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A 2-part Study Consisting of Multiple Ascending Dose (MAD) Safety Study, and a Dose-finding Masked Study to Assess the Safety and Efficacy of Intravitreal (IVT) EYE103 in Patients With Diabetic Macular Edema (DME) or Neovascular Age-related Macular Degeneration (NVAMD)
Sponsor: EyeBiotech Ltd.
Summary
EYE103-101 is a 2-part study assessing safety and preliminary efficacy of EYE103 in patients with diabetic macular edema (DME) given as monotherapy or neovascular macular degeneration (NVAMD) given in combination with anti-VEGF. In the first part, termed the multiple ascending dose (MAD) portion of study, the safety of EYE103 will be assessed at escalating doses. Approximately 12 participants will be entered in this part of the study. In the second part of the study, called the dose finding part two doses of EYE103 will be selected and their effectiveness will be compared. Approximately 80 participants will be entered in this part of the study.
Official title: A 2-part Study Consisting of an Open-label Multiple Ascending Dose (MAD) Safety Study, and a Dose-finding Single-masked Comparative Safety and Preliminary Efficacy Study of Intravitreal (IVT) EYE103 in a Mixed Population of Participants With Diabetic Macular Edema (DME) or Neovascular Age-related Macular Degeneration (NVAMD)
Key Details
Gender
All
Age Range
50 Years - Any
Study Type
INTERVENTIONAL
Enrollment
33
Start Date
2023-06-12
Completion Date
2024-08-26
Last Updated
2026-09-29
Healthy Volunteers
No
Interventions
EYE103
EYE103 is a humanized antibody formulated for IVT administration
Locations (32)
Phoenix, AZ
Phoenix, Arizona, United States
Bakersfield, CA
Bakersfield, California, United States
Modesto, CA
Modesto, California, United States
Mountain View, CA
Mountain View, California, United States
Sacramento, CA
Sacramento, California, United States
Sacramento, CA
Sacramento, California, United States
Colorado Springs, Colorado
Colorado Springs, Colorado, United States
Lakewood, CO
Lakewood, Colorado, United States
Pompano Beach
Pompano Beach, Florida, United States
Lemont, NV
Lemont, Illinois, United States
Hagerstown, MD
Hagerstown, Maryland, United States
Reno, NV
Reno, Nevada, United States
West Columbia, SC
West Columbia, South Carolina, United States
Germantown, TN
Germantown, Tennessee, United States
Knoxville, TN
Knoxville, Tennessee, United States
Nashville, TN
Nashville, Tennessee, United States
Abilene, TX
Abilene, Texas, United States
Amarillo, TX
Amarillo, Texas, United States
Austin, TX
Austin, Texas, United States
Bellaire, TX
Bellaire, Texas, United States
Dallas, TX
Dallas, Texas, United States
Katy, TX
Katy, Texas, United States
McAllen, TX
McAllen, Texas, United States
Plano, TX
Plano, Texas, United States
Round Rock, TX
Round Rock, Texas, United States
San Antonio, TX
San Antonio, Texas, United States
The Woodlands, TX
The Woodlands, Texas, United States
Ciudad Autonoma Buenos Aires
Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina
Caba, Argentina
Caba, Argentina
Arecibo, PR
Arecibo, PR, Puerto Rico
London, England
London, England, United Kingdom
London, UK
London, United Kingdom