Evaluating EYP-1901 for treating wet age-related macular degeneration
A 2-year Phase 3, Multicenter, Prospective, Randomized, Double-Masked, Parallel-Group Study of EYP-1901, a Tyrosine Kinase Inhibitor (TKI), Compared to Aflibercept in Subjects With Wet AMD
This study is testing if a new treatment called EYP-1901 can work better than the standard drug Aflibercept for people with wet age-related macular degeneration.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 400 (estimated) |
| Ages | 50 Years and up |
| Sex | All |
| Sponsor | EyePoint Pharmaceuticals, Inc. Industry-sponsored |
| Drugs / interventions | bevacizumab, ranibizumab, faricimab |
| Locations | 81 sites (Phoenix, Arizona and 80 other locations) |
| Trial ID | NCT06668064 on ClinicalTrials.gov |
What this trial studies
This phase 3 interventional study is designed to compare the efficacy of EYP-1901, a tyrosine kinase inhibitor, against Aflibercept in patients with wet age-related macular degeneration (wAMD). The study will involve a randomized, double-masked approach to ensure unbiased results, with primary efficacy assessed at week 56. Participants will include both previously treated and treatment-naïve patients who meet specific visual acuity criteria. The goal is to determine if EYP-1901 can provide better outcomes than the current standard treatment.
Who should consider this trial
Good fit: Ideal candidates are patients with a documented diagnosis of wAMD and a specific range of visual acuity scores.
Not a fit: Patients with severe vision loss or certain types of eye damage, such as subfoveal fibrosis or scarring, may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could offer improved vision outcomes for patients suffering from wet age-related macular degeneration.
How similar studies have performed: Previous studies have shown promise with similar approaches, but the specific efficacy of EYP-1901 remains to be fully established.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Phoenix, Arizona and 80 other locations
- Retinal Research Institute, LLC — Phoenix, Arizona, United States (Recruiting)
- Retina Partners of Northwest Arkansas — Springdale, Arkansas, United States (Recruiting)
- California Retina Consultants — Bakersfield, California, United States (Recruiting)
- Retina Vitreous Associates Medical Group — Beverly Hills, California, United States (Recruiting)
- Macula and Retina Institute — Glendale, California, United States (Recruiting)
- Retina Consultants San Diego — Poway, California, United States (Recruiting)
- Retina Consultants of Southern California — Redlands, California, United States (Recruiting)
- Retinal Consultants Medical Group — Sacramento, California, United States (Recruiting)
- Bay Area Retina Associates — Walnut Creek, California, United States (Recruiting)
- American Institute of Research — Whittier, California, United States (Recruiting)
- RSC Research, PLLC — Denver, Colorado, United States (Recruiting)
- Eye Center of Northern Colorado, PC — Fort Collins, Colorado, United States (Recruiting)
- Advanced Vision Institute — Longmont, Colorado, United States (Recruiting)
- Connecticut Eye Consultants, P.C. — Danbury, Connecticut, United States (Recruiting)
- SightSera Clinical Research LLC — Greenwich, Connecticut, United States (Recruiting)
- Retina Group of New England, PC — Waterford, Connecticut, United States (Recruiting)
- Advanced Research, LLC — Deerfield Beach, Florida, United States (Recruiting)
- Vitreo Retinal Associates — Gainesville, Florida, United States (Recruiting)
- Florida Retina Consultants — Lakeland, Florida, United States (Recruiting)
- Florida Retina Institute — Orlando, Florida, United States (Recruiting)
- Retina Specialty Institute — Pensacola, Florida, United States (Recruiting)
- Eye Associates of Pinellas — Pinellas Park, Florida, United States (Recruiting)
- Retina Group of Florida — Sarasota, Florida, United States (Recruiting)
- MedEye Associates — South Miami, Florida, United States (Recruiting)
- Retina Specialists of Tampa — Tampa, Florida, United States (Recruiting)
- Retina Vitreous Associates of Florida — Tampa, Florida, United States (Recruiting)
- Center for Retina & Macular Disease — Winter Haven, Florida, United States (Recruiting)
- Gerogia Retina — Marietta, Georgia, United States (Recruiting)
- Retina Consultants of Hawaii — Aiea, Hawaii, United States (Recruiting)
- Retina Associates — Elmhurst, Illinois, United States (Recruiting)
- University Retina and Macula Associates — Lemont, Illinois, United States (Recruiting)
- Midwest Eye Institute — Carmel, Indiana, United States (Recruiting)
- Retina Associates LLC — Lenexa, Kansas, United States (Recruiting)
- Maine Eye Center — Portland, Maine, United States (Recruiting)
- The Retina Care Center — Baltimore, Maryland, United States (Recruiting)
- Retina Groups of Washington — Chevy Chase, Maryland, United States (Recruiting)
- Cumberland Valley Retina Consultants — Hagerstown, Maryland, United States (Recruiting)
- Retina Specialists — Towson, Maryland, United States (Recruiting)
- Ophthalmic Consultants of Boston OCB - Boston — Boston, Massachusetts, United States (Recruiting)
- New England Retina Consultants — Springfield, Massachusetts, United States (Recruiting)
- Retina Associates of Michigan — Grand Blanc, Michigan, United States (Recruiting)
- Foundation for Vision Research — Grand Rapids, Michigan, United States (Recruiting)
- Deep Blue Retina Clinical Research PLLC — Southaven, Mississippi, United States (Recruiting)
- The Retina Institute — St Louis, Missouri, United States (Recruiting)
- Sierra Eye Associates — Reno, Nevada, United States (Recruiting)
- NJ Retina — Teaneck, New Jersey, United States (Recruiting)
- NJ Retina — Toms River, New Jersey, United States (Recruiting)
- Vision Research Center at Eye Associates of New Mexico — Albuquerque, New Mexico, United States (Recruiting)
- Retina Vitreous Surgeons of CNY, PC — Liverpool, New York, United States (Recruiting)
- Retina Associates of Western NY, PC — Rochester, New York, United States (Recruiting)
+31 more sites — see ClinicalTrials.gov for the full list.
Study contacts
- Study coordinator: Ramiro Ribeiro, MD, PhD
- Email: rriberio@eyepointpharma.com
- Phone: 833-393-7646
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.