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)
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.
100 项与 Tiespectus 相关的临床结果
100 项与 Tiespectus 相关的转化医学
100 项与 Tiespectus 相关的专利(医药)
100 项与 Tiespectus 相关的药物交易