A Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamic Activity of Intravitreal LKA651 in Patients With Macular Edema
Completed · Phase 1 · Has a placebo group
Conditions studied: Macular Edema, Diabetic Macular Edema, Neovascular Age-related Macular Degeneration, Retinal Vein Occlusions
In brief
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)
Key facts
- Study ID
- NCT02867735
- Run by
- Novartis Pharmaceuticals
- People needed
- 28
- Starts
- 2016-09-21
- Expected to finish
- 2018-02-15
- Last updated by the study team
- 2022-04-15
Who can join
Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Novartis Investigative Site — Pasadena, California, United States
- Novartis Investigative Site — Fort Myers, Florida, United States
- Novartis Investigative Site — Miami, Florida, United States
- Novartis Investigative Site — Winter Haven, Florida, United States
- Novartis Investigative Site — Augusta, Georgia, United States
- Novartis Investigative Site — Arecibo, Puerto Rico
Full record on ClinicalTrials.gov
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