Clinical trial NCT05859776: Safety and Bioactivity of AXT107 in Subjects With Neovascular Age-Related Macular Degeneration (nAMD)
Official title: Phase 1/2a Study of the Safety and Bioactivity of AXT107 Injected Suprachoroidally in Subjects With Neovascular Age-Related Macular Degeneration (nAMD)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
PHASE2
Conditions: Neovascular Age-related Macular Degeneration
Lead sponsor: AsclepiX Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2023-05-16
Enrollment: 15
Sex: ALL
Minimum age (years): 50
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Incidence of Treatment-Emergent Adverse Events
timeFrame: 40 Weeks
Secondary outcomes:
measure: Mean Change in Central Subfield Thickness (CST)
timeFrame: 40 Weeks
measure: Mean Change in Visual Function
timeFrame: Day 0 to Week 40
measure: Visual Function Subgroup Analysis
timeFrame: Day 0 to Week 40
Other outcomes:
Locations:
city: Springfield
country: United States
facility: New England Retina Consultants
state: Massachusetts
city: Saint Louis
country: United States
facility: The Retina Institue
state: Missouri
city: Asheville
country: United States
facility: Asheville Eye Associates
state: North Carolina
city: Erie
country: United States
facility: Erie Retina Research
state: Pennsylvania
Study officials:
References: