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NCT04047472CompletedPhase 3

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

A Twelve-Month, Randomized, Double-Masked, Multicenter, Phase III, Two-Arm Study Comparing the Efficacy and Safety of Brolucizumab 6 mg Versus Aflibercept in Chinese Patients With Neovascular Age-Related Macular Degeneration

Source: ClinicalTrials.gov · Last updated 9 Dec 2024

Brief summary (registry, in English)

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

Status (registry)
Completed
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
397 (actual)
First submitted
1 Jul 2019
Start date
29 Nov 2019
Primary completion date
28 Feb 2024
Lead sponsor
Novartis Pharmaceuticals
NCT number
NCT04047472

What you commit to

  • Study type: Interventional · Phase 3
  • Participants enrolled: 397
  • From 29 Nov 2019 to the primary completion date, 28 Feb 2024
  • 17 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Previous treatment with any approved or investigational drugs for nAMD in the study eye (other than vitamin supplements).
  • Current vitreous hemorrhage or history of vitreous hemorrhage in the study eye within 4 weeks prior to baseline.

Other illness

  • 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.

Other

  • Central subfield of the study eye affected by fibrosis or geographic atrophy assessed by color fundus photography at screening and confirmed by the CRC.
  • Total area of fibrosis ≥ 50% of the total lesion in the study eye at screening and confirmed by the CRC.
  • Subretinal blood affecting the foveal center point and/or ≥ 50% of the lesion of the study eye at screening and confirmed by the CRC.
  • Retinal pigment epithelium rip/tear in the study eye at screening.

Who the study is looking for

  • Written informed consent must be obtained before any assessment was performed.
  • Male or female Chinese participants ≥ 50 years of age at the time of screening.
  • Active CNV lesions secondary to AMD that affect the central subfield (including retinal angiomatous proliferation lesions with a CNV component) in the study eye at screening and confirmed by the Central Reading Center (CRC).
  • Total area of CNV (including both classic and occult components) must comprise \> 50% of the total lesion area in the study eye at screening and confirmed by the CRC.
  • Intra and/or subretinal fluid affecting the central subfield of the study eye at screening and confirmed by the CRC.
  • BCVA between 78 and 23 letters, inclusive, in the study eye at screening and baseline using ETDRS testing.

Age in the registry: 50 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (17)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Novartis Investigative Site
Coordinator of this site? Confirm its status
BeijingChinaUnknown status
Novartis Investigative Site
Coordinator of this site? Confirm its status
ChangchunChinaUnknown status
Novartis Investigative Site
Coordinator of this site? Confirm its status
ChongqingChinaUnknown status
Novartis Investigative Site
Coordinator of this site? Confirm its status
GuangzhouChinaUnknown status
Novartis Investigative Site
Coordinator of this site? Confirm its status
HangzhouChinaUnknown status
Novartis Investigative Site
Coordinator of this site? Confirm its status
HarbinChinaUnknown status
Novartis Investigative Site
Coordinator of this site? Confirm its status
JinanChinaUnknown status
Novartis Investigative Site
Coordinator of this site? Confirm its status
NanjingChinaUnknown status
Novartis Investigative Site
Coordinator of this site? Confirm its status
NantongChinaUnknown status
Novartis Investigative Site
Coordinator of this site? Confirm its status
ShanghaiChinaUnknown status
Novartis Investigative Site
Coordinator of this site? Confirm its status
ShantouChinaUnknown status
Novartis Investigative Site
Coordinator of this site? Confirm its status
ShenyangChinaUnknown status
Novartis Investigative Site
Coordinator of this site? Confirm its status
TaiyuanChinaUnknown status
Novartis Investigative Site
Coordinator of this site? Confirm its status
TianjinChinaUnknown status
Novartis Investigative Site
Coordinator of this site? Confirm its status
WuhanChinaUnknown status
Novartis Investigative Site
Coordinator of this site? Confirm its status
Xi’anChinaUnknown status
Novartis Investigative Site
Coordinator of this site? Confirm its status
YixingChinaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.