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
Purpose
This is a phase 3 randomized, double -masked study comparing the efficacy of EYP-1901 against Aflibercept.
Conditions
- Wet Age Related Macular Degeneration
- wAMD
Eligibility
- Eligible Ages
- Over 50 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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.
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental EYP-1901 2686 µg |
EYP-1901 |
|
|
Active Comparator Aflibercept |
|
Recruiting Locations
Associated Retina Consultans
Gilbert, Arizona 85297
Gilbert, Arizona 85297
Associated Retina Consultants - Phoenix
Phoenix, Arizona 85020
Phoenix, Arizona 85020
Phoenix Retina Clinical Trials, LLC
Phoenix, Arizona 85050
Phoenix, Arizona 85050
Retina Macula Institute of Arizona
Scottsdale, Arizona 85255
Scottsdale, Arizona 85255
Win Retina
Arcadia, California 91006
Arcadia, California 91006
Doctor Retina, PC
Beverly Hills, California 90211
Beverly Hills, California 90211
The Retina Partners
Encino, California 91436
Encino, California 91436
RCOC Clinical Research Institute Inc.
Fullerton, California 92835
Fullerton, California 92835
Global Research Management, Inc.
Glendale, California 91204
Glendale, California 91204
Atlantis Eyecare
Huntington Beach, California 92647
Huntington Beach, California 92647
South Coast Retina Center
Long Beach, California 90807
Long Beach, California 90807
Retinal Consultants Medical Group
Modesto, California 95356
Modesto, California 95356
Northern California Retina Vitreous Associates Medical Group INC.
Mountain View, California 94040
Mountain View, California 94040
Kaiser Permanente
Oakland, California 94611
Oakland, California 94611
California Retina Consultants Oxnard Office
Oxnard, California 93036
Oxnard, California 93036
California Eye Specialists Medical Group, Inc.
Redlands, California 92373
Redlands, California 92373
SCPMG/Kaiser Permanente Riverside Medical Center
Riverside, California 45580
Riverside, California 45580
VRMG Inc
Sacramento, California 95825
Sacramento, California 95825
Macula Retina Vitreous Research Institute
Torrance, California 90503
Torrance, California 90503
Retina Consultants of Southern Colorado
Colorado Springs, Colorado 80909
Colorado Springs, Colorado 80909
Colorado Retina Associates
Lakewood, Colorado 80228
Lakewood, Colorado 80228
Blue Ocean Clinical Research
Clearwater, Florida 33761
Clearwater, Florida 33761
Rand Eye Institute
Deerfield Beach, Florida 33064
Deerfield Beach, Florida 33064
Retina Group of Florida
Fort Lauderdale, Florida 33308
Fort Lauderdale, Florida 33308
National Ophthalmic Research Institute
Fort Myers, Florida 33912
Fort Myers, Florida 33912
The Eye Institute of West Florida
Largo, Florida 33770
Largo, Florida 33770
Retina Care Specialists
Palm Beach Gardens, Florida 45674
Palm Beach Gardens, Florida 45674
Fort Lauderdale Eye Institute
Plantation, Florida 33324
Plantation, Florida 33324
Retina Vitreous Associates of Florida - Saint Petersburg
St. Petersburg, Florida 33711
St. Petersburg, Florida 33711
East Florida Eye Institute
Stuart, Florida 34994
Stuart, Florida 34994
Gailey Eye Clinic
Bloomington, Illinois 60616
Bloomington, Illinois 60616
Illinois Retina Associates, S.C.
Oak Park, Illinois 60304
Oak Park, Illinois 60304
Red River Research Partners
Plainfield, Illinois 60586
Plainfield, Illinois 60586
AVRUC
Carmel, Indiana 46032
Carmel, Indiana 46032
Retina Associates of Kentucky
Lexington, Kentucky 40509
Lexington, Kentucky 40509
The Eye Care Institute
Louisville, Kentucky 40206
Louisville, Kentucky 40206
Retina Associates New Orleans
Metairie, Louisiana 70006
Metairie, Louisiana 70006
Haik Humble Eye Center
West Monroe, Louisiana 71291
West Monroe, Louisiana 71291
Cumberland Valley Retina Consultants
Hagerstown, Maryland 21740
Hagerstown, Maryland 21740
Mid Atlantic Retina Specialists
Hagerstown, Maryland 21740
Hagerstown, Maryland 21740
Vitreo-Retinal Associates, PC
Worcester, Massachusetts 01605
Worcester, Massachusetts 01605
Discover Vision Center
Independence, Missouri 64081
Independence, Missouri 64081
Envision Ocular, LLC
Bloomfield, New Jersey 07003
Bloomfield, New Jersey 07003
Mid Atlantic Retina
Cherry Hill, New Jersey 08034
Cherry Hill, New Jersey 08034
NJ Retina
Edison, New Jersey 08820
Edison, New Jersey 08820
NYC Retina
New York, New York 45604
New York, New York 45604
VRCNY/Long Island Vitreoretinal Consultants
Westbury, New York 11590
Westbury, New York 11590
NC Retina Associates - Cary Research
Cary, North Carolina 27511
Cary, North Carolina 27511
Graystone Eye - Hickory Office
Hickory, North Carolina 28602
Hickory, North Carolina 28602
North Carolina Retina Associates
Wake Forest, North Carolina 27587
Wake Forest, North Carolina 27587
Retina Vitreous Center, PLLC
Edmond, Oklahoma 73013
Edmond, Oklahoma 73013
Casey Eye Institute at OHSU
Portland, Oregon 97239
Portland, Oregon 97239
Cascade Medical Research lnstitute, LLC
Springfield, Oregon 97477
Springfield, Oregon 97477
Wills Eye Physician Mid Atlantic Retina
Bethlehem, Pennsylvania 18017
Bethlehem, Pennsylvania 18017
Retina Vitreous Consultants (RVC) - Monroeville
Monroeville, Pennsylvania 45674
Monroeville, Pennsylvania 45674
Charleston Neuroscience Institute
Ladson, South Carolina 29456
Ladson, South Carolina 29456
Black Hills Regional Eye Institute
Rapid City, South Dakota 45526
Rapid City, South Dakota 45526
Tennessee Retina
Nashville, Tennessee 37203
Nashville, Tennessee 37203
Panhandle Eye Group, LLP. - Southwest Retina Specialists
Amarillo, Texas 79106
Amarillo, Texas 79106
Texas Retina Associates
Arlington, Texas 76012
Arlington, Texas 76012
Austin Research Center for Retina
Austin, Texas 45674
Austin, Texas 45674
Austin Retina Associates
Austin, Texas 78705
Austin, Texas 78705
Austin Clinical Research LLC
Austin, Texas 78750
Austin, Texas 78750
TX RCTX Retina Consultants of Texas
Beaumont, Texas 77707
Beaumont, Texas 77707
Star Vision Research
Burleson, Texas 76028
Burleson, Texas 76028
Retina of North Texas
Dallas, Texas 75243
Dallas, Texas 75243
Berkeley Eye Center
Houston, Texas 77027
Houston, Texas 77027
Retina Consultants of Texas
Katy, Texas 77494
Katy, Texas 77494
Valley Retina Institute P.A.
Mcallen, Texas 78503
Mcallen, Texas 78503
Red River Research Partners, LLC
Plano, Texas 75024
Plano, Texas 75024
TX RCTX Retina Consultants of Texas
San Antonio, Texas 78154
San Antonio, Texas 78154
Retina Associates of South Texas
San Antonio, Texas 78240
San Antonio, Texas 78240
Tyler Retina Consultants
Tyler, Texas 75703
Tyler, Texas 75703
Emerson Clinical Research Institute
Falls Church, Virginia 22046
Falls Church, Virginia 22046
Virginia Retina Center
Warrenton, Virginia 20186
Warrenton, Virginia 20186
Pacific Northwest Retina
Bellevue, Washington 98004
Bellevue, Washington 98004
More Details
- NCT ID
- NCT06683742
- Status
- Recruiting
- Sponsor
- EyePoint Pharmaceuticals, Inc.