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

Study Overview
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Brief Summary
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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)

Official Title
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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)

Conditions
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Macular Edema, Diabetic Macular Edema, Neovascular Age-related Macular Degeneration, Retinal Vein Occlusions

Intervention / Treatment
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* Drug: LKA651
* Other: Sham Comparator


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Sequential Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LKA651<br> | Drug: LKA651<br>* Interventional<br>|
| Sham Comparator: Sham Comparator<br> | Other: Sham Comparator<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Macular Edema, Diabetic Macular Edema (DME), Neovascular age-related Macular Degeneration(AMD), Retinal Vein Occlusions (RVO)