Clinical Trials in the USA / NCT06668064
Active, not recruiting
Phase 3
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
NCT06668064 · tracked via the Priya Life Science USA tracker
Condition(s) studied
Wet Age Related Macular DegenerationwAMD
Investigational drug(s) / intervention(s)
EYP-1901: Intravitreal Injection
Aflibercept (2.0 mg): Intravitreal Injection
Study summary
This is a phase 3 randomized, double -masked study comparing the efficacy of EYP-1901 against Aflibercept.
Eligibility
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.
Primary outcome measure(s)
- Average change in best corrected visual acuity (BCVA) — Weeks 52 and 56
Trial sites (76)
| Facility | City | Region | Status |
|---|---|---|---|
| Retinal Research Institute, LLC | Phoenix | Arizona | |
| Retina Partners of Northwest Arkansas | Springdale | Arkansas | |
| California Retina Consultants | Bakersfield | California | |
| Retina Vitreous Associates Medical Group | Beverly Hills | California | |
| Macula and Retina Institute | Glendale | California | |
| Retina Consultants San Diego | Poway | California | |
| Retina Consultants of Southern California | Redlands | California | |
| Retinal Consultants Medical Group | Sacramento | California | |
| Bay Area Retina Associates | Walnut Creek | California | |
| American Institute of Research | Whittier | California | |
| RSC Research, PLLC | Denver | Colorado | |
| Eye Center of Northern Colorado, PC | Fort Collins | Colorado | |
| Advanced Vision Institute | Longmont | Colorado | |
| Connecticut Eye Consultants, P.C. | Danbury | Connecticut | |
| SightSera Clinical Research LLC | Greenwich | Connecticut | |
| Retina Group of New England, PC | Waterford | Connecticut | |
| Advanced Research, LLC | Deerfield Beach | Florida | |
| Florida Retina Consultants | Lakeland | Florida | |
| Florida Retina Institute | Orlando | Florida | |
| Retina Specialty Institute | Pensacola | Florida | |
| Eye Associates of Pinellas | Pinellas Park | Florida | |
| MedEye Associates | South Miami | Florida | |
| Retina Specialists of Tampa | Tampa | Florida | |
| Retina Vitreous Associates of Florida | Tampa | Florida | |
| Center for Retina & Macular Disease | Winter Haven | Florida | |
| Gerogia Retina | Marietta | Georgia | |
| Retina Consultants of Hawaii | ‘Aiea | Hawaii | |
| Retina Associates | Elmhurst | Illinois | |
| University Retina and Macula Associates | Lemont | Illinois | |
| Midwest Eye Institute | Carmel | Indiana | |
| Retina Associates LLC | Lenexa | Kansas | |
| Maine Eye Center | Portland | Maine | |
| The Retina Care Center | Baltimore | Maryland | |
| Retina Groups of Washington | Chevy Chase | Maryland | |
| Cumberland Valley Retina Consultants | Hagerstown | Maryland | |
| Retina Specialists | Towson | Maryland | |
| Ophthalmic Consultants of Boston OCB - Boston | Boston | Massachusetts | |
| New England Retina Consultants | Springfield | Massachusetts | |
| Retina Associates of Michigan | Grand Blanc | Michigan | |
| Foundation for Vision Research | Grand Rapids | Michigan |
+ 36 more sites — see the full list on the official registry below.
More EyePoint Pharmaceuticals, Inc. trials in the USA
Other trials for the same condition
A 2-year Study of EYP-1901 in Subjects With Wet Age Related Macular Degeneration (wAMD) (LUCIA) Primary Efficacy Will be Determined at Week 56
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Pivotal 1 Study of ABBV-RGX-314 (Also Known as RGX-314) Gene Therapy Administered Via Subretinal Delivery One Time in Participants With nAMD
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Pivotal 2 Study of RGX-314 Gene Therapy in Participants With nAMD
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06668064 on ClinicalTrials.gov ↗ ← All trials in the USA