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
Running, not enrolling · Phase 1/Phase 2
Conditions studied: Diabetic Macular Edema (DME), Neovascular Age-related Macular Degeneration (NVAMD), BRVO - Branch Retinal Vein Occlusion
In brief
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.
Key facts
- Study ID
- NCT06664502
- Run by
- EyeBiotech Ltd.
- People needed
- 38
- Starts
- 2024-11-12
- Expected to finish
- 2026-08-11
- Last updated by the study team
- 2026-05-28
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- 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
Full record on ClinicalTrials.gov
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