Summary

for people ages 18 years and up (full criteria)
at Sacramento, California and other locations
study started
estimated completion

Description

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.

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)

Details

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.

Keywords

Diabetic Macular Edema intravitreal injection brolucizumab aflibercept double-masked Vision Disorders Vision, Low Macular Edema Edema Brolucizumab 6mg q4w Aflibercept 2mg q4w

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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)

You CAN'T join if...

  • 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

Locations

  • Novartis Investigative Site accepting new patients
    Sacramento California 95841 United States
  • Novartis Investigative Site accepting new patients
    Rancho Cordova California 95670 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Novartis Pharmaceuticals
Links
Sign up for this study
ID
NCT03917472
Phase
Phase 3
Study Type
Interventional
Last Updated