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

Sponsor
Novartis Pharmaceuticals (Industry)
Overall Status
Recruiting
CT.gov ID
NCT03927690
Collaborator
(none)
90
28
3
39.2
3.2
0.1

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

Study Type:
Interventional
Anticipated Enrollment :
90 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Randomized, Active-controlled, Patient and Investigator-masked, Multiple Dose Proof-of-concept Study of Intravitreal LKA651 in Patients With Diabetic Macular Edema
Actual Study Start Date :
May 24, 2019
Anticipated Primary Completion Date :
Aug 29, 2022
Anticipated Study Completion Date :
Aug 30, 2022

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

  1. Adverse event profile and safety endpoints of LKA651 [Day 169]

    Incidence of treatment emergent adverse events and study drug related adverse events.

  2. 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

  3. 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

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

Ages Eligible for Study:
18 Years to 85 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No

Inclusion Criteria

  1. Written informed consent must be obtained before any assessment is performed.

  2. Male and female patients age 18 to 85 years of age inclusive at screening

  3. Presence of type I or type II diabetes mellitus

  4. 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

  5. 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.
Responsible Party:
Novartis Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT03927690
Other Study ID Numbers:
  • CLKA651X2202
  • 2018-000031-28
First Posted:
Apr 25, 2019
Last Update Posted:
Aug 9, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 9, 2022