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A Dose-masked Study of Intravitreal EYE103 in Participants With NVAMD or Macular Edema Following BRVO
Sponsor: EyeBiotech Ltd.
Summary
EYE-RES-104 is a randomized, dose-masked study of intravitreal EYE103 in participants with neovascular age-related macular degeneration (NVAMD) or macular edema following branch retinal vein occlusion (BRVO). The study will consist of 4 patient cohorts, with participants in each cohort randomized (1:1) to either a low dose of EYE103 via IVT or a high dose of EYE103 via IVT. 40 participants will be enrolled in each cohort. Enrollment timing for each cohort will be sequenced into specific arms of the study at the Sponsor's discretion. All participants in the study will receive a total of 3 injections of EYE103 into the study eye, spaced at 4 weeks apart. All participants will return at designated time points following each injection for safety and efficacy assessments. The Week 12 Visit will serve as the end of study visit for all participants.
Official title: A Phase 2 Randomized, Dose-Masked Study of Intravitreal EYE103 in Participants With Neovascular Age-Related Macular Degeneration (NVAMD) or Macular Edema Following Branch Retinal Vein Occlusion (BRVO)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
160
Start Date
2025-09-12
Completion Date
2028-06-30
Last Updated
2025-11-19
Healthy Volunteers
No
Interventions
EYE103
EYE103 is a humanized antibody formulated for intravitreal administration
Aflibercept 2.0 mg
Aflibercept 2.0 mg is a commercially available anti-VEGF treatment formulated for intravitreal administration for use in patients with Neovascular Age-Related Macular Degeneration (NVAMD). Aflibercept 2.0 mg is only administered to 2 cohorts of Incomplete Responders (IR) with NVAMD in combination with Low Dose or High Dose EYE103.
Locations (49)
Scottsdale, Arizona
Scottsdale, Arizona, United States
Scottsdale, AZ
Scottsdale, Arizona, United States
Glendale, California
Glendale, California, United States
Glendale, CA
Glendale, California, United States
Modesto, California
Modesto, California, United States
Mountain View, California
Mountain View, California, United States
Sacramento, CA
Sacramento, California, United States
Sactamento, California
Sacramento, California, United States
Sacramento, California
Sacramento, California, United States
Santa Ana, California
Santa Ana, California, United States
Fort Lauderdale, Florida
Fort Lauderdale, Florida, United States
Fort Lauderdale, FL
Fort Lauderdale, Florida, United States
Lemont, Illinois
Lemont, Illinois, United States
Lemont, IL
Lemont, Illinois, United States
Hagerstown, Maryland
Hagerstown, Maryland, United States
Hagerstown, MD
Hagerstown, Maryland, United States
Madison, Mississippi
Madison, Mississippi, United States
Madison, MS
Madison, Mississippi, United States
Bloomfield, New Jersey
Bloomfield, New Jersey, United States
Bloomfield, NJ
Bloomfield, New Jersey, United States
Asheville, North Carolina
Asheville, North Carolina, United States
Cary, North Carolina
Cary, North Carolina, United States
Wake Forest, NC
Wake Forest, North Carolina, United States
Wake Forest, North Carolina
Wake Forest, North Carolina, United States
West Columbia, SC
West Columbia, South Carolina, United States
West Columbia, South Carolina
West Columbia, South Carolina, United States
Germantown, Tennessee
Germantown, Tennessee, United States
Knoxville, Tennessee
Knoxville, Tennessee, United States
Nashville, Tennessee
Nashville, Tennessee, United States
Nashville, TN
Nashville, Tennessee, United States
Abilene, Texas
Abilene, Texas, United States
Amarillo, Texas
Amarillo, Texas, United States
Austin, Texas
Austin, Texas, United States
Austin, TX
Austin, Texas, United States
Bellaire, Texas
Bellaire, Texas, United States
Bellaire, TX
Bellaire, Texas, United States
Burleson, Texas
Burleson, Texas, United States
Dallas, Texas
Dallas, Texas, United States
Dallas, TX
Dallas, Texas, United States
Plano, Texas
Plano, Texas, United States
Round Rock, TX
Round Rock, Texas, United States
Round Rock, Texas
Round Rock, Texas, United States
San Antonio, Texas
San Antonio, Texas, United States
San Antonio, TX
San Antonio, Texas, United States
San Marcos, Texas
San Marcos, Texas, United States
The Woodlands, Texas
The Woodlands, Texas, United States
The Woodlands, TX
The Woodlands, Texas, United States
Willow Park, Texas
Willow Park, Texas, United States
West Jordan, Utah
West Jordan, Utah, United States