All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation.
To evaluate the safety and efficacy of LKA651 in patients with macular edema from diabetic macular edema (DME),
Diabetic Macular Edema
Mar 16, 2020
Jan 23, 2019
Feb 09, 2021
18 Years - 85 Years (Adult, Older Adult)
Written informed consent must be obtained before any assessment is performed.
Male and female patients age 18 to 85 years of age inclusive at screening
Presence of type I or type II diabetes mellitus
The ETDRS letter score in the study eye must be between 24 and 70 letters (approximate Snellen equivalent of 20/40-20/320). The non-study eye (fellow eye) should be ≥34 letters or better (approximate Snellen equivalent of 20/200) at screening
Presence of DME in the study eye, with decrease in vision due to foveal thickening of central macular thickness ≥ 320 µm in the central subfield, as assessed on SD-OCT and confirmed by the central reading center at screening
Other protocol specified inclusion/exclusion criteria apply.