Multiple Dose Safety and Efficacy of LKA651 in Patients With Diabetic Macular Edema

A Randomized, Active-controlled, Patient and Investigator-masked, Multiple Dose Proof-of-concept Study of Intravitreal LKA651 in Patients With Diabetic Macular Edema

ClinicalTrials.gov Identifier: NCT03927690

Novartis Reference Number: CLKA651X2202

Last Update: May 02, 2022

All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation.

Study Description

To evaluate the safety and efficacy of LKA651 in patients with macular edema from diabetic macular edema (DME),

Condition

Diabetic Macular Edema

Phase

Phase 2

Overall status

Recruiting

Start date

Jan 23, 2019

Completion date

Aug 19, 2022

Gender

All

Age(s)

18 Years - 85 Years (Adult, Older Adult)

Interventions

Drug

LKA651

LKA651 IVT

Drug

LKA651

LKA651 IVT

Drug

Lucentis

Lucentis IVT

Drug

Lucentis

Lucentis IVT

Drug

LKA651

LKA651 IVT

Drug

LKA651

LKA651 IVT

Drug

Lucentis

Lucentis IVT

Drug

Lucentis

Lucentis IVT

Eligibility Criteria

Inclusion Criteria

Written informed consent must be obtained before any assessment is performed.
Male and female patients age 18 to 85 years of age inclusive at screening
Presence of type I or type II diabetes mellitus
The ETDRS letter score in the study eye must be between 24 and 70 letters (approximate Snellen equivalent of 20/40-20/320). The non-study eye (fellow eye) should be ≥34 letters or better (approximate Snellen equivalent of 20/200) at screening
Presence of DME in the study eye, with decrease in vision due to foveal thickening of central macular thickness ≥ 320 µm in the central subfield, as assessed on SD-OCT and confirmed by the central reading center at screening

Other protocol specified inclusion/exclusion criteria apply.