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
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
Retinal Research Institute, LLC
Phoenix, Arizona 85053
Phoenix, Arizona 85053
Retina Partners of Northwest Arkansas
Springdale, Arkansas 72764
Springdale, Arkansas 72764
California Retina Consultants
Bakersfield, California 93309
Bakersfield, California 93309
Retina Vitreous Associates Medical Group
Beverly Hills, California 90211
Beverly Hills, California 90211
Macula and Retina Institute
Glendale, California 91203
Glendale, California 91203
Retina Consultants San Diego
Poway, California 92064
Poway, California 92064
Retina Consultants of Southern California
Redlands, California 92374
Redlands, California 92374
Retinal Consultants Medical Group
Sacramento, California 95841
Sacramento, California 95841
Bay Area Retina Associates
Walnut Creek, California 94598
Walnut Creek, California 94598
American Institute of Research
Whittier, California 95008
Whittier, California 95008
RSC Research, PLLC
Denver, Colorado 80210
Denver, Colorado 80210
Eye Center of Northern Colorado, PC
Fort Collins, Colorado 80528
Fort Collins, Colorado 80528
Advanced Vision Institute
Longmont, Colorado 80503
Longmont, Colorado 80503
Connecticut Eye Consultants, P.C.
Danbury, Connecticut 06810
Danbury, Connecticut 06810
SightSera Clinical Research LLC
Greenwich, Connecticut 06830
Greenwich, Connecticut 06830
Retina Group of New England, PC
Waterford, Connecticut 06385
Waterford, Connecticut 06385
Advanced Research, LLC
Deerfield Beach, Florida 33064
Deerfield Beach, Florida 33064
Vitreo Retinal Associates
Gainesville, Florida 32607
Gainesville, Florida 32607
Florida Retina Consultants
Lakeland, Florida 33805
Lakeland, Florida 33805
Florida Retina Institute
Orlando, Florida 32806
Orlando, Florida 32806
Retina Specialty Institute
Pensacola, Florida 32503
Pensacola, Florida 32503
Eye Associates of Pinellas
Pinellas Park, Florida 33782
Pinellas Park, Florida 33782
Retina Group of Florida
Sarasota, Florida 34232
Sarasota, Florida 34232
MedEye Associates
South Miami, Florida 33143
South Miami, Florida 33143
Retina Specialists of Tampa
Tampa, Florida 33544
Tampa, Florida 33544
Retina Vitreous Associates of Florida
Tampa, Florida 33617
Tampa, Florida 33617
Center for Retina & Macular Disease
Winter Haven, Florida 33880
Winter Haven, Florida 33880
Gerogia Retina
Marietta, Georgia 30060
Marietta, Georgia 30060
Retina Consultants of Hawaii
Aiea, Hawaii 96701
Aiea, Hawaii 96701
Retina Associates
Elmhurst, Illinois 60126
Elmhurst, Illinois 60126
University Retina and Macula Associates
Lemont, Illinois 60439
Lemont, Illinois 60439
Midwest Eye Institute
Carmel, Indiana 46290
Carmel, Indiana 46290
Retina Associates LLC
Lenexa, Kansas 66215
Lenexa, Kansas 66215
Maine Eye Center
Portland, Maine 04101
Portland, Maine 04101
The Retina Care Center
Baltimore, Maryland 21209
Baltimore, Maryland 21209
Retina Groups of Washington
Chevy Chase, Maryland 20815
Chevy Chase, Maryland 20815
Cumberland Valley Retina Consultants
Hagerstown, Maryland 21740
Hagerstown, Maryland 21740
Retina Specialists
Towson, Maryland 21204
Towson, Maryland 21204
Ophthalmic Consultants of Boston OCB - Boston
Boston, Massachusetts 02114
Boston, Massachusetts 02114
New England Retina Consultants
Springfield, Massachusetts 01107
Springfield, Massachusetts 01107
Retina Associates of Michigan
Grand Blanc, Michigan 48439
Grand Blanc, Michigan 48439
Foundation for Vision Research
Grand Rapids, Michigan 49546
Grand Rapids, Michigan 49546
Deep Blue Retina Clinical Research PLLC
Southaven, Mississippi 38671
Southaven, Mississippi 38671
The Retina Institute
St Louis, Missouri 63128
St Louis, Missouri 63128
Sierra Eye Associates
Reno, Nevada 89502
Reno, Nevada 89502
NJ Retina
Teaneck, New Jersey 07666
Teaneck, New Jersey 07666
NJ Retina
Toms River, New Jersey 08755
Toms River, New Jersey 08755
Vision Research Center at Eye Associates of New Mexico
Albuquerque, New Mexico 87109
Albuquerque, New Mexico 87109
Retina Vitreous Surgeons of CNY, PC
Liverpool, New York 13088
Liverpool, New York 13088
Retina Associates of Western NY, PC
Rochester, New York 14620
Rochester, New York 14620
Retina Consultants PLLC
Slingerlands, New York 12159
Slingerlands, New York 12159
Western Carolina Retinal Associates, PA
Asheville, North Carolina 28803
Asheville, North Carolina 28803
Cape Fear Retinal Associates, PC
Wilmington, North Carolina 28401
Wilmington, North Carolina 28401
Piedmont Retina Specialists, P.A. - Winston-Salem Office
Winston Salem, North Carolina 27103
Winston Salem, North Carolina 27103
Tulsa Retina Consultant
Tulsa, Oklahoma 74114
Tulsa, Oklahoma 74114
Verum Research LLC
Eugene, Oregon 97401
Eugene, Oregon 97401
Erie Retina Research
Erie, Pennsylvania 16507
Erie, Pennsylvania 16507
Eye Care Specialists - Kingston Location
Kingston, Pennsylvania 18704
Kingston, Pennsylvania 18704
Retina Consultants
Charleston, South Carolina 29414
Charleston, South Carolina 29414
Palmetto Retina Center
Florence, South Carolina 29169
Florence, South Carolina 29169
Retina Consultants of Carolina P.A
Greenville, South Carolina 29605
Greenville, South Carolina 29605
Charles Retina Institute
Germantown, Tennessee 38138
Germantown, Tennessee 38138
Retina Research Institute of Texas Integrated Clinical Research
Abilene, Texas 79606
Abilene, Texas 79606
Retina and Vitreous of Texas
Bellaire, Texas 77401
Bellaire, Texas 77401
Retina Consultants of Texas (Retina Consultants of Houston) - Woodlands
Bellaire, Texas 77401
Bellaire, Texas 77401
Texas Retina Associates
Dallas, Texas 75231
Dallas, Texas 75231
Houston Eye Associates
Houston, Texas 77025
Houston, Texas 77025
Texas Retina Associates
Plano, Texas 75075
Plano, Texas 75075
San Antonio Eye Center
San Antonio, Texas 78215
San Antonio, Texas 78215
Retinal Consultants of Texas
San Antonio, Texas 78240
San Antonio, Texas 78240
Retina Center of Texas
Southlake, Texas 76092
Southlake, Texas 76092
Retina Consultants of Texas
The Woodlands, Texas 77384
The Woodlands, Texas 77384
Tyler Retina Consultants
Tyler, Texas 75703
Tyler, Texas 75703
Strategic Clinical Research Group, LLC
Willow Park, Texas 76087
Willow Park, Texas 76087
Retina Associates of Utah
Salt Lake City, Utah 84107
Salt Lake City, Utah 84107
Rocky Mountain Retina Consultants
Salt Lake City, Utah 84107
Salt Lake City, Utah 84107
Salt Lake Retina
West Jordan, Utah 84088
West Jordan, Utah 84088
The Retina Group of Washington
Fairfax, Virginia 22031
Fairfax, Virginia 22031
Piedmont Eye Center
Lynchburg, Virginia 24502
Lynchburg, Virginia 24502
Retina Associates, P.C.
Winchester, Virginia 22601
Winchester, Virginia 22601
University of Wisconsin School of Medicine and Public Health (UWSMPH)
Madison, Wisconsin 53705
Madison, Wisconsin 53705
More Details
- NCT ID
- NCT06668064
- Status
- Recruiting
- Sponsor
- EyePoint Pharmaceuticals, Inc.