Phase I Dose Escalation and Expansion Study of DS-7080a in Subjects With Neovascular Age-related Macular Degeneration or Diabetic Macular Edema
The purpose of this study is to test DS-7080a, a monoclonal antibody, as a new treatment for neovascular age-related macular degeneration (AMD) and diabetic macular edema (DME). The hypothesis of the study is that DS-7080a is safe and shows preliminary efficacy in patients with these conditions either alone or in combination with ranibizumab. This study is organized into 3 Parts: Part 1 Dose Escalation in AMD participants, Part 2 Dose Expansion in AMD participants, and Part 3 Dose Expansion in DME participants. In Part 1, participants will be enrolled into 3 sequential, ascending dose-level cohorts in non-randomized uncontrolled manner with the main purpose to determine the recommended dose. In Part 2, participants will be randomized to 1 of 3 arms of either monotherapy with DS-7080a or monotherapy with ranibizumab, which is an active control, or combination therapy of DS-7080a plus ranibizumab (ranibizumab will be administered 30 minutes prior to DS-7080a). In Part 3, subjects with DME will be assigned to 1 of 2 arms of either monotherapy with DS-7080a or monotherapy with ranibizumab. DS-7080a or ranibizumab will be administered 3 times: on Baseline/Day 1, Day 29, and Day 57. Both Parts 2 and 3 will consist of 8 visits including a 14-day screening phase, an 84-day treatment period, and a 28-day follow-up period.
⁃ For parts 1 and 2:
• ≥ 50 years of age
• Has active primary subfoveal choroid neovascularization (CNV) lesions secondary to age-related macular degeneration (AMD)
• CNV ≥ 50% of total lesion size in study eye
• Central sub-field thickness \> 315 µm on spectral domain optical coherence tomography (SD-OCT) in the study eye
• Has BCVA letter score required at screening visit:
• For Part 1, ≤ 49 (approximately 20/100 or worse) in the study eye and ≥ 49 (approximately 20/100 or better) in the fellow eye
• For Part 2, 78 to 25 (approximately 20/32 to 20/320) in the study eye
⁃ For Part 3:
• Is ≥ 18 years of age with retinal thickening due to diabetic macular edema (DME)
• Has central sub-field thickness (CST) \> 335 μm in the study eye
• Has BCVA letter score at screening visit 78 to 25 letters (approximately 20/32 to 20/320) in the study eye