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

Overview

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)

Full Title of Study: “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)”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Sequential Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: February 15, 2018

Interventions

  • Drug: LKA651
    • Interventional
  • Other: Sham Comparator

Arms, Groups and Cohorts

  • Experimental: LKA651
  • Sham Comparator: Sham Comparator

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • 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.
  • 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.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 85 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Novartis Pharmaceuticals
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Novartis Pharmaceuticals, Study Director, Novartis Pharmaceuticals

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