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Study Overview

Wet age-related macular degeneration (wAMD) is a leading cause of vision loss in individuals age 50 years or older. This study explores an investigational drug named EYP-1901 that is designed to potentially block the proteins that cause wAMD. This study is investigating the study drug (EYP-1901) to find out how safe and effective it is compared to aflibercept (an approved treatment for individuals with wAMD). This clinical research study will help researchers learn:

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    How safe EYP-1901 is compared to aflibercept

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    How effective EYP-1901 is compared to aflibercept

Who Can Join!

To participate in the LUGANO clinical research study, you must:

  • Be at least 50 years of age or older

  • Be diagnosed with wAMD

  • Not have had cataract surgery in the last 12 weeks

  • Not have had corneal transplant surgery

This is not a complete list of study requirements. The study doctor will review the full requirements for this study with you.

What to Expect?

You will be in this clinical research study for approximately 99 weeks (about 2 years), and you will be asked to visit the study center at least 26 times over this period. Eye examinations and imaging, laboratory tests, and other assessments will be conducted as part of this study.

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Screening Period (up to 21 days)

  • Participants’ eligibility will be assessed during screening. This may include: o Review of demographic, medical history, and participants’ medications o Vital signs, such as heart rate & blood pressure o Eye examinations required per LUGANO protocol o Review of the informed consent o Blood tests
  • A written informed consent must be obtained before beginning any trial-related procedures.
  • This is not a complete list of screening procedures. The study doctor will review all screening procedures together with you.

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    Study Treatment Period and Follow-Up Period (up to 96 weeks)

  • Those who pass the screening period and are eligible to participate in the LUGANO study will return for their first study visit, considered their “Baseline Visit” or Day 1 visit. At this visit, you will be randomly assigned (by chance) to one of the two treatment groups for the remainder of the study: EYP-1901 or aflibercept, also known as EYLEA®.
  • You will have a 50% (1 in 2) chance of being assigned to the EYP-1901 treatment group and a 50% (1 in 2) chance of being assigned to the aflibercept treatment group. EYP-1901 (study drug) and aflibercept will be administered and re-administered via intravitreal (IVT) injection into the designated study eye at specified visits.
  • Participants assigned to the EYP-1901 treatment group will receive their first EYP-1901 treatment at the Week 8 study visit per the LUGANO protocol.
  • Eligible participants who are enrolled will have scheduled study visits over approximately 96 weeks.

    • Created by StudyKIK