Back to resultsA Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamic Activity of Intravitreal LKA651 in Patients With Macular Edema
Primary Purpose
Macular Edema, Diabetic Macular Edema, Neovascular Age-related Macular Degeneration
Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
LKA651
Sham Comparator
Sponsored by
About this trial
This is an interventional treatment trial for Macular Edema focused on measuring Macular Edema, Diabetic Macular Edema (DME), Neovascular age-related Macular Degeneration(AMD), Retinal Vein Occlusions (RVO)
Eligibility 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
Sites / Locations
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
LKA651
Sham Comparator
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02867735
Brief Title
A Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamic Activity of Intravitreal LKA651 in Patients With Macular Edema
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)
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
September 21, 2016 (Actual)
Primary Completion Date
February 15, 2018 (Actual)
Study Completion Date
February 15, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Macular Edema, Diabetic Macular Edema, Neovascular Age-related Macular Degeneration, Retinal Vein Occlusions
Keywords
Macular Edema, Diabetic Macular Edema (DME), Neovascular age-related Macular Degeneration(AMD), Retinal Vein Occlusions (RVO)
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
N/A
Enrollment
28 (Actual)
8. Arms, Groups, and Interventions
Arm Title
LKA651
Arm Type
Experimental
Arm Title
Sham Comparator
Arm Type
Sham Comparator
Intervention Type
Drug
Intervention Name(s)
LKA651
Intervention Description
Interventional
Intervention Type
Other
Intervention Name(s)
Sham Comparator
Primary Outcome Measure Information:
Title
Number Of participants with Adverse Events as a measure of Safety and Tolerability
Description
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.
Time Frame
Day 1 through study completion
Secondary Outcome Measure Information:
Title
Pharmacokinetics of Single Dose of LKA651 - Area Under the Curve (AUC)
Description
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.
Time Frame
Plasma samples were collected at Days 1,2,5,8,15,29,43,57,71,85
Title
Pharmacokinetics of Single Dose of LKA651 - Cmax
Description
To evaluate the serum pharmacokinetic profile of LKA651 Measured by Cmax - The maximum plasma concentration of study medication.
Time Frame
Plasma samples were collected at Days 1,2,5,8,15,29,43,57,71,85
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Novartis Investigative Site
City
Pasadena
State/Province
California
ZIP/Postal Code
91105-3153
Country
United States
Facility Name
Novartis Investigative Site
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33901
Country
United States
Facility Name
Novartis Investigative Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33143
Country
United States
Facility Name
Novartis Investigative Site
City
Winter Haven
State/Province
Florida
ZIP/Postal Code
33880
Country
United States
Facility Name
Novartis Investigative Site
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30909
Country
United States
Facility Name
Novartis Investigative Site
City
Arecibo
ZIP/Postal Code
00612
Country
Puerto Rico
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing 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
Learn more about this trial
A Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamic Activity of Intravitreal LKA651 in Patients With Macular Edema
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