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 a new treatment called EYP-1901 to see if it works better than an existing medication 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 | 72 sites (Gilbert, Arizona and 71 other locations) |
| Trial ID | NCT06683742 on ClinicalTrials.gov |
What this trial studies
This phase 3 interventional study is designed to compare the efficacy of EYP-1901 against Aflibercept in patients with wet age-related macular degeneration (wAMD). It involves a randomized, double-masked approach to ensure unbiased results, with primary efficacy assessed at week 56. Eligible participants include both previously treated and treatment-naïve patients with specific visual acuity criteria. The study aims to provide insights into the effectiveness of EYP-1901 as a potential treatment option.
Who should consider this trial
Good fit: Ideal candidates are patients with a documented diagnosis of wAMD and specific visual acuity scores.
Not a fit: Patients with significant eye damage, such as subfoveal fibrosis or severe visual impairment in the fellow eye, may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could improve vision outcomes for patients suffering from wet age-related macular degeneration.
How similar studies have performed: Other studies have shown success with similar approaches in treating wAMD, indicating a promising avenue for EYP-1901.
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
Gilbert, Arizona and 71 other locations
- Associated Retina Consultans — Gilbert, Arizona, United States (Recruiting)
- Associated Retina Consultants - Phoenix — Phoenix, Arizona, United States (Recruiting)
- Phoenix Retina Clinical Trials, LLC — Phoenix, Arizona, United States (Recruiting)
- Retina Macula Institute of Arizona — Scottsdale, Arizona, United States (Recruiting)
- Win Retina — Arcadia, California, United States (Recruiting)
- Doctor Retina, PC — Beverly Hills, California, United States (Recruiting)
- The Retina Partners — Encino, California, United States (Recruiting)
- RCOC Clinical Research Institute Inc. — Fullerton, California, United States (Recruiting)
- Global Research Management, Inc. — Glendale, California, United States (Recruiting)
- Atlantis Eyecare — Huntington Beach, California, United States (Recruiting)
- South Coast Retina Center — Long Beach, California, United States (Recruiting)
- Retinal Consultants Medical Group — Modesto, California, United States (Recruiting)
- Northern California Retina Vitreous Associates Medical Group INC. — Mountain View, California, United States (Recruiting)
- Kaiser Permanente — Oakland, California, United States (Recruiting)
- California Retina Consultants Oxnard Office — Oxnard, California, United States (Recruiting)
- California Eye Specialists Medical Group, Inc. — Redlands, California, United States (Recruiting)
- SCPMG/Kaiser Permanente Riverside Medical Center — Riverside, California, United States (Recruiting)
- VRMG Inc — Sacramento, California, United States (Recruiting)
- Macula Retina Vitreous Research Institute — Torrance, California, United States (Recruiting)
- Retina Consultants of Southern Colorado — Colorado Springs, Colorado, United States (Recruiting)
- Colorado Retina Associates — Lakewood, Colorado, United States (Recruiting)
- Blue Ocean Clinical Research — Clearwater, Florida, United States (Recruiting)
- Rand Eye Institute — Deerfield Beach, Florida, United States (Recruiting)
- Retina Group of Florida — Fort Lauderdale, Florida, United States (Recruiting)
- National Ophthalmic Research Institute — Fort Myers, Florida, United States (Recruiting)
- The Eye Institute of West Florida — Largo, Florida, United States (Recruiting)
- Retina Care Specialists — Palm Beach Gardens, Florida, United States (Recruiting)
- Fort Lauderdale Eye Institute — Plantation, Florida, United States (Recruiting)
- Retina Vitreous Associates of Florida - Saint Petersburg — St. Petersburg, Florida, United States (Recruiting)
- East Florida Eye Institute — Stuart, Florida, United States (Recruiting)
- Gailey Eye Clinic — Bloomington, Illinois, United States (Recruiting)
- Illinois Retina Associates, S.C. — Oak Park, Illinois, United States (Recruiting)
- Avruc — Carmel, Indiana, United States (Recruiting)
- Retina Associates of Kentucky — Lexington, Kentucky, United States (Recruiting)
- The Eye Care Institute — Louisville, Kentucky, United States (Recruiting)
- Retina Associates New Orleans — Metairie, Louisiana, United States (Recruiting)
- Haik Humble Eye Center — West Monroe, Louisiana, United States (Recruiting)
- Cumberland Valley Retina Consultants — Hagerstown, Maryland, United States (Recruiting)
- Mid Atlantic Retina Specialists — Hagerstown, Maryland, United States (Recruiting)
- Vitreo-Retinal Associates, PC — Worcester, Massachusetts, United States (Recruiting)
- Discover Vision Center — Independence, Missouri, United States (Recruiting)
- Envision Ocular, LLC — Bloomfield, New Jersey, United States (Recruiting)
- Mid Atlantic Retina — Cherry Hill, New Jersey, United States (Recruiting)
- NJ Retina — Edison, New Jersey, United States (Recruiting)
- NYC Retina — New York, New York, United States (Recruiting)
- VRCNY/Long Island Vitreoretinal Consultants — Westbury, New York, United States (Recruiting)
- Graystone Eye - Hickory Office — Hickory, North Carolina, United States (Recruiting)
- North Carolina Retina Associates — Wake Forest, North Carolina, United States (Recruiting)
- Retina Vitreous Center, PLLC — Edmond, Oklahoma, United States (Recruiting)
- Cascade Medical Research lnstitute, LLC — Springfield, Oregon, United States (Recruiting)
+22 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.