ACTIVE_NOT_RECRUITING

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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Conditions

Wet Age Related Macular DegenerationwAMDWet Age-related Macular DegenerationTyrosine Kinase InhibitorEYP-1901EyePoint

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

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

Quick Facts

Study Start:2024-11-27
Study Completion:2027-10
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06683742

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:50 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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.
  2. * 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).
  3. * 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.
  1. * Subfoveal fibrosis, atrophy, or scarring in the center subfield.
  2. * BCVA using ETDRS charts \<20 letters (20/400 Snellen equivalent) in the fellow eye.

Contacts and Locations

Study Locations (Sites)

Associated Retina Consultans
Gilbert, Arizona, 85297
United States
Associated Retina Consultants - Phoenix
Phoenix, Arizona, 85020
United States
Phoenix Retina Clinical Trials, LLC
Phoenix, Arizona, 85050
United States
Retina Macula Institute of Arizona
Scottsdale, Arizona, 85255
United States
Win Retina
Arcadia, California, 91006
United States
Doctor Retina, PC
Beverly Hills, California, 90211
United States
The Retina Partners
Encino, California, 91436
United States
RCOC Clinical Research Institute Inc.
Fullerton, California, 92835
United States
Global Research Management, Inc.
Glendale, California, 91204
United States
Atlantis Eyecare
Huntington Beach, California, 92647
United States
South Coast Retina Center
Long Beach, California, 90807
United States
Retinal Consultants Medical Group
Modesto, California, 95356
United States
Northern California Retina Vitreous Associates Medical Group INC.
Mountain View, California, 94040
United States
Kaiser Permanente
Oakland, California, 94611
United States
California Retina Consultants Oxnard Office
Oxnard, California, 93036
United States
Retina Consultants San Diego
Poway, California, 92064
United States
California Eye Specialists Medical Group, Inc.
Redlands, California, 92373
United States
Retina Consultants of Southern California
Redlands, California, 92374
United States
SCPMG/Kaiser Permanente Riverside Medical Center
Riverside, California, 45580
United States
VRMG Inc
Sacramento, California, 95825
United States
Retinal Consultants Medical Group
Sacramento, California, 95841
United States
West Coast Retina Medical Group
San Francisco, California, 94109
United States
Macula Retina Vitreous Research Institute
Torrance, California, 90503
United States
Bay Area Retina Associates
Walnut Creek, California, 94598
United States
Retina Consultants of Southern Colorado
Colorado Springs, Colorado, 80909
United States
RSC Research, PLLC
Denver, Colorado, 80210
United States
Eye Center of Northern Colorado, PC
Fort Collins, Colorado, 80528
United States
Colorado Retina Associates
Lakewood, Colorado, 80228
United States
Connecticut Eye Consultants, P.C.
Danbury, Connecticut, 06810
United States
SightSera Clinical Research LLC
Greenwich, Connecticut, 06830
United States
Retina Group of New England, PC
Waterford, Connecticut, 06385
United States
Blue Ocean Clinical Research
Clearwater, Florida, 33761
United States
Advanced Research, LLC
Deerfield Beach, Florida, 33064
United States
Rand Eye Institute
Deerfield Beach, Florida, 33064
United States
Retina Group of Florida
Fort Lauderdale, Florida, 33308
United States
National Ophthalmic Research Institute
Fort Myers, Florida, 33912
United States
The Eye Institute of West Florida
Largo, Florida, 33770
United States
Retina Care Specialists
Palm Beach Gardens, Florida, 45674
United States
Fort Lauderdale Eye Institute
Plantation, Florida, 33324
United States
MedEye Associates
South Miami, Florida, 33143
United States
Retina Vitreous Associates of Florida - Saint Petersburg
St. Petersburg, Florida, 33711
United States
East Florida Eye Institute
Stuart, Florida, 34994
United States
Retina Specialists of Tampa
Tampa, Florida, 33618
United States
Georgia Retina
Marietta, Georgia, 30060
United States
Gailey Eye Clinic
Bloomington, Illinois, 60616
United States
Retina Associates
Elmhurst, Illinois, 60126
United States
Illinois Retina Associates, S.C.
Oak Park, Illinois, 60304
United States
Red River Research Partners
Plainfield, Illinois, 60586
United States
AVRUC
Carmel, Indiana, 46032
United States
Retina Associates of Kentucky
Lexington, Kentucky, 40509
United States
The Eye Care Institute
Louisville, Kentucky, 40206
United States
Retina Associates New Orleans
Metairie, Louisiana, 70006
United States
Haik Humble Eye Center
West Monroe, Louisiana, 71291
United States
The Retina Care Center
Baltimore, Maryland, 21209
United States
Retina Group of Washington
Chevy Chase, Maryland, 20815
United States
Cumberland Valley Retina Consultants
Hagerstown, Maryland, 21740
United States
Mid Atlantic Retina Specialists
Hagerstown, Maryland, 21740
United States
Vitreo-Retinal Associates, PC
Worcester, Massachusetts, 01605
United States
Retina Associates of Michigan
Grand Blanc, Michigan, 48439
United States
Discover Vision Center
Independence, Missouri, 64081
United States
Envision Ocular, LLC
Bloomfield, New Jersey, 07003
United States
Mid Atlantic Retina
Cherry Hill, New Jersey, 08034
United States
NJ Retina
Edison, New Jersey, 08820
United States
NJ Retina
Toms River, New Jersey, 08755
United States
Retina Vitreous Surgeons of CNY, PC
Liverpool, New York, 13088
United States
NYC Retina
New York, New York, 45604
United States
Retina Associates of Western NY, PC
Rochester, New York, 14620
United States
VRCNY/Long Island Vitreoretinal Consultants
Westbury, New York, 11590
United States
NC Retina Associates - Cary Research
Cary, North Carolina, 27511
United States
Graystone Eye - Hickory Office
Hickory, North Carolina, 28602
United States
North Carolina Retina Associates
Wake Forest, North Carolina, 27587
United States
Retina Vitreous Center, PLLC
Edmond, Oklahoma, 73013
United States
Tulsa Retina Consultants
Tulsa, Oklahoma, 74114
United States
Casey Eye Institute at OHSU
Portland, Oregon, 97239
United States
Cascade Medical Research lnstitute, LLC
Springfield, Oregon, 97477
United States
Wills Eye Physician Mid Atlantic Retina
Bethlehem, Pennsylvania, 18017
United States
Erie Retina Research
Erie, Pennsylvania, 16505
United States
Retina Vitreous Consultants (RVC) - Monroeville
Monroeville, Pennsylvania, 45674
United States
Charleston Neuroscience Institute
Ladson, South Carolina, 29456
United States
Black Hills Regional Eye Institute
Rapid City, South Dakota, 45526
United States
Tennessee Retina
Nashville, Tennessee, 37203
United States
Retina Research Institute of Texas Integrated Clinical Research
Abilene, Texas, 79606
United States
Panhandle Eye Group, LLP. - Southwest Retina Specialists
Amarillo, Texas, 79106
United States
Texas Retina Associates
Arlington, Texas, 76012
United States
Austin Research Center for Retina
Austin, Texas, 45674
United States
Austin Retina Associates
Austin, Texas, 78705
United States
Austin Clinical Research LLC
Austin, Texas, 78750
United States
TX RCTX Retina Consultants of Texas
Beaumont, Texas, 77707
United States
Star Vision Research
Burleson, Texas, 76028
United States
Texas Retina Associates
Dallas, Texas, 75231
United States
Retina of North Texas
Dallas, Texas, 75243
United States
Berkeley Eye Center
Houston, Texas, 77027
United States
Retina Consultants of Texas
Katy, Texas, 77494
United States
Valley Retina Institute P.A.
McAllen, Texas, 78503
United States
Red River Research Partners, LLC
Plano, Texas, 75024
United States
Texas Retina Associates
Plano, Texas, 75075
United States
TX RCTX Retina Consultants of Texas
San Antonio, Texas, 78154
United States
San Antonio Eye Center
San Antonio, Texas, 78215
United States
Retina Associates of South Texas
San Antonio, Texas, 78240
United States
Tyler Retina Consultants
Tyler, Texas, 75703
United States
Retina Associates of Utah
Salt Lake City, Utah, 84107
United States
Salt Lake Retina
West Jordan, Utah, 84088
United States
The Retina Group of Washington
Fairfax, Virginia, 22031
United States
Emerson Clinical Research Institute
Falls Church, Virginia, 22046
United States
Piedmont Eye Center
Lynchburg, Virginia, 24502
United States
Virginia Retina Center
Warrenton, Virginia, 20186
United States
Pacific Northwest Retina
Bellevue, Washington, 98004
United States

Collaborators and Investigators

Sponsor: EyePoint Pharmaceuticals, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-11-27
Study Completion Date2027-10

Study Record Updates

Study Start Date2024-11-27
Study Completion Date2027-10

Terms related to this study

Keywords Provided by Researchers

  • Wet Age-related Macular Degeneration
  • Tyrosine Kinase Inhibitor
  • EYP-1901
  • EyePoint

Additional Relevant MeSH Terms

  • Wet Age Related Macular Degeneration
  • wAMD