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A 2-part Study Consisting of a Multiple Ascending Dose Safety Study in Participants With Macular Edema Following Branch Retinal Vein Occlusion and a Dose-finding Safety and Preliminary Efficacy Study in Participants With Either Diabetic Macular Edema or Neovascular Age-related Macular Degeneration
Sponsor: EyeBiotech Ltd.
Summary
EYE-TIE-201 is a 2-part study to investigate the safety and effectiveness of a new drug being developed called EYE201. All participants in the study will receive a total of 3 injections of EYE201 into the study eye, spaced at 4 weeks apart. In the first part, termed the multiple ascending dose (MAD) portion of study, the safety of EYE201 will be assessed at increasing doses in branch retinal vein occlusion (BRVO) participants. Approximately 12 participants will be entered in this part of the study. In the second part of the study, called the dose finding part, 2 doses of EYE201 will be selected and their effectiveness will be compared. This portion of the study assesses the safety and preliminary efficacy of EYE201 in patients with diabetic macular edema (DME) or neovascular macular degeneration (NVAMD). Approximately 80 participants will be entered in this part of the study.
Official title: A Phase 1/2a 2-part Study Consisting of an Open-label Multiple Ascending Dose (MAD) Safety Study in Participants With Macular Edema Following Branch Retinal Vein Occlusion (BRVO), and a Dose-finding, Double-masked, Comparative Safety, and Preliminary Efficacy Study of Intravitreal (IVT) EYE201 (Tiespectus) in Participants With Either Diabetic Macular Edema (DME) or Neovascular Age-related Macular Degeneration (NVAMD)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
38
Start Date
2024-11-12
Completion Date
2026-05-31
Last Updated
2026-03-18
Healthy Volunteers
No
Conditions
Interventions
EYE201
EYE201 solution for intravitreal administration
Locations (27)
Scottsdale, Arizona
Scottsdale, Arizona, United States
Modesto, CA
Modesto, California, United States
Mountain View, California
Mountain View, California, United States
Sacramento, CA
Sacramento, California, United States
Sacramento, California
Sacramento, California, United States
Deerfield Beach, FL
Deerfield Beach, Florida, United States
Lemont, IL
Lemont, Illinois, United States
Hagerstown, Maryland
Hagerstown, Maryland, United States
Madison, Mississippi
Madison, Mississippi, United States
Bloomfield, New Jersey
Bloomfield, New Jersey, United States
Asheville, NC
Asheville, North Carolina, United States
Wake Forest, NC
Wake Forest, North Carolina, United States
West Columbia, South Carolina
West Columbia, South Carolina, United States
Germantown, Tennessee
Germantown, Tennessee, United States
Knoxville, TN
Knoxville, Tennessee, United States
Nashville, Tennessee
Nashville, Tennessee, United States
Abilene, Texas
Abilene, Texas, United States
Amarillo, Texas
Amarillo, Texas, United States
Austin, Texas
Austin, Texas, United States
Bellaire, Texas
Bellaire, Texas, United States
Bellaire, TX
Bellaire, Texas, United States
Dallas, Texas
Dallas, Texas, United States
Plano, TX
Plano, Texas, United States
Round Rock, TX
Round Rock, Texas, United States
San Antonio, Texas
San Antonio, Texas, United States
Woodlands, Texas
The Woodlands, Texas, United States
Arecibo, PR
Arecibo, Puerto Rico