Clinical Research Directory

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.

A 3-month Study to Compare the Safety of ONS-5010 in Vials Versus Pre-filled Syringe in Subjects With Visual Impairment Due to Retinal Disorders

The study will compare the safety of ophthalmic bevacizumab in vials versus pre-filled syringes in subjects diagnosed with a retinal condition that would benefit from treatment with intravitreal injection of bevacizumab, including: exudative age-related macular degeneration, diabetic macular edema, or branch retinal vein occlusion.