Overview
A Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamic Activity of Intravitreal LKA651 in Patients With Macular Edema
Status:
Completed
Completed
Trial end date:
2018-02-15
2018-02-15
Target enrollment:
0
0
Participant gender:
All
All
Summary
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)Phase:
Phase 1Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Novartis Pharmaceuticals
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