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

See if you pre-qualify

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.

Study Locations

United States
Novartis Investigative Site
Recruiting
Beverly Hills, 90211
California
United States
Novartis Investigative Site
Recruiting
Miami, 33143
Florida
United States
Novartis Investigative Site
Recruiting
'Aiea, 96701
Hawaii
United States
Novartis Investigative Site
Recruiting
Beverly Hills, 90211
California
United States
Novartis Investigative Site
Recruiting
Miami, 33143
Florida
United States
Novartis Investigative Site
Recruiting
'Aiea, 96701
Hawaii
United States
Turkey
Novartis Investigative Site
Recruiting
Ankara, 06100
-
Turkey
Novartis Investigative Site
Recruiting
Ankara, 06490
-
Turkey
Novartis Investigative Site
Recruiting
Ankara, 06500
-
Turkey
Novartis Investigative Site
Recruiting
Kocaeli, 41380
-
Turkey
Novartis Investigative Site
Recruiting
Ankara, 06100
-
Turkey
Novartis Investigative Site
Recruiting
Ankara, 06490
-
Turkey
Novartis Investigative Site
Recruiting
Ankara, 06500
-
Turkey
Novartis Investigative Site
Recruiting
Kocaeli, 41380
-
Turkey

Contacts

Name: 
Novartis Pharmaceuticals
Phone: 
Name: 
Novartis Pharmaceuticals
Phone: 
Name: 
Novartis Pharmaceuticals
Phone: 
Name: 
Novartis Pharmaceuticals
Phone: 

Have a question?

Call 1-888-669-6682 or email [email protected]