Multiple Dose Safety and Efficacy of LKA651 in Patients With Diabetic Macular Edema
Study Details
Study Description
Brief Summary
To evaluate the safety and efficacy of LKA651 in patients with macular edema from diabetic macular edema (DME),
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
Phase 2 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: LKA651 LKA651 IVT |
Drug: LKA651
LKA651 IVT
|
Experimental: LKA651/Lucentis LKA651/Lucentis IVT |
Drug: LKA651
LKA651 IVT
Drug: Lucentis
Lucentis IVT
|
Active Comparator: Lucentis Lucentis IVT |
Drug: Lucentis
Lucentis IVT
|
Outcome Measures
Primary Outcome Measures
- Adverse event profile and safety endpoints of LKA651 [Day 169]
Incidence of treatment emergent adverse events and study drug related adverse events.
- Effect of LKA651 on Best Corrected Visual Acuity (BCVA) [Day 85]
To determine Best Corrected Visual Acuity (BCVA) as assessed by ETDRS (Early Treatment Diabetic Retinopathy Study) visual acuity charts
- Effect of LKA651 on Central subfield retinal thickness [Day 85]
Change from baseline in Central subfield retinal thickness as measured by SD-OCT
Secondary Outcome Measures
- Evaluate the time to retreatment with anti-VEGF [Day 169]
To determine the time to retreatment with anti-VEGF (as determined by PI) after week 12
- Cmax of LKA651 at steady state in patients with diabetic macular edema [Day 169]
To assess the Cmax of LKA651 at steady state in patients with diabetic macular edema
- Cmax of ranizumab at steady state in patients with diabetic macular edema [Day 169]
To assess the Cmax of ranizumab at steady state in patients with diabetic macular edema
- AUC0-28 of LKA651 at steady state in patients with diabetic macular edema [Day 169]
To assess the AUC0-28 of LKA651 at steady state in patients with diabetic macular edema
- AUC0-28 of ranizumab at steady state in patients with diabetic macular edema [Day 169]
To assess the AUC0-28 of ranizumab at steady state in patients with diabetic macular edema
- Effect of IVT LKA651 when administered alone or in combination with Lucentis® on DR progression in patients with DME [Day 169]
effect of IVT LKA651 when administered alone or in combination with Lucentis® on DR progression in patients with DME by improvement in the diabetic retinopathy severity scale by color fundus photos
Eligibility Criteria
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.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Novartis Investigative Site | Beverly Hills | California | United States | 90211 |
2 | Novartis Investigative Site | Rancho Cordova | California | United States | 95670 |
3 | Novartis Investigative Site | Miami | Florida | United States | 33143 |
4 | Novartis Investigative Site | Winter Haven | Florida | United States | 33880 |
5 | Novartis Investigative Site | 'Aiea | Hawaii | United States | 96701 |
6 | Novartis Investigative Site | Boston | Massachusetts | United States | 02118 |
7 | Novartis Investigative Site | Reno | Nevada | United States | 89502 |
8 | Novartis Investigative Site | Rapid City | South Dakota | United States | 57701 |
9 | Novartis Investigative Site | Austin | Texas | United States | 78750 |
10 | Novartis Investigative Site | Houston | Texas | United States | 77025 |
11 | Novartis Investigative Site | San Antonio | Texas | United States | 78240 |
12 | Novartis Investigative Site | Berlin | Germany | 13353 | |
13 | Novartis Investigative Site | Duesseldorf | Germany | 40212 | |
14 | Novartis Investigative Site | Gottingen | Germany | 37075 | |
15 | Novartis Investigative Site | Hannover | Germany | 30625 | |
16 | Novartis Investigative Site | Muenster | Germany | 48145 | |
17 | Novartis Investigative Site | Tuebingen | Germany | 72076 | |
18 | Novartis Investigative Site | Arecibo | Puerto Rico | 00612 | |
19 | Novartis Investigative Site | Sevilla | Andalucia | Spain | 41009 |
20 | Novartis Investigative Site | Barcelona | Catalunya | Spain | 08036 |
21 | Novartis Investigative Site | Sant Cugat | Catalunya | Spain | 08190 |
22 | Novartis Investigative Site | Barcelona | Spain | 08025 | |
23 | Novartis Investigative Site | Cordoba | Spain | 14012 | |
24 | Novartis Investigative Site | Zaragoza | Spain | 50009 | |
25 | Novartis Investigative Site | Ankara | Turkey | 06100 | |
26 | Novartis Investigative Site | Ankara | Turkey | 06490 | |
27 | Novartis Investigative Site | Ankara | Turkey | 06500 | |
28 | Novartis Investigative Site | Kocaeli | Turkey | 41380 |
Sponsors and Collaborators
- Novartis Pharmaceuticals
Investigators
- Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CLKA651X2202
- 2018-000031-28