To Compare Brolucizumab to Aflibercept in Chinese Patients With Visual Impairment Due to Diabetic Macular Edema

Last updated: October 7, 2024
Sponsor: Novartis Pharmaceuticals
Overall Status: Completed

Phase

3

Condition

Eye Disorders/infections

Diabetic Retinopathy

Diabetic Macular Edema

Treatment

Brolucizumab

Aflibercept

Clinical Study ID

NCT04058067
CRTH258B2304
  • Ages > 18
  • All Genders

Study Summary

The purpose of this study was to evaluate the efficacy and safety of brolucizumab in treatment of Chinese patients with visual impairment due to Diabetic Macular Edema.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Signed informed consent must be obtained prior to participation in the study.

  2. Patients ≥18 years of age at screening

  3. Patients with type 1 or type 2 diabetes mellitus (DM) and Hemoglobin A1c (HbA1c) of ≤10% at screening

  4. Medication for the management of diabetes must have been stable within 3 monthsprior to randomization and is expected to remain as stable as medically acceptableduring the course of the study

  5. Study Eye Visual impairment due to diabetic macular edema (DME) with:

  • Best-corrected visual acuity (BCVA) score between 78 and 23 letters, inclusive,using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity (VA)testing charts at a starting testing distance of 4 meters (approximate Snellenequivalent of 20/32 to 20/320) at screening and baseline

  • DME involving the center of the macula, with central subfield retinal thickness (e.g. measured from retinal pigment epithelium (RPE) to the inner limitingmembrane (ILM) inclusively) of ≥320 μm on Spectral domain optical coherencetomography (SD-OCT) at screening.

Exclusion

Exclusion Criteria:

  • Active Proliferative diabetic retinopathy (PDR) in the study eye as per investigator

  • Concomitant conditions or ocular disorders in the study eye at screening or baselinewhich could, in the opinion of the investigator, prevent response to study treatmentor may confound interpretation of study results, compromise visual acuity or requiremedical or surgical intervention for the duration of the study (e.g. cataract,vitreous hemorrhage, retinal vascular occlusion, retinal detachment, macular hole,or choroidal neovascularization (CNV) of any cause)

  • Any active intraocular or periocular infection or active intraocular inflammation (e.g. infectious conjunctivitis, keratitis, scleritis, endophthalmitis, infectiousblepharitis, uveitis) in study eye at screening or baseline

  • Structural damage of the fovea in the study eye at screening likely to precludeimprovement in visual acuity following the resolution of macular edema (ME),including atrophy of the retinal pigment epithelium, subretinal fibrosis, laserscar(s), epiretinal membrane involving fovea or organized hard exudate plaques

  • Uncontrolled glaucoma in the study eye defined as intraocular pressure (IOP) > 25mmHg on medication or according to investigator's judgment at Screening or Baseline

  • Neovascularization of the iris in the study eye at screening or baseline

  • Evidence of vitreomacular traction in the study eye at screening or baseline whichin the opinion of the investigator, affects visual acuity

  • Previous treatment with any anti-vascular growth factor (VEGF) drug orinvestigational drugs in the study eye

Study Design

Total Participants: 266
Treatment Group(s): 2
Primary Treatment: Brolucizumab
Phase: 3
Study Start date:
August 23, 2019
Estimated Completion Date:
January 31, 2023

Study Description

The study is a randomized, double-masked, multi-center, active-controlled, 2-arm study in Chinese patients with Diabetic macular edema (DME). Approximately 335 Chinese patients were planned to be screened (20% screening failure rate expected) and approximately 268 (134 per arm) patients were planned to be randomized in approximately 25 centers.

Patients who met all the inclusion and none of the exclusion criteria were randomized in a 1:1 ratio to one of two treatment arms:

  • Brolucizumab 6 mg: 5 × every 6 weeks (q6w) loading then every 12 weeks (q12w) or every 8 weeks (q8w) maintenance

  • Aflibercept 2 mg: 5 × every 4 weeks (q4w) loading then q8w maintenance

Disease activity assessments (DAAs) were conducted by the masked investigator for both treatment arms at Weeks 32, 36, and 48. In the brolucizumab arm, subjects who qualified for q12w during this initial q12w interval continued on a q12w treatment frequency unless disease activity was identified at the subsequent DAA visit at Week 48, in which case subjects were switched to a q8w treatment interval until Week 52.

Connect with a study center

  • Novartis Investigative Site

    Guangzhou, Guangdong 510060
    China

    Site Not Available

  • Novartis Investigative Site

    Shantou, Guangdong 515041
    China

    Site Not Available

  • Novartis Investigative Site

    Harbin, Heilongjiang 150001
    China

    Site Not Available

  • Novartis Investigative Site

    Wuhan, Hubei 430070
    China

    Site Not Available

  • Novartis Investigative Site

    Wuxi, Jiangsu 214002
    China

    Site Not Available

  • Novartis Investigative Site

    Changchun City, Jilin 130041
    China

    Site Not Available

  • Novartis Investigative Site

    Qingdao, Shandong 2666000
    China

    Site Not Available

  • Novartis Investigative Site

    Chengdu, Sichuan 610041
    China

    Site Not Available

  • Novartis Investigative Site

    Tianjin, Tianjin 300070
    China

    Site Not Available

  • Novartis Investigative Site

    Hangzhou, Zhejiang 310009
    China

    Site Not Available

  • Novartis Investigative Site

    Wenzhou, Zhejiang 325027
    China

    Site Not Available

  • Novartis Investigative Site

    Beijing, 100730
    China

    Site Not Available

  • Novartis Investigative Site

    Chongqing, 400042
    China

    Site Not Available

  • Novartis Investigative Site

    Nanjing, 210036
    China

    Site Not Available

  • Novartis Investigative Site

    Shanghai, 200031
    China

    Site Not Available

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