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Efficacy and Safety of Brolucizumab vs Aflibercept in Patients With Visual Impairment Due to Diabetic Macular Edema (DME)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03917472
Recruitment Status : Active, not recruiting
First Posted : April 17, 2019
Last Update Posted : June 11, 2020
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Tracking Information
First Submitted Date  ICMJE April 11, 2019
First Posted Date  ICMJE April 17, 2019
Last Update Posted Date June 11, 2020
Actual Study Start Date  ICMJE July 17, 2019
Estimated Primary Completion Date July 30, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 15, 2019)
Change in best-corrected visual acuity (BCVA) from baseline up to Week 52 [ Time Frame: Week 52 ]
Assessed with ETDRS visual acuity testing charts
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 15, 2019)
  • Change from baseline in central subfield thickness (CSFT) at each post-baseline visit [ Time Frame: Baseline up to Week 52 ]
    Assessed by SD-OCT
  • Proportion of study eyes with fluid-free macula at each post-baseline visit [ Time Frame: Baseline up to Week 52 ]
    Assessed by SD-OCT
  • Proportion of study eyes with absence of DME (CSFT < 280 μm) at each post-baseline visit [ Time Frame: Baseline up to Week 52 ]
    Assessed by SD-OCT
  • Time to first fluid-free macula [ Time Frame: Baseline up to Week 52 ]
    Assessed by SD-OCT
  • Time to first absence of DME (CSFT < 280 μm) at each post-baseline visit [ Time Frame: Baseline up to Week 52 ]
    Assessed by SD-OCT
  • Change from baseline in BCVA at each post-baseline visit [ Time Frame: Baseline up to Week 52 ]
    Assessed with ETDRS visual acuity testing charts
  • Proportion of study eyes with gain in BCVA of 5/10/15 letters or more at each post-baseline visit compared to Baseline [ Time Frame: Baseline up to Week 52 ]
    Assessed with ETDRS visual acuity testing charts
  • Change from baseline in Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS) score [ Time Frame: Baseline uo to Week 52 ]
    Assessed by color fundus photography
  • Percentage of Participants according to Anti-Drug Antibody (ADA) status for brolucizumab [ Time Frame: Baseline up to Week 52 ]
    Blood draw
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 Efficacy and Safety of Brolucizumab vs Aflibercept in Patients With Visual Impairment Due to Diabetic Macular Edema
Official Title  ICMJE A 12-Month, 2-Arm, Randomized, Double-Masked, Multicenter Phase III Study Assessing the Efficacy and Safety of Brolucizumab vs. Aflibercept in Patients With Visual Impairment Due to Diabetic Macular Edema (KINGFISHER)
Brief Summary The purpose of this study is to evaluate the efficacy and safety of brolucizumab vs. aflibercept in the treatment of patients with visual impairment due to DME.
Detailed Description In this 12-month, randomized, double-masked,multicenter, active controlled study, consenting patients will be randomized in a 2:1 ratio (brolucizumab: aflibercept) and attend 15 planned visits.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description:
A masked evaluating investigator will be responsible for all aspects of the study except the injections and the safety assessment following the injections. An unmasked treating investigator will perform the injections and assess patient safety following the injections.
Primary Purpose: Treatment
Condition  ICMJE Diabetic Macular Edema
Intervention  ICMJE
  • Drug: Brolucizumab
    Intravitreal injection
    Other Name: RTH258, ESBA1008
  • Drug: Aflibercept
    Intravitreal injection
    Other Name: Eylea
Study Arms  ICMJE
  • Experimental: Brolucizumab 6mg q4w
    Brolucizumab 6 mg/0.05 mL every 4 weeks.
    Intervention: Drug: Brolucizumab
  • Active Comparator: Aflibercept 2mg q4w
    Aflibercept 2mg/0.05 mL every 4 weeks
    Intervention: Drug: Aflibercept
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 Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: June 9, 2020)
521
Original Estimated Enrollment  ICMJE
 (submitted: April 15, 2019)
500
Estimated Study Completion Date  ICMJE August 13, 2021
Estimated Primary Completion Date July 30, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Signed informed consent must be obtained prior to participation in the study.
  • Patients with type 1 or type 2 diabetes mellitus (DM) and Hemoglobin A1c (HbA1c) ≤ 12% at screening.
  • Study eye: Visual impairment due to DME with:

    • Best-corrected visual acuity (BCVA) score between 73 and 23 letters, inclusive, using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts at an initial testing distance of 4 meters
    • DME involving the center of the macula, with Central Subfield Thickness (CSFT) ≥ 320 µm on Spectral Domain Optical Coherence Tomography (SD-OCT)

Exclusion Criteria:

  • High-risk proliferative diabetic retinopathy (PDR) in the study eye
  • Concomitant conditions or ocular disorders in the study eye which confound interpretation of study results, compromise visual acuity or require medical or surgical intervention
  • Any active intraocular or periocular infection or active intraocular inflammation in the either eye
  • Uncontrolled glaucoma in the study eye
  • Presence of amblyopia, amaurosis or ocular disorders in the fellow eye with BCVA <20/200
  • Use of anti-VEGF therapies, intraocular surgery or laser photocoagulation (macular or panretinal) in the study eye during the 3-month period prior to baseline
  • Use of intraocular or periocular corticosteroids in the study eye during the 6-month period prior to baseline, and use of fluocinolone acetonide intravitreal (IVT) implant (Iluvien) at any time prior to baseline
  • Prior investigational drugs in either eye, vitreoretinal surgery in the study eye at any time prior to baseline
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Hungary,   Israel,   Puerto Rico,   Slovakia,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03917472
Other Study ID Numbers  ICMJE CRTH258B2305
2019-001004-37 ( EudraCT Number )
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 the patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to 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 June 2020

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