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

Korábbi kezelés

• Previous treatment with any approved or investigational drugs for nAMD in the study eye (other than vitamin supplements).
• Current vitreous hemorrhage or history of vitreous hemorrhage in the study eye within 4 weeks prior to baseline.

Más betegség

• 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.

Egyéb

• 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.
• Retinal pigment epithelium rip/tear in the study eye at screening.

• 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.