A Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamic Activity of Intravitreal LKA651 in Patients With Macular Edema



Status:Completed
Conditions:Cardiology, Ocular, Ocular, Ocular
Therapuetic Areas:Cardiology / Vascular Diseases, Ophthalmology
Healthy:No
Age Range:18 - 85
Updated:7/14/2018
Start Date:September 21, 2016
End Date:February 15, 2018

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Trial Summary
Trial Overview
Inclusion Criteria

A Randomized, Single-masked, Sham-control, Single Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamic Activity of Intravitreal LKA651 in Patients With Macular Edema From Diabetic Macular Edema (DME), Neovascular Age-related Macular Degeneration (AMD), or Retinal Vein Occlusions (RVO)

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)


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
We found this trial at
7
sites
Novartis Investigative Site
Hagerstown, Pennsylvania 21740
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Hagerstown, PA
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Novartis Investigative Site
Arecibo, 00612
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Arecibo,
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Novartis Investigative Site
Augusta, Georgia 30904
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Augusta, GA
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Novartis Investigative Site
Fort Myers, Florida 33912
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Fort Myers, FL
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Novartis Investigative Site
Miami, Florida 33136
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Miami, FL
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Novartis Investigative Site
Pasadena, California 91105
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Pasadena, CA
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Novartis Investigative Site
Winter Haven, Florida 33880
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Winter Haven, FL
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