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

Novartis

Status and phase: Completed; Phase 3

Conditions: Neovascular Age-Related Macular Degeneration

Treatments: Drug: Aflibercept 2 mg; Drug: Brolucizumab 6mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT04047472

CRTH258A2307

Details and patient eligibility

About

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

Full 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, participants were randomized in a 1:1 ratio to one of the 2 treatment arms:

• Brolucizumab 6 mg: 3 monthly intravitreal injections of brolucizumab 6 mg in the loading treatment period (q4w regimen) up to Week 8 followed by injections every 12 weeks (q12w regimen) or 8 weeks (q8w) up to Week 40 or Week 44, depending on disease activity status.
• Aflibercept 2 mg: 3 monthly intravitreal injections of aflibercept 2 mg in the loading treatment period (q4w regimen) up to Week 8 followed by injections every 8 weeks (q8w) up to Week 40. Disease activity assessments (DAAs) were conducted by the masked investigator for both treatment arms at Weeks 16, 20, 32 and 44 to determine the regimen of brolucizumab arm (i.e., q12w or q8w).

Enrollment: 397 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 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 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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397 participants in 2 patient groups

Brolucizumab 6 mg

Experimental group

Description:

3 monthly intravitreal injections of brolucizumab 6 mg in the loading treatment period (q4w regimen) up to Week 8 followed by injections every 12 weeks (q12w regimen) or 8 weeks (q8w) up to Week 40 or Week 44, depending on disease activity status.

Treatment:

Drug: Brolucizumab 6mg

Aflibercept 2 mg

Active Comparator group

Description:

3 monthly intravitreal injections of aflibercept 2 mg in the loading treatment period (q4w regimen) up to Week 8 followed by injections every 8 weeks (q8w) up to Week 40.

Treatment:

Drug: Aflibercept 2 mg