Diabetic Macular Edema, Macular Edema, Neovascular Age-related Macular Degeneration, Retinal Vein Occlusions
Conditions
Keywords
Macular Edema, Diabetic Macular Edema (DME), Neovascular age-related Macular Degeneration(AMD), Retinal Vein Occlusions (RVO)
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)
Interventions
DRUGLKA651
Interventional
OTHERSham Comparator
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number Of participants with Adverse Events as a measure of Safety and Tolerability | 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
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetics of Single Dose of LKA651 - Area Under the Curve (AUC) | 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 | 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. |
Countries
Puerto Rico, United States
Outcome results
None listed