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.
• Written informed consent before the first study-related activity
• Be male or female ≥ 18 years of age
• If female, have a negative serum pregnancy test at Screening and further negative urine tests immediately before each dose of study medication if the participant is a female of childbearing potential.
⁃ Participants must:
• Be diagnosed with BRVO in the study eye
• Have a ETDRS BCVA letter score between ≤ 70 and ≥ 35 (20/40 to 20/200 Snellen equivalent) in the study eye
• Have a CST of ≥ 325 μm in the study eye on SDOCT as determined by the IRC at Screening
• Have a decrease in vision in the study eye determined by the Investigator to be primarily the result of BRVO BRVO-specific Exclusion Criteria
⁃ Participants must not:
• Have macular edema in the study eye considered to be secondary to a cause other than BRVO (e.g., DME, Irvine-Gass syndrome)
• Have active iris or angle neovascularization or neovascular glaucoma in the study eye
• Have proliferative retinopathy, central retinal vein occlusion, or hemiretinal vein occlusion
⁃ Participants must:
• Have Type 1 or Type 2 diabetes mellitus and a glycated hemoglobin A1c (HbA1c) of ≤ 12%
• Have a ETDRS BCVA letter score between ≤ 70 and ≥ 35 (20/40 to 20/200 Snellen equivalent) in the study eye
• Have a CST of ≥ 325 μm in the study eye on SDOCT as determined by the IRC at Screening
• Have a decrease in vision in the study eye determined by the Investigator to be primarily the result of DME
⁃ Participants must:
• Be ≥ 50 years of age
• Have a ETDRS BVCA letter score between ≤ 70 and ≥ 35 (20/40 to 20/200 Snellen equivalent) in the study eye
• Subfoveal CNV secondary to AMD, with a total lesion size (including blood, scar/atrophy \& neovascularization) of ≤ 9-disc areas, of which at least 50% must be active CNV in the study eye
• Have a CST of ≥ 325 μm in the study eye on SDOCT as determined by the IRC at Screening
• Be treatment naïve with vision loss in the study eye secondary to NVAMD diagnosed within 21 days prior to the Day 1 study treatment NVAMD-specific Exclusion Criteria
⁃ Participants must not:
• Have had previous thermal subfoveal laser therapy in the study eye
• Have any subfoveal atrophy or scarring, blood over the fovea, or subfoveal fibrosis in the study eye. Additionally, no more than 25% of the total lesion size may be made up of scarring or atrophy
• Have had previous photodynamic therapy with Visudyne in the study eye
• Have diabetic retinopathy in the study eye