Clinical trial NCT06683742: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Wet Age Related Macular Degeneration
wAMD
Keywords: Wet Age-related Macular Degeneration
Tyrosine Kinase Inhibitor
EYP-1901
EyePoint
Lead sponsor: EyePoint Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2024-11-12
Enrollment: 400
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a phase 3 randomized, double -masked study comparing the efficacy of EYP-1901 against Aflibercept.


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.

Primary outcomes:
measure: Average change in best corrected visual acuity (BCVA)
timeFrame: Weeks 52 and 56
Secondary outcomes:
measure: Rate of injection burden
timeFrame: Week 56
measure: Average change in best corrected visual acuity (BCVA)
timeFrame: Week 96
Other outcomes:
Locations:
city: Gilbert
country: United States
facility: Associated Retina Consultans
state: Arizona
city: Phoenix
country: United States
facility: Associated Retina Consultants - Phoenix
state: Arizona
city: Phoenix
country: United States
facility: Phoenix Retina Clinical Trials, LLC
state: Arizona
city: Scottsdale
country: United States
facility: Retina Macula Institute of Arizona
state: Arizona
city: Arcadia
country: United States
facility: Win Retina
state: California
city: Beverly Hills
country: United States
facility: Doctor Retina, PC
state: California
city: Encino
country: United States
facility: The Retina Partners
state: California
city: Fullerton
country: United States
facility: RCOC Clinical Research Institute Inc.
state: California
city: Glendale
country: United States
facility: Global Research Management, Inc.
state: California
city: Huntington Beach
country: United States
facility: Atlantis Eyecare
state: California
city: Long Beach
country: United States
facility: South Coast Retina Center
state: California
city: Modesto
country: United States
facility: Retinal Consultants Medical Group
state: California
city: Mountain View
country: United States
facility: Northern California Retina Vitreous Associates Medical Group INC.
state: California
city: Oakland
country: United States
facility: Kaiser Permanente
state: California
city: Oxnard
country: United States
facility: California Retina Consultants Oxnard Office
state: California
city: Redlands
country: United States
facility: California Eye Specialists Medical Group, Inc.
state: California
city: Riverside
country: United States
facility: SCPMG/Kaiser Permanente Riverside Medical Center
state: California
city: Sacramento
country: United States
facility: VRMG Inc
state: California
city: Torrance
country: United States
facility: Macula Retina Vitreous Research Institute
state: California
city: Colorado Springs
country: United States
facility: Retina Consultants of Southern Colorado
state: Colorado
city: Lakewood
country: United States
facility: Colorado Retina Associates
state: Colorado
city: Clearwater
country: United States
facility: Blue Ocean Clinical Research
state: Florida
city: Deerfield Beach
country: United States
facility: Rand Eye Institute
state: Florida
city: Fort Lauderdale
country: United States
facility: Retina Group of Florida
state: Florida
city: Fort Myers
country: United States
facility: National Ophthalmic Research Institute
state: Florida
city: Largo
country: United States
facility: The Eye Institute of West Florida
state: Florida
city: Palm Beach Gardens
country: United States
facility: Retina Care Specialists
state: Florida
city: Plantation
country: United States
facility: Fort Lauderdale Eye Institute
state: Florida
city: St. Petersburg
country: United States
facility: Retina Vitreous Associates of Florida - Saint Petersburg
state: Florida
city: Stuart
country: United States
facility: East Florida Eye Institute
state: Florida
city: Bloomington
country: United States
facility: Gailey Eye Clinic
state: Illinois
city: Oak Park
country: United States
facility: Illinois Retina Associates, S.C.
state: Illinois
city: Plainfield
country: United States
facility: Red River Research Partners
state: Illinois
city: Carmel
country: United States
facility: AVRUC
state: Indiana
city: Lexington
country: United States
facility: Retina Associates of Kentucky
state: Kentucky
city: Louisville
country: United States
facility: The Eye Care Institute
state: Kentucky
city: Metairie
country: United States
facility: Retina Associates New Orleans
state: Louisiana
city: West Monroe
country: United States
facility: Haik Humble Eye Center
state: Louisiana
city: Hagerstown
country: United States
facility: Cumberland Valley Retina Consultants
state: Maryland
city: Hagerstown
country: United States
facility: Mid Atlantic Retina Specialists
state: Maryland
city: Worcester
country: United States
facility: Vitreo-Retinal Associates, PC
state: Massachusetts
city: Independence
country: United States
facility: Discover Vision Center
state: Missouri
city: Bloomfield
country: United States
facility: Envision Ocular, LLC
state: New Jersey
city: Cherry Hill
country: United States
facility: Mid Atlantic Retina
state: New Jersey
city: Edison
country: United States
facility: NJ Retina
state: New Jersey
city: New York
country: United States
facility: NYC Retina
state: New York
city: Westbury
country: United States
facility: VRCNY/Long Island Vitreoretinal Consultants
state: New York
city: Cary
country: United States
facility: NC Retina Associates - Cary Research
state: North Carolina
city: Hickory
country: United States
facility: Graystone Eye - Hickory Office
state: North Carolina
city: Wake Forest
country: United States
facility: North Carolina Retina Associates
state: North Carolina
city: Edmond
country: United States
facility: Retina Vitreous Center, PLLC
state: Oklahoma
city: Portland
country: United States
facility: Casey Eye Institute at OHSU
state: Oregon
city: Springfield
country: United States
facility: Cascade Medical Research lnstitute, LLC
state: Oregon
city: Bethlehem
country: United States
facility: Wills Eye Physician Mid Atlantic Retina
state: Pennsylvania
city: Monroeville
country: United States
facility: Retina Vitreous Consultants (RVC) - Monroeville
state: Pennsylvania
city: Ladson
country: United States
facility: Charleston Neuroscience Institute
state: South Carolina
city: Rapid City
country: United States
facility: Black Hills Regional Eye Institute
state: South Dakota
city: Nashville
country: United States
facility: Tennessee Retina
state: Tennessee
city: Amarillo
country: United States
facility: Panhandle Eye Group, LLP. - Southwest Retina Specialists
state: Texas
city: Arlington
country: United States
facility: Texas Retina Associates
state: Texas
city: Austin
country: United States
facility: Austin Research Center for Retina
state: Texas
city: Austin
country: United States
facility: Austin Retina Associates
state: Texas
city: Austin
country: United States
facility: Austin Clinical Research LLC
state: Texas
city: Beaumont
country: United States
facility: TX RCTX Retina Consultants of Texas
state: Texas
city: Burleson
country: United States
facility: Star Vision Research
state: Texas
city: Dallas
country: United States
facility: Retina of North Texas
state: Texas
city: Houston
country: United States
facility: Berkeley Eye Center
state: Texas
city: Katy
country: United States
facility: Retina Consultants of Texas
state: Texas
city: Mcallen
country: United States
facility: Valley Retina Institute P.A.
state: Texas
city: Plano
country: United States
facility: Red River Research Partners, LLC
state: Texas
city: San Antonio
country: United States
facility: TX RCTX Retina Consultants of Texas
state: Texas
city: San Antonio
country: United States
facility: Retina Associates of South Texas
state: Texas
city: Tyler
country: United States
facility: Tyler Retina Consultants
state: Texas
city: Falls Church
country: United States
facility: Emerson Clinical Research Institute
state: Virginia
city: Warrenton
country: United States
facility: Virginia Retina Center
state: Virginia
city: Bellevue
country: United States
facility: Pacific Northwest Retina
state: Washington
city: Albury
country: Australia
facility: Eye Clinic Albury Wodonga
city: East Melbourne
country: Australia
facility: Cerulea
city: Parramatta
country: Australia
facility: Marsden Eye Specialists
city: Sydney
country: Australia
facility: Sydney Retina Clinic and Day Surgery
city: Be'er Ya'akov
country: Israel
facility: Shamir Medical Center Ophthalmology Out Patient Clinic
city: Kfar Saba
country: Israel
facility: Meir Medical Center Ophthalmology Department
city: Petah Tikva
country: Israel
facility: Rabin Medical Center
city: Rehovot
country: Israel
facility: Kaplan Medical Center
Study officials:
References: