Examination of therapeutic efficacy after changing brolucizumab for patients with wet age-related macular degeneration using existing anti-VEGF drugs.

UMIN ID: UMIN000041382

Registered date:11/08/2020

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: wet age-related macular degeneration
• Date of first enrollment: 2020/08/12
• Target sample size: 100
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): Intravitreous injection of Beovu(Brolucizumab) for 2 years when needed.

Outcome(s)

• Primary Outcome: Improvement rate of visual acuity one year after the change of brolucizumab.
• Secondary Outcome: One year outcome after the change of brolcizumab:macula dry rate(presence of absence of exudative change), reduction rate of central macular thickness, change rate of subfoveal choroidal thickness, the rate of incidence and enlargement of macular atrophy, and number of administrations

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 dexamethasone (<6 months) or triamcinolone (<30 days), intraocular surgery (<3 months) 4) Active intraocular inflammation 5) Hypersensitivity or allergy to fluorescein or indocyanine green, clinically significant drug allergy or known hypersensitivity to therapeutic or diagnostic protein products 6) Patient who the doctor in charge judges are ineligible for the study

Related Information

• Primary Sponsor: kagawa university
• Source(s) of Monetary Support: Kagawa university