Post-marketing Surveillance Protocol Number; CRTH258B1401

Special drug use observational study with Beovu kit for intravitreal injection (DME, CRTH258B1401)

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-jRCT2031220323

Enrollment

200

Registered

2022-09-08

Start date

2022-09-01

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

diabetic macular edema (DME)

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients must provide written consent to cooperate in this study before the start of treatment with Beovu 2. Patients using Beovu for the first time for the following indication - Indication: diabetic macular edema

Exclusion criteria

Exclusion criteria: Patients with a history of treatment with a drug containing the same ingredient (brolucizumab) as Beovu

Design outcomes

Primary

Measure	Time frame
1. Numbers and proportions of patients with adverse events corresponding to each of the safety specifications during the observation period 2. Numbers and proportions of patients with adverse events in the eyes on therapy during the observation period 3. Numbers and proportions of patients with systemic (non-ocular) adverse events during the observation period *:Safety specifications: intraocular inflammation, endophthalmitis, intraocular pressure elevation, retinal detachment and retinal tear, retinal arterialembolic events, non-ocular arterial thromboembolic events, retinal vasculitis and retinal vascular occlusion	—

Measure

Time frame

1. Numbers and proportions of patients with adverse events corresponding to each of the safety specifications during the observation period 2. Numbers and proportions of patients with adverse events in the eyes on therapy during the observation period 3. Numbers and proportions of patients with systemic (non-ocular) adverse events during the observation period *:Safety specifications: intraocular inflammation, endophthalmitis, intraocular pressure elevation, retinal detachment and retinal tear, retinal arterialembolic events, non-ocular arterial thromboembolic events, retinal vasculitis and retinal vascular occlusion

—

Contacts

Public ContactNovartis Direct

Novartis Pharma. K.K.

sm.pms@novartis.com+81-120003293

Outcome results