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

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000041382
Enrollment
100
Registered
2020-08-11
Start date
2020-08-12
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

wet age-related macular degeneration

Interventions

Intravitreous injection of Beovu(Brolucizumab) for 2 years when needed.

Sponsors

kagawa university
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 3)disease duration:regardless 4)Patients who existing anti-VEGF drugs (aflibercept or ranibizumabu) are used, and vitreous injections are performed every 1-3months in the maintenance phase, and exudation dose not improve for 1 year or more(tolerance), who progress vision loss, who relapses immediately without without injection (dependency), and who do not respond to existing anti-VEGF drug therapy from the initial treatment (non responder). 5)BCVA:0.1-1.0 6)Presence of subretinal hemorrhage, scar or macular fibrosis (<50% lesion area) 7)Patient consent:patients who, after receiving a sufficient explanation before participating in this study, obtained their informed consent by themselves. 8)Outpatien

Exclusion criteria

Exclusion 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

Design outcomes

Primary

MeasureTime frame
Improvement rate of visual acuity one year after the change of brolucizumab.

Secondary

MeasureTime frame
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

Countries

Japan

Contacts

Public ContactHirokazu Kojima

Kagawa Medical University Hospital ophthalmology

hkojima721@med.kagawa-u.ac.jp087-898-5111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026