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

Diabetic Macular Edema Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02867735
• Other study ID #: CLKA651X2104
• Status: Completed
• Phase: Phase 1
• Start date: September 21, 2016
• Est. completion date: February 15, 2018

Study information

• Verified date: April 2022
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: February 15, 2018
• Est. primary completion date: February 15, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetic Macular Edema
• Edema
• Macular Degeneration
• Macular Edema
• Neovascular Age-related Macular Degeneration
• Retinal Vein Occlusion
• Retinal Vein Occlusions
• Wet Macular Degeneration

Intervention

Drug:
• LKA651
Interventional

Other:
• Sham Comparator

Locations

Country	Name	City	State
Puerto Rico	Novartis Investigative Site	Arecibo
United States	Novartis Investigative Site	Augusta	Georgia
United States	Novartis Investigative Site	Fort Myers	Florida
United States	Novartis Investigative Site	Miami	Florida
United States	Novartis Investigative Site	Pasadena	California
United States	Novartis Investigative Site	Winter Haven	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

United States,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Day 1 through study completion
Secondary	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.	Plasma samples were collected at Days 1,2,5,8,15,29,43,57,71,85
Secondary	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.	Plasma samples were collected at Days 1,2,5,8,15,29,43,57,71,85