To evaluate the safety and tolerability of LKA651 in patients with macular edema from diabetic macular edema (DME), neovascular age-related macular degeneration (AMD), or retinal vein occlusions (RVO)
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
28
Interventional
Novartis Investigative Site
Pasadena, California, United States
Novartis Investigative Site
Fort Myers, Florida, United States
Novartis Investigative Site
Miami, Florida, United States
Novartis Investigative Site
Winter Haven, Florida, United States
Number Of participants with Adverse Events as a measure of Safety and Tolerability
To evaluate the safety and tolerability of LKA651 by reviewing any adverse events after medical or ophthalmic examinations that are possibly or probably related to study drug.
Time frame: Day 1 through study completion
Pharmacokinetics of Single Dose of LKA651 - Area Under the Curve (AUC)
To evaluate the serum pharmacokinetic profile of LKA651 Measured by AUC(0-last) - Area under the plasma concentration time curve from time zero to the last quantifiable concentration-time point.
Time frame: Plasma samples were collected at Days 1,2,5,8,15,29,43,57,71,85
Pharmacokinetics of Single Dose of LKA651 - Cmax
To evaluate the serum pharmacokinetic profile of LKA651 Measured by Cmax - The maximum plasma concentration of study medication.
Time frame: Plasma samples were collected at Days 1,2,5,8,15,29,43,57,71,85
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Novartis Investigative Site
Augusta, Georgia, United States
Novartis Investigative Site
Arecibo, Puerto Rico