Clinical trial NCT06668064: 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
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: ACTIVE_NOT_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: 2024-10-31
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: Phoenix
country: United States
facility: Retinal Research Institute, LLC
state: Arizona
city: Springdale
country: United States
facility: Retina Partners of Northwest Arkansas
state: Arkansas
city: Bakersfield
country: United States
facility: California Retina Consultants
state: California
city: Beverly Hills
country: United States
facility: Retina Vitreous Associates Medical Group
state: California
city: Glendale
country: United States
facility: Macula and Retina Institute
state: California
city: Irvine
country: United States
facility: Gavin Herbert Eye Institute
state: California
city: Poway
country: United States
facility: Retina Consultants San Diego
state: California
city: Redlands
country: United States
facility: Retina Consultants of Southern California
state: California
city: Sacramento
country: United States
facility: Retinal Consultants Medical Group
state: California
city: San Francisco
country: United States
facility: West Coast Retina Medical Group
state: California
city: Walnut Creek
country: United States
facility: Bay Area Retina Associates
state: California
city: Whittier
country: United States
facility: American Institute of Research
state: California
city: Denver
country: United States
facility: RSC Research, PLLC
state: Colorado
city: Fort Collins
country: United States
facility: Eye Center of Northern Colorado, PC
state: Colorado
city: Longmont
country: United States
facility: Advanced Vision Institute
state: Colorado
city: Danbury
country: United States
facility: Connecticut Eye Consultants, P.C.
state: Connecticut
city: Greenwich
country: United States
facility: SightSera Clinical Research LLC
state: Connecticut
city: Waterford
country: United States
facility: Retina Group of New England, PC
state: Connecticut
city: Deerfield Beach
country: United States
facility: Advanced Research, LLC
state: Florida
city: Gainesville
country: United States
facility: Vitreo Retinal Associates
state: Florida
city: Lakeland
country: United States
facility: Florida Retina Consultants
state: Florida
city: Orlando
country: United States
facility: Florida Retina Institute
state: Florida
city: Pensacola
country: United States
facility: Retina Specialty Institute
state: Florida
city: Pinellas Park
country: United States
facility: Eye Associates of Pinellas
state: Florida
city: Sarasota
country: United States
facility: Retina Group of Florida
state: Florida
city: South Miami
country: United States
facility: MedEye Associates
state: Florida
city: Tampa
country: United States
facility: Retina Specialists of Tampa
state: Florida
city: Tampa
country: United States
facility: Retina Vitreous Associates of Florida
state: Florida
city: Winter Haven
country: United States
facility: Center for Retina & Macular Disease
state: Florida
city: Marietta
country: United States
facility: Gerogia Retina
state: Georgia
city: Aiea
country: United States
facility: Retina Consultants of Hawaii
state: Hawaii
city: Elmhurst
country: United States
facility: Retina Associates
state: Illinois
city: Lemont
country: United States
facility: University Retina and Macula Associates
state: Illinois
city: Carmel
country: United States
facility: Midwest Eye Institute
state: Indiana
city: Lenexa
country: United States
facility: Retina Associates LLC
state: Kansas
city: Portland
country: United States
facility: Maine Eye Center
state: Maine
city: Baltimore
country: United States
facility: The Retina Care Center
state: Maryland
city: Chevy Chase
country: United States
facility: Retina Groups of Washington
state: Maryland
city: Hagerstown
country: United States
facility: Cumberland Valley Retina Consultants
state: Maryland
city: Towson
country: United States
facility: Retina Specialists
state: Maryland
city: Boston
country: United States
facility: Ophthalmic Consultants of Boston OCB - Boston
state: Massachusetts
city: Springfield
country: United States
facility: New England Retina Consultants
state: Massachusetts
city: Grand Blanc
country: United States
facility: Retina Associates of Michigan
state: Michigan
city: Grand Rapids
country: United States
facility: Foundation for Vision Research
state: Michigan
city: Southaven
country: United States
facility: Deep Blue Retina Clinical Research PLLC
state: Mississippi
city: St Louis
country: United States
facility: The Retina Institute
state: Missouri
city: Reno
country: United States
facility: Sierra Eye Associates
state: Nevada
city: Teaneck
country: United States
facility: NJ Retina
state: New Jersey
city: Toms River
country: United States
facility: NJ Retina
state: New Jersey
city: Albuquerque
country: United States
facility: Vision Research Center at Eye Associates of New Mexico
state: New Mexico
city: Liverpool
country: United States
facility: Retina Vitreous Surgeons of CNY, PC
state: New York
city: Rochester
country: United States
facility: Retina Associates of Western NY, PC
state: New York
city: Slingerlands
country: United States
facility: Retina Consultants PLLC
state: New York
city: Asheville
country: United States
facility: Western Carolina Retinal Associates, PA
state: North Carolina
city: Wilmington
country: United States
facility: Cape Fear Retinal Associates, PC
state: North Carolina
city: Winston Salem
country: United States
facility: Piedmont Retina Specialists, P.A. - Winston-Salem Office
state: North Carolina
city: Dublin
country: United States
facility: Midwest Retina, Inc.
state: Ohio
city: Tulsa
country: United States
facility: Tulsa Retina Consultant
state: Oklahoma
city: Eugene
country: United States
facility: Verum Research LLC
state: Oregon
city: Erie
country: United States
facility: Erie Retina Research
state: Pennsylvania
city: Kingston
country: United States
facility: Eye Care Specialists - Kingston Location
state: Pennsylvania
city: Charleston
country: United States
facility: Retina Consultants
state: South Carolina
city: Florence
country: United States
facility: Palmetto Retina Center
state: South Carolina
city: Greenville
country: United States
facility: Retina Consultants of Carolina P.A
state: South Carolina
city: Germantown
country: United States
facility: Charles Retina Institute
state: Tennessee
city: Abilene
country: United States
facility: Retina Research Institute of Texas Integrated Clinical Research
state: Texas
city: Bellaire
country: United States
facility: Retina and Vitreous of Texas
state: Texas
city: Bellaire
country: United States
facility: Retina Consultants of Texas (Retina Consultants of Houston) - Woodlands
state: Texas
city: Dallas
country: United States
facility: Texas Retina Associates
state: Texas
city: Houston
country: United States
facility: Houston Eye Associates
state: Texas
city: Houston
country: United States
facility: Baylor College of Medicine Alkek Eye Center
state: Texas
city: Plano
country: United States
facility: Texas Retina Associates
state: Texas
city: San Antonio
country: United States
facility: San Antonio Eye Center
state: Texas
city: San Antonio
country: United States
facility: Retinal Consultants of Texas
state: Texas
city: Southlake
country: United States
facility: Retina Center of Texas
state: Texas
city: The Woodlands
country: United States
facility: Retina Consultants of Texas
state: Texas
city: Tyler
country: United States
facility: Tyler Retina Consultants
state: Texas
city: Willow Park
country: United States
facility: Strategic Clinical Research Group, LLC
state: Texas
city: Salt Lake City
country: United States
facility: Retina Associates of Utah
state: Utah
city: Salt Lake City
country: United States
facility: Rocky Mountain Retina Consultants
state: Utah
city: West Jordan
country: United States
facility: Salt Lake Retina
state: Utah
city: Fairfax
country: United States
facility: The Retina Group of Washington
state: Virginia
city: Lynchburg
country: United States
facility: Piedmont Eye Center
state: Virginia
city: Winchester
country: United States
facility: Retina Associates, P.C.
state: Virginia
city: Madison
country: United States
facility: University of Wisconsin School of Medicine and Public Health (UWSMPH)
state: Wisconsin
Study officials:
References: