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

Completed · Phase 3

Conditions studied: Diabetic Macular Edema

In brief

The purpose of this study was to evaluate the efficacy and safety of brolucizumab vs. aflibercept in the treatment of patients with visual impairment due to diabetic macular edema (DME).

Key facts

Study ID

NCT03917472

Run by

Novartis Pharmaceuticals

People needed

517

Starts

2019-07-17

Expected to finish

2021-03-24

Last updated by the study team

2022-08-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 may not qualify 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

Where it is running

• Novartis Investigative Site — Phoenix, Arizona, United States
• Novartis Investigative Site — Tucson, Arizona, United States
• Novartis Investigative Site — Beverly Hills, California, United States
• Novartis Investigative Site — Campbell, California, United States
• Novartis Investigative Site — Fresno, California, United States
• Novartis Investigative Site — Huntington Beach, California, United States
• Novartis Investigative Site — Loma Linda, California, United States
• Novartis Investigative Site — Mountain View, California, United States
• Novartis Investigative Site — Oakland, California, United States
• Novartis Investigative Site — Pasadena, California, United States
• Novartis Investigative Site — Poway, California, United States
• Novartis Investigative Site — Rancho Cordova, California, United States
• Novartis Investigative Site — Redlands, California, United States
• Novartis Investigative Site — Riverside, California, United States
• Novartis Investigative Site — Sacramento, California, United States
• Novartis Investigative Site — Sacramento, California, United States
• Novartis Investigative Site — San Francisco, California, United States
• Novartis Investigative Site — Santa Ana, California, United States
• Novartis Investigative Site — Santa Barbara, California, United States
• Novartis Investigative Site — Torrance, California, United States
• Novartis Investigative Site — Ventura, California, United States
• Novartis Investigative Site — Altamonte Springs, Florida, United States
• Novartis Investigative Site — Deerfield Beach, Florida, United States
• Novartis Investigative Site — Fort Lauderdale, Florida, United States
• Novartis Investigative Site — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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