A Study to Evaluate the Safety and Tolerability of EXN407

Summary

This first in human (FIH), Phase Ib/II study of EXN407 is a randomised, double-masked, vehicle-controlled, multiple dose, dose-escalating study to evaluate the safety and tolerability of EXN407 in subjects with centre involved Diabetic Macular Oedema (DMO), with Centre-subfield macular thickness (CMT) between 280-420 µm and Best corrected visual acuity (BCVA) better than or equal to 69 ETDRS score (approximate Snellen equivalent 20/40 (6/12 letters) in the study eye, which is considered secondary to diabetes mellitus. This study will provide a basis for further clinical development of EXN407 ophthalmic solution.

Timeline

Start

2020-11-05

Primary completion

2022-10-25

Completion

2022-11-29

Drugs

Indications