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

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ClinicalTrials.gov Identifier: NCT03917472
Recruitment Status : Not yet recruiting
First Posted : April 17, 2019
Last Update Posted : April 17, 2019
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

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.

Condition or disease Intervention/treatment Phase
Diabetic Macular Edema Drug: Brolucizumab Drug: Aflibercept Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
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
Official Title: 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)
Estimated Study Start Date : July 31, 2019
Estimated Primary Completion Date : July 30, 2021
Estimated Study Completion Date : July 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema

Arm Intervention/treatment
Experimental: Brolucizumab 6mg q4w
Brolucizumab 6 mg/0.05 mL every 4 weeks.
Drug: Brolucizumab
Intravitreal injection
Other Name: RTH258, ESBA1008

Active Comparator: Aflibercept 2mg q4w
Aflibercept 2mg/0.05 mL every 4 weeks
Drug: Aflibercept
Intravitreal injection
Other Name: Eylea




Primary Outcome Measures :
  1. Change in best-corrected visual acuity (BCVA) from baseline up to Week 52 [ Time Frame: Week 52 ]
    Assessed with ETDRS visual acuity testing charts


Secondary Outcome Measures :
  1. Change from baseline in central subfield thickness (CSFT) at each post-baseline visit [ Time Frame: Baseline up to Week 52 ]
    Assessed by SD-OCT

  2. Proportion of study eyes with fluid-free macula at each post-baseline visit [ Time Frame: Baseline up to Week 52 ]
    Assessed by SD-OCT

  3. 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

  4. Time to first fluid-free macula [ Time Frame: Baseline up to Week 52 ]
    Assessed by SD-OCT

  5. 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

  6. Change from baseline in BCVA at each post-baseline visit [ Time Frame: Baseline up to Week 52 ]
    Assessed with ETDRS visual acuity testing charts

  7. 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

  8. 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

  9. Percentage of Participants according to Anti-Drug Antibody (ADA) status for brolucizumab [ Time Frame: Baseline up to Week 52 ]
    Blood draw



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT03917472


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

Sponsors and Collaborators
Novartis Pharmaceuticals

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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03917472     History of Changes
Other Study ID Numbers: CRTH258B2305
2019-001004-37 ( EudraCT Number )
First Posted: April 17, 2019    Key Record Dates
Last Update Posted: April 17, 2019
Last Verified: April 2019
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 elegible 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


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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Diabetic Macular Edema
intravitreal injection
brolucizumab
aflibercept
double-masked

Additional relevant MeSH terms:
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Edema
Macular Edema
Vision Disorders
Vision, Low
Signs and Symptoms
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases