A 2-year Study of EYP-1901 in Subjects With Wet Age Related Macular Degeneration (wAMD) (LUGANO) Primary Efficacy Will be Determined at Week 56
Launched by EYEPOINT PHARMACEUTICALS, INC. · Oct 30, 2024
Trial Information
Current as of May 17, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial, called LUGANO, is studying a new treatment called EYP-1901 for people with wet age-related macular degeneration (wAMD). This condition affects the eyes and can lead to vision loss. The trial is comparing the effectiveness of EYP-1901 with a standard treatment called Aflibercept. It will last for two years, but the main results will be looked at after one year.
To participate in this study, you need to be at least 18 years old and have a diagnosed case of wAMD in one of your eyes. Your vision should be at a certain level, meaning you can see well enough to read letters on an eye chart, but not too poorly. If you've already received treatments for wAMD, you need to have had at least two injections in the last six months. Participants will receive either EYP-1901 or Aflibercept and will be monitored regularly to see how their vision changes over time. If you're interested in joining, it's important to note that certain eye conditions could exclude you from the study.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Previously treated or treatment naïve patients with a documented diagnosis of wAMD in the study eye, with onset of disease that began at any time prior to the Screening Visit.
- • Best Corrected Visual Acuity (BCVA) by Early Treatment Diabetic Retinopathy Study (ETDRS) letter score between 78 to 35 letters (approximately 20/32 to 20/200 Snellen equivalent) in the study eye at the Screening Visit and on Baseline (Day 1).
- • For previously-treated subjects, must have been treated with at least 2 anti-VEGF IVT injections (i.e., aflibercept 2 mg, aflibercept 8 mg, bevacizumab, ranibizumab, or faricimab) in the previous 6 months for wAMD per standard of care in the study eye prior to the Screening Visit.
- Exclusion Criteria:
- • Subfoveal fibrosis, atrophy, or scarring in the center subfield.
- • BCVA using ETDRS charts \<20 letters (20/400 Snellen equivalent) in the fellow eye.
About Eyepoint Pharmaceuticals, Inc.
Eyepoint Pharmaceuticals, Inc. is a dedicated biopharmaceutical company focused on the development and commercialization of innovative sustained-release therapies for serious eye diseases. With a strong emphasis on advancing ocular drug delivery technologies, Eyepoint aims to improve patient outcomes through its proprietary platform that enhances the efficacy and safety of therapeutic agents. The company is committed to addressing unmet medical needs in ophthalmology, leveraging its expertise to bring forward solutions that provide long-lasting benefits for patients with chronic conditions such as macular degeneration and diabetic retinopathy. Through rigorous clinical trials and a patient-centric approach, Eyepoint Pharmaceuticals strives to be at the forefront of transforming eye care.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
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Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported