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
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.
To compare brolucizumab to aflibercept in Chinese patients with untreated active choroidal neovascularization (CNV) secondary to age-related macular degeneration (AMD)
Neovascular Age-Related Macular Degeneration
Nov 29, 2019
Apr 25, 2024
50 Years and older (Adult, Older Adult)
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.
Aflibercept 2 mg
Subjects will receive Aflibercept 3 x q4w up to Week 8 followed by q8w up to Week 40.
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
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.