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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)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LKA651 | Experimental |
| |
| Sham Comparator | Sham Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LKA651 | Drug | Interventional |
| |
| Sham Comparator |
| 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 |
| 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 |
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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
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Pasadena | California | 91105-3153 | United States | ||
| Novartis Investigative Site |
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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| Other |
|
| 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 |
| Fort Myers |
| Florida |
| 33901 |
| United States |
| Novartis Investigative Site | Miami | Florida | 33143 | United States |
| Novartis Investigative Site | Winter Haven | Florida | 33880 | United States |
| Novartis Investigative Site | Augusta | Georgia | 30909 | United States |
| Novartis Investigative Site | Arecibo | 00612 | Puerto Rico |
| ID | Term |
|---|---|
| D008269 | Macular Edema |
| D012170 | Retinal Vein Occlusion |
| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
| D020246 | Venous Thrombosis |
| D013927 | Thrombosis |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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