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

Phase 1

Completed

• Conditions: Macular Edema; Retinal Vein Occlusions; Diabetic Macular Edema; Neovascular Age-related Macular Degeneration
• Interventions: Drug: LKA651; Other: Sham Comparator

• Registration Number: NCT02867735
• Lead Sponsor: Novartis Pharmaceuticals

Brief 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)

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-08-09
• Study First Submitted QC: 2016-08-12
• Study First Posted: 2016-08-16
• Study Start: 2016-09-21
• Primary Completion: 2018-02-15
• Study Completion: 2018-02-15
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-08
• Last Update Posted: 2022-04-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
LKA651	LKA651	-
Sham Comparator	Sham Comparator	-

Primary Outcome Measures

Name	Time	Method
Number Of participants with Adverse Events as a measure of Safety and Tolerability	Day 1 through study completion	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.

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetics of Single Dose of LKA651 - Area Under the Curve (AUC)	Plasma samples were collected at Days 1,2,5,8,15,29,43,57,71,85	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.
Pharmacokinetics of Single Dose of LKA651 - Cmax	Plasma samples were collected at Days 1,2,5,8,15,29,43,57,71,85	To evaluate the serum pharmacokinetic profile of LKA651 Measured by Cmax - The maximum plasma concentration of study medication.

Trial Locations

Locations (1)

Novartis Investigative Site; 🇵🇷 Arecibo, Puerto Rico