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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02867735
Recruitment Status : Completed
First Posted : August 16, 2016
Last Update Posted : July 12, 2018
Sponsor:
Information provided by (Responsible Party):
Novartis ( 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)

Condition or disease Intervention/treatment Phase
Macular Edema Diabetic Macular Edema Neovascular Age-related Macular Degeneration Retinal Vein Occlusions Drug: LKA651 Other: Sham Comparator Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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)
Actual Study Start Date : September 21, 2016
Actual Primary Completion Date : February 15, 2018
Actual Study Completion Date : February 15, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: LKA651 Drug: LKA651
Interventional

Sham Comparator: Sham Comparator Other: Sham Comparator



Primary Outcome Measures :
  1. Number Of participants with Adverse Events as a measure of Safety and Tolerability [ Time Frame: 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 :
  1. Pharmacokinetics of Single Dose of LKA651 - Area Under the Curve (AUC) [ Time Frame: 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.

  2. Pharmacokinetics of Single Dose of LKA651 - Cmax [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02867735


Locations
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United States, California
Novartis Investigative Site
Pasadena, California, United States, 91105-3153
United States, Florida
Novartis Investigative Site
Fort Myers, Florida, United States, 33901
Novartis Investigative Site
Miami, Florida, United States, 33143
Novartis Investigative Site
Winter Haven, Florida, United States, 33880
United States, Georgia
Novartis Investigative Site
Augusta, Georgia, United States, 30909
United States, Pennsylvania
Novartis Investigative Site
Hagerstown, Pennsylvania, United States, 21740
Puerto Rico
Novartis Investigative Site
Arecibo, Puerto Rico, 00612
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals

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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02867735     History of Changes
Other Study ID Numbers: CLKA651X2104
First Posted: August 16, 2016    Key Record Dates
Last Update Posted: July 12, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description:

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com


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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Macular Edema
Diabetic Macular Edema (DME)
Neovascular age-related Macular Degeneration(AMD)
Retinal Vein Occlusions(RVO)

Additional relevant MeSH terms:
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Macular Degeneration
Macular Edema
Retinal Vein Occlusion
Wet Macular Degeneration
Edema
Signs and Symptoms
Retinal Degeneration
Retinal Diseases
Eye Diseases
Venous Thrombosis
Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases