AXT107 for Age-Related Macular Degeneration (DISCOVER Trial)

Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: AsclepiX Therapeutics, Inc.

No Placebo Group

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.

I am 50 years old or older.

I previously had some response to anti-VEGF treatment.

Treatment Details

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.

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