Study of Efficacy and Safety of Brolucizumab vs. Aflibercept in Chinese Patients With Neovascular Age-Related Macular Degeneration

  • STATUS
    Recruiting
  • End date
    Jun 26, 2023
  • participants needed
    494
  • sponsor
    Novartis Pharmaceuticals
Updated on 8 December 2021
neovascularization
aflibercept
age-related macular degeneration
brolucizumab

Summary

To compare brolucizumab to aflibercept in Chinese patients with untreated active choroidal neovascularization (CNV) secondary to age-related macular degeneration (AMD)

Details
Condition Neovascular Age-Related Macular Degeneration, Neovascular Age-Related Macular Degeneration, Neovascular Age-Related Macular Degeneration, Neovascular Age-Related Macular Degeneration, Neovascular Age-Related Macular Degeneration, Neovascular Age Related Macular Degeneration
Treatment Aflibercept 2 mg, Brolucizumab 6mg
Clinical Study IdentifierNCT04047472
SponsorNovartis Pharmaceuticals
Last Modified on8 December 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Written informed consent must be obtained before any assessment is performed
Active choroidal neovascularization (CNV) lesions secondary to AMD that affect the central subfield in the study eye
Total area of CNV>50% of the total lesion area in the study eye at screening

Exclusion Criteria

Any active intraocular or periocular infection or active intraocular inflammation (e.g. infectious conjunctivitis, keratitis, scleritis, endophthalmitis, infectious blepharitis, uveitis) in study eye at Baseline
Central subfield of the study eye affected by fibrosis or geographic atrophy
Uncontrolled glaucoma in the study eye defined as intraocular pressure (IOP) >25 mmHg
Previous treatment with any anti-VEGF drugs in the study eye
Previous treatment with any approved or investigational drugs for neovascular AMD in the study eye
Other protocol-specified inclusion or exclusion criteria may apply
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