A Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamic Activity of Intravitreal LKA651 in Patients With Macular Edema
Macular Edema, Diabetic Macular Edema, Neovascular Age-related Macular Degeneration
About this trial
This is an interventional treatment trial for Macular Edema focused on measuring Macular Edema, Diabetic Macular Edema (DME), Neovascular age-related Macular Degeneration(AMD), Retinal Vein Occlusions (RVO)
Eligibility Criteria
Inclusion Criteria:
-Patients with macular edema with center involvement in at least one eye, including those with focal or diffuse DME, neovascular AMD, or RVO
The ETDRS letter score in the study eye must be 60 letters or worse (approximate Snellen equivalent of 20/63)
Vital signs as specified within the protocol
Exclusion Criteria:
-Proliferative diabetic retinopathy in the study eye, with the exception of tufts of neovascularization less than one disc area with no vitreous hemorrhage
Patient, with type 1 or type 2 diabetes who have a hemoglobin A1C > or = 12% at screening
other ocular conditions as specified in the protocol
systemic conditions as specified in the protocol
Sites / Locations
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
Arms of the Study
Arm 1
Arm 2
Experimental
Sham Comparator
LKA651
Sham Comparator