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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/20/2021.

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

Clinicaltrials.gov identifier NCT03927690

Recruitment Status Recruiting

First Posted April 25, 2019

Last update posted March 16, 2020

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:Diabetic Macular Edema
  • Intervention/Treatment: Drug: LKA651
    Drug: Lucentis
    Drug: Lucentis
    Drug: LKA651
  • Phase: Phase 2
Detailed Description

N/A

Study Design
  • Study Type: Interventional
  • 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 2019
  • Estimated Primary Completion Date: February 2021
  • Estimated Study Completion Date: February 2021
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
  • Ages Eligible for Study: 18 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

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

Contact: Novartis Pharmaceuticals +41613241111

Locations
Show 18 Study Locations
Sponsors and Collaborators

Novartis Pharmaceuticals

More Information
  • Responsible Party: Novartis Pharmaceuticals
  • ClinicalTrials.gov Identifier: NCT03927690 History of Changes
  • Other Study ID Numbers: CLKA651X2202
  • First Posted: April 25, 2019 Key Record Dates
  • Last Update Posted: March 16, 2020
  • Last Verified: March 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
  • Studies a U.S. FDA-regulated Drug Product: Yes
  • Studies a U.S. FDA-regulated Device Product: No
  • Additional relevant MeSH terms: Macular Edema Edema