A 2-year study comparing the efficacy and safety of anti-VEGF drugs (aflibercept and brolucizumab) in patients with exudative age-related macular degeneration.

UMIN ID: UMIN000041389

Registered date:12/08/2020

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: wet age-related macular degeneration
• Date of first enrollment: 2020/07/20
• Target sample size: 140
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Eylea (aflibercept)
Beovu(brolucizmab)

Outcome(s)

• Primary Outcome: Amount of change in visual acuity at 52 weeks
• Secondary Outcome: The average treatment number according to the medicine , central macular thickness, change of leakage in retinal region, leakage from a polyp, leakage from choroidal neovascularization, subretinal fluid , the rate of incident and the enlargement of the geographic atrophy

Key inclusion & exclusion criteria

• Age minimum: 45years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: 1) Greatest Linear Dimension (GLD) of the total lesion area <12 Macular Photocoagulation Study Disc Areas 2) Presence of subretinal hemorrhage, scar or macular fibrosis (>50% lesion area) 3) Prior treatment with anti-VEGF drug, photodynamic therapy 4) Prior treatment with dexamethasone (<6 months) or triamcinolone (<30 days), intraocular surgery (<3 months) 5) Active intraocular inflammation 6) Hypersensitivity or allergy to fluorescein or indocyanine green, clinically significant drug allergy or known hypersensitivity to therapeutic or diagnostic protein products 7) Patient who the doctor in charge judges are ineligible for the study

Related Information

• Primary Sponsor: kagawa univercity
• Source(s) of Monetary Support: nothing