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Anti-VEGF Antibody

AXT107 for Age-Related Macular Degeneration (DISCOVER Trial)

Phase 1 & 2
Waitlist Available
Research Sponsored by AsclepiX Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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)
50 years of age or older
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 40 weeks
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing the safety of a drug called AXT107 when injected into the eye of people with a certain eye condition. The trial will also look at how long the drug stays active in the

Who is the study for?
This trial is for people over 50 with a type of vision loss called nAMD. They must have certain types of eye fluid or changes seen on an eye scan, and their vision should be within a specific range. Participants also need to have had some response to previous treatments that target VEGF, a protein related to blood vessel growth.
What is being tested?
The study tests three doses of AXT107 given as an injection into the eye area in patients with nAMD. It aims to find out how safe the drug is at its highest dose that can be tolerated and how well it works over nine months after just one injection.
What are the potential side effects?
While not explicitly listed here, potential side effects may include discomfort or complications from the injection process itself, inflammation inside the eye, increased intraocular pressure, and possible impact on visual acuity.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have AMD with specific vision loss and confirmed CNV affecting my central vision.
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I am 50 years old or older.
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I previously had some response to anti-VEGF treatment.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~40 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 40 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Incidence of Treatment-Emergent Adverse Events
Secondary study objectives
Mean Change in Central Subfield Thickness (CST)
Mean Change in Visual Function
Visual Function Subgroup Analysis

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups
Experimental Treatment
Group I: Mid DoseExperimental Treatment1 Intervention
AXT107 0.250 mg/eye
Group II: Low DoseExperimental Treatment1 Intervention
AXT107 0.125 mg/eye
Group III: High DoseExperimental Treatment1 Intervention
AXT107 0.500 mg/eye

Find a Location

Who is running the clinical trial?

AsclepiX Therapeutics, Inc.Lead Sponsor
2 Previous Clinical Trials
9 Total Patients Enrolled
1 Trials studying Macular Degeneration
3 Patients Enrolled for Macular Degeneration
~2 spots leftby Mar 2025
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