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

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ClinicalTrials.gov Identifier: NCT03927690
Recruitment Status : Recruiting
First Posted : April 25, 2019
Last Update Posted : November 2, 2020
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Description
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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
Diabetic Macular Edema Drug: LKA651 Drug: Lucentis Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated 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 : January 23, 2019
Estimated Primary Completion Date : November 2, 2021
Estimated Study Completion Date : November 2, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema
Drug Information available for: Ranibizumab

Arms and Interventions
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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
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Primary Outcome Measures :
  1. Adverse event profile and safety endpoints of LKA651 [ Time Frame: Day 169 ]
    Incidence of treatment emergent adverse events and study drug related adverse events.

  2. Effect of LKA651 on Best Corrected Visual Acuity (BCVA) [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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
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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03927690


Contacts
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Contact: Novartis Pharmaceuticals 1-888-669-6682 Novartis.email@novartis.com
Contact: Novartis Pharmaceuticals +41613241111

Locations
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United States, California
Novartis Investigative Site Recruiting
Beverly Hills, California, United States, 90211
Novartis Investigative Site Recruiting
Rancho Cordova, California, United States, 95670
United States, Florida
Novartis Investigative Site Recruiting
Miami, Florida, United States, 33143
United States, Nevada
Novartis Investigative Site Recruiting
Reno, Nevada, United States, 89502
United States, South Dakota
Novartis Investigative Site Recruiting
Rapid City, South Dakota, United States, 57701
United States, Texas
Novartis Investigative Site Recruiting
Austin, Texas, United States, 78793
Novartis Investigative Site Recruiting
Houston, Texas, United States, 77025
Novartis Investigative Site Recruiting
San Antonio, Texas, United States, 78240
Germany
Novartis Investigative Site Recruiting
Berlin, Germany, 13353
Novartis Investigative Site Recruiting
Gottingen, Germany, 37075
Novartis Investigative Site Recruiting
Hannover, Germany, 30625
Novartis Investigative Site Recruiting
Muenster, Germany, 48145
Novartis Investigative Site Recruiting
Tuebingen, Germany, 72076
Puerto Rico
Novartis Investigative Site Recruiting
Arecibo, Puerto Rico, 00612
Spain
Novartis Investigative Site Recruiting
Sevilla, Andalucia, Spain, 41009
Novartis Investigative Site Recruiting
Barcelona, Catalunya, Spain, 08036
Novartis Investigative Site Recruiting
Sant Cugat, Catalunya, Spain, 08190
Novartis Investigative Site Recruiting
Barcelona, Cataluña, Spain, 08025
Novartis Investigative Site Recruiting
Zaragoza, Spain, 50009
Sponsors and Collaborators
Novartis Pharmaceuticals
More Information
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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03927690    
Other Study ID Numbers: CLKA651X2202
First Posted: April 25, 2019    Key Record Dates
Last Update Posted: November 2, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Macular Edema
Edema
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Ranibizumab
 Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents