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

• Status: Recruiting
• Trial end date: 2023-06-26
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Aflibercept

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.