ACTIVE_NOT_RECRUITING

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

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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:2024-10-22
Study Completion:2027-08
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06668064

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)

Retinal Research Institute, LLC
Phoenix, Arizona, 85053
United States
Retina Partners of Northwest Arkansas
Springdale, Arkansas, 72764
United States
California Retina Consultants
Bakersfield, California, 93309
United States
Retina Vitreous Associates Medical Group
Beverly Hills, California, 90211
United States
Macula and Retina Institute
Glendale, California, 91203
United States
Gavin Herbert Eye Institute
Irvine, California, 92697
United States
Retina Consultants San Diego
Poway, California, 92064
United States
Retina Consultants of Southern California
Redlands, California, 92374
United States
Retinal Consultants Medical Group
Sacramento, California, 95841
United States
West Coast Retina Medical Group
San Francisco, California, 94109
United States
Bay Area Retina Associates
Walnut Creek, California, 94598
United States
American Institute of Research
Whittier, California, 95008
United States
RSC Research, PLLC
Denver, Colorado, 80210
United States
Eye Center of Northern Colorado, PC
Fort Collins, Colorado, 80528
United States
Advanced Vision Institute
Longmont, Colorado, 80503
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
Advanced Research, LLC
Deerfield Beach, Florida, 33064
United States
Vitreo Retinal Associates
Gainesville, Florida, 32607
United States
Florida Retina Consultants
Lakeland, Florida, 33805
United States
Florida Retina Institute
Orlando, Florida, 32806
United States
Retina Specialty Institute
Pensacola, Florida, 32503
United States
Eye Associates of Pinellas
Pinellas Park, Florida, 33782
United States
Retina Group of Florida
Sarasota, Florida, 34232
United States
MedEye Associates
South Miami, Florida, 33143
United States
Retina Specialists of Tampa
Tampa, Florida, 33544
United States
Retina Vitreous Associates of Florida
Tampa, Florida, 33617
United States
Center for Retina & Macular Disease
Winter Haven, Florida, 33880
United States
Gerogia Retina
Marietta, Georgia, 30060
United States
Retina Consultants of Hawaii
Aiea, Hawaii, 96701
United States
Retina Associates
Elmhurst, Illinois, 60126
United States
University Retina and Macula Associates
Lemont, Illinois, 60439
United States
Midwest Eye Institute
Carmel, Indiana, 46290
United States
Retina Associates LLC
Lenexa, Kansas, 66215
United States
Maine Eye Center
Portland, Maine, 04101
United States
The Retina Care Center
Baltimore, Maryland, 21209
United States
Retina Groups of Washington
Chevy Chase, Maryland, 20815
United States
Cumberland Valley Retina Consultants
Hagerstown, Maryland, 21740
United States
Retina Specialists
Towson, Maryland, 21204
United States
Ophthalmic Consultants of Boston OCB - Boston
Boston, Massachusetts, 02114
United States
New England Retina Consultants
Springfield, Massachusetts, 01107
United States
Retina Associates of Michigan
Grand Blanc, Michigan, 48439
United States
Foundation for Vision Research
Grand Rapids, Michigan, 49546
United States
Deep Blue Retina Clinical Research PLLC
Southaven, Mississippi, 38671
United States
The Retina Institute
St Louis, Missouri, 63128
United States
Sierra Eye Associates
Reno, Nevada, 89502
United States
NJ Retina
Teaneck, New Jersey, 07666
United States
NJ Retina
Toms River, New Jersey, 08755
United States
Vision Research Center at Eye Associates of New Mexico
Albuquerque, New Mexico, 87109
United States
Retina Vitreous Surgeons of CNY, PC
Liverpool, New York, 13088
United States
Retina Associates of Western NY, PC
Rochester, New York, 14620
United States
Retina Consultants PLLC
Slingerlands, New York, 12159
United States
Western Carolina Retinal Associates, PA
Asheville, North Carolina, 28803
United States
Cape Fear Retinal Associates, PC
Wilmington, North Carolina, 28401
United States
Piedmont Retina Specialists, P.A. - Winston-Salem Office
Winston Salem, North Carolina, 27103
United States
Midwest Retina, Inc.
Dublin, Ohio, 43016
United States
Tulsa Retina Consultant
Tulsa, Oklahoma, 74114
United States
Verum Research LLC
Eugene, Oregon, 97401
United States
Erie Retina Research
Erie, Pennsylvania, 16507
United States
Eye Care Specialists - Kingston Location
Kingston, Pennsylvania, 18704
United States
Retina Consultants
Charleston, South Carolina, 29414
United States
Palmetto Retina Center
Florence, South Carolina, 29169
United States
Retina Consultants of Carolina P.A
Greenville, South Carolina, 29605
United States
Charles Retina Institute
Germantown, Tennessee, 38138
United States
Retina Research Institute of Texas Integrated Clinical Research
Abilene, Texas, 79606
United States
Retina and Vitreous of Texas
Bellaire, Texas, 77401
United States
Retina Consultants of Texas (Retina Consultants of Houston) - Woodlands
Bellaire, Texas, 77401
United States
Texas Retina Associates
Dallas, Texas, 75231
United States
Houston Eye Associates
Houston, Texas, 77025
United States
Baylor College of Medicine Alkek Eye Center
Houston, Texas, 77030
United States
Texas Retina Associates
Plano, Texas, 75075
United States
San Antonio Eye Center
San Antonio, Texas, 78215
United States
Retinal Consultants of Texas
San Antonio, Texas, 78240
United States
Retina Center of Texas
Southlake, Texas, 76092
United States
Retina Consultants of Texas
The Woodlands, Texas, 77384
United States
Tyler Retina Consultants
Tyler, Texas, 75703
United States
Strategic Clinical Research Group, LLC
Willow Park, Texas, 76087
United States
Retina Associates of Utah
Salt Lake City, Utah, 84107
United States
Rocky Mountain Retina Consultants
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
Piedmont Eye Center
Lynchburg, Virginia, 24502
United States
Retina Associates, P.C.
Winchester, Virginia, 22601
United States
University of Wisconsin School of Medicine and Public Health (UWSMPH)
Madison, Wisconsin, 53705
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 Date2024-10-22
Study Completion Date2027-08

Study Record Updates

Study Start Date2024-10-22
Study Completion Date2027-08

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