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

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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
Enrollment count 
90 participants
Start date 
Jan 23, 2019
Completion date 
Feb 09, 2021
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

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
Reno, 89502
Nevada
United States
Novartis Investigative Site
Recruiting
Rapid City, 57701
South Dakota
United States
Novartis Investigative Site
Recruiting
Austin, 78793
Texas
United States
Novartis Investigative Site
Recruiting
Houston, 77025
Texas
United States
Novartis Investigative Site
Recruiting
San Antonio, 78240
Texas
United States
Germany
Novartis Investigative Site
Recruiting
Berlin, 13353
-
Germany
Novartis Investigative Site
Recruiting
Gottingen, 37075
-
Germany
Novartis Investigative Site
Recruiting
Hannover, 30625
-
Germany
Novartis Investigative Site
Recruiting
Muenster, 48145
-
Germany
Novartis Investigative Site
Recruiting
Tuebingen, 72076
-
Germany
Puerto Rico
Novartis Investigative Site
Recruiting
Arecibo, 00612
-
Puerto Rico
Spain
Novartis Investigative Site
Recruiting
Sevilla, 41009
Andalucia
Spain
Novartis Investigative Site
Recruiting
Barcelona, 08036
Catalunya
Spain
Novartis Investigative Site
Recruiting
Sant Cugat, 08190
Catalunya
Spain
Novartis Investigative Site
Recruiting
Barcelona, 08025
Cataluña
Spain
Novartis Investigative Site
Recruiting
Zaragoza, 50009
-
Spain

Contacts

Name: 
Novartis Pharmaceuticals
Phone: 
1-888-669-6682
Name: 
Novartis Pharmaceuticals
Phone: 
+41613241111
Email: 

Have a question?

Call 1-999-669-6682 or email [email protected]