Status:
COMPLETED
Study of Efficacy and Safety of Brolucizumab vs. Aflibercept in Chinese Patients With Neovascular Age-Related Macular Degeneration
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Neovascular Age-Related Macular Degeneration
Eligibility:
All Genders
50+ years
Phase:
PHASE3
Brief Summary
To compare brolucizumab to aflibercept in Chinese patients with untreated active choroidal neovascularization (CNV) secondary to age-related macular degeneration (AMD)
Detailed Description
This was a randomized, double-masked, multicenter, parallel-group, active-controlled study. The study included 14 scheduled visits over 48 weeks. After confirmation of eligibility at baseline, partici...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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 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.
- Previous treatment with any approved or investigational drugs for nAMD in the study eye (other than vitamin supplements).
- Retinal pigment epithelium rip/tear in the study eye at screening.
- Current vitreous hemorrhage or history of vitreous hemorrhage in the study eye within 4 weeks prior to baseline.
Key Trial Info
Start Date :
November 29 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 28 2024
Estimated Enrollment :
397 Patients enrolled
Trial Details
Trial ID
NCT04047472
Start Date
November 29 2019
End Date
February 28 2024
Last Update
December 9 2024
Active Locations (30)
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1
Novartis Investigative Site
Beijing, Beijing Municipality, China, 100044
2
Novartis Investigative Site
Guangzhou, Guangdong, China, 410015
3
Novartis Investigative Site
Guangzhou, Guangdong, China, 510060
4
Novartis Investigative Site
Shantou, Guangdong, China, 515041