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

ClinicalTrials.gov Identifier: NCT04047472

Novartis Reference Number: CRTH258A2307

Last Update: Jan 23, 2023

All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation.

Study Description

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

Condition

Neovascular Age-Related Macular Degeneration

Phase

Phase 3

Overall status

Recruiting

Start date

Nov 29, 2019

Completion date

Apr 25, 2024

Gender

All

Age(s)

50 Years and older (Adult, Older Adult)

Interventions

Drug

Brolucizumab 6mg

Subjects will receive Brolucizumab 3 x q4w up to Week 8 followed by q12w / q8w up to Week 40 or Week 44, depending on disease activity status.

Drug

Aflibercept 2 mg

Subjects will receive Aflibercept 3 x q4w up to Week 8 followed by q8w up to Week 40.

Eligibility Criteria

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.