Study of DS-7080a for the Treatment of Macular Degeneration

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

Status Completed

Clinical Trial Summary

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.

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• Diabetic Macular Edema
• Macular Degeneration
• Macular Edema
• Neovascular Age-Related Macular Degeneration
• Wet Macular Degeneration

• NCT number: NCT02530918
• Study type: Interventional
• Source: Daiichi Sankyo, Inc.
• Status: Completed
• Phase: Phase 1
• Start date: July 2015
• Completion date: January 2, 2018