suprachoroidal injection of AXT107 (0.125 mg/eye)
Mid Dose
AXT107 0.250 mg/eye
AXT107 Mid Dose
Single suprachoroidal injection of AXT107 (0.250 mg/eye)
High Dose
AXT107 0.500 mg/eye
AXT107 High Dose
Single suprachoroidal injection of AXT107 (0.500 mg/eye)
Interventions
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AXT107 Low Dose
Single suprachoroidal injection of AXT107 (0.125 mg/eye)
AXT107 Mid Dose
Single suprachoroidal injection of AXT107 (0.250 mg/eye)
AXT107 High Dose
Single suprachoroidal injection of AXT107 (0.500 mg/eye)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
50 Years
99 Years
ALL
No
Sponsors
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AsclepiX Therapeutics, Inc.
INDUSTRY
Responsible Party
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Locations
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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
Countries
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Other Identifiers
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AXT107-CS104
Identifier Type: -
Identifier Source: org_study_id
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