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

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.

NCT Number	NCT06664502
Lead Sponsor	EyeBiotech Ltd.
Conditions	Diabetic Macular Edema (DME), Neovascular Age-related Macular Degeneration (NVAMD), BRVO - Branch Retinal Vein Occlusion
Enrollment	38 participants
Start Date	2024-11-12
Primary Completion	2026-03-25 (estimated)
Study Completion	2026-08-11 (estimated)
Updated on ClinicalTrials.gov	2026-05-28