AXT107 for Age-Related Macular Degeneration

(DISCOVER Trial)

Recruiting at 3 trial locations

Overseen By Amanda Boillino, RN

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: AsclepiX Therapeutics, Inc.

Must be taking: Anti-VEGF

Must not be taking: Brolucizumab, Aflibercept, Ranibizumab, Bevacizumab

Disqualifiers: Non-responders, Retinal detachment, Diabetic retinopathy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1 day

15 Participants Needed

Trial Summary

What is the purpose of this trial?

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

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.

Inclusion Criteria

I have AMD with specific vision loss and confirmed CNV affecting my central vision.

Your non-study eye has vision of 20/200 or better on a vision chart.

I am 50 years old or older.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single injection of AXT107 suprachoroidally

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and bioactivity of AXT107 through regular visits

9 months

Regular monitoring visits

Treatment Details

Interventions

• AXT107 High Dose
• AXT107 Low Dose
• AXT107 Mid Dose

Trial Overview 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.

Participant Groups

Group I: Mid Dose Experimental Treatment 1 Intervention

AXT107 0.250 mg/eye

Group II: Low Dose Experimental Treatment 1 Intervention

AXT107 0.125 mg/eye

Group III: High Dose Experimental Treatment 1 Intervention

AXT107 0.500 mg/eye

Who Is Running the Clinical Trial?

AsclepiX Therapeutics, Inc.

Lead Sponsor

Trials

3

Recruited

20+