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

Novartis

Status and phase: Completed; Phase 1

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

Treatments: Drug: LKA651; Other: Sham Comparator

Study type: Interventional

Funder types: Industry

Identifiers

NCT02867735

CLKA651X2104

Details and patient eligibility

About

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)

Enrollment: 28 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Sequential Assignment

Masking: Quadruple Blind

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28 participants in 2 patient groups

LKA651

Experimental group

Treatment:

Drug: LKA651

Sham Comparator

Sham Comparator group

Treatment:

Other: Sham Comparator