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)
All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation.
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.
Diabetic Macular Edema
Active, not recruiting
Jun 11, 2020
Jul 17, 2019
Aug 13, 2021
18 Years and older (Adult, Older Adult)
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)
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