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出境医 / 临床实验 / Multiple Dose Safety and Efficacy of LKA651 in Patients With Diabetic Macular Edema

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

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
Diabetic Macular Edema Drug: LKA651 Drug: Lucentis Phase 2

Study Design
Layout table for study information
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 : December 22, 2022
Estimated Study Completion Date : December 22, 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 [ 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

Contacts
Layout table for location contacts
Contact: Novartis Pharmaceuticals 1-888-669-6682 Novartis.email@novartis.com
Contact: Novartis Pharmaceuticals +41613241111

Locations
Layout table for location information
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
Novartis Investigative Site Recruiting
Winter Haven, Florida, United States, 33880
United States, Hawaii
Novartis Investigative Site Recruiting
'Aiea, Hawaii, United States, 96701
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
Duesseldorf, Germany, 40212
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
Turkey
Novartis Investigative Site Recruiting
Ankara, Turkey, 06100
Novartis Investigative Site Recruiting
Ankara, Turkey, 06490
Novartis Investigative Site Recruiting
Ankara, Turkey, 06500
Novartis Investigative Site Recruiting
Kocaeli, Turkey, 41380
Sponsors and Collaborators
Novartis Pharmaceuticals
Tracking Information
First Submitted Date  ICMJE April 23, 2019
First Posted Date  ICMJE April 25, 2019
Last Update Posted Date May 17, 2021
Actual Study Start Date  ICMJE January 23, 2019
Estimated Primary Completion Date December 22, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 23, 2019)
  • Adverse event profile and safety endpoints of LKA651 [ Time Frame: Day 169 ]
    Incidence of treatment emergent adverse events and study drug related adverse events.
  • 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
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 23, 2019)
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Multiple Dose Safety and Efficacy of LKA651 in Patients With Diabetic Macular Edema
Official Title  ICMJE A Randomized, Active-controlled, Patient and Investigator-masked, Multiple Dose Proof-of-concept Study of Intravitreal LKA651 in Patients With Diabetic Macular Edema
Brief Summary To evaluate the safety and efficacy of LKA651 in patients with macular edema from diabetic macular edema (DME),
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Diabetic Macular Edema
Intervention  ICMJE
  • Drug: LKA651
    LKA651 IVT
  • Drug: Lucentis
    Lucentis IVT
Study Arms  ICMJE
  • Experimental: LKA651
    LKA651 IVT
    Intervention: Drug: LKA651
  • Experimental: LKA651/Lucentis
    LKA651/Lucentis IVT
    Interventions:
    • Drug: LKA651
    • Drug: Lucentis
  • Active Comparator: Lucentis
    Lucentis IVT
    Intervention: Drug: Lucentis
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 23, 2019) 		90
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 22, 2022
Estimated Primary Completion Date December 22, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Novartis Pharmaceuticals 1-888-669-6682 Novartis.email@novartis.com
Contact: Novartis Pharmaceuticals +41613241111
Listed Location Countries  ICMJE Germany,   Puerto Rico,   Spain,   Turkey,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03927690
Other Study ID Numbers  ICMJE CLKA651X2202
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
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
Responsible Party Novartis ( Novartis Pharmaceuticals )
Study Sponsor  ICMJE Novartis Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Novartis
Verification Date May 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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