Diabetic Macular Edema Clinical Trial
Official title:
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.
n/a
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