VABYSMO solution for intravitreal injection 120mg/mL, General drug use-results survey - Subfoveal choroidal neovascularization secondary to age-related macular degeneration, Diabetic macular edema -

VABYSMO solution for intravitreal injection 120mg/mL, General drug use-results survey - Subfoveal choroidal neovascularization secondary to age-related macular degeneration, Diabetic macular edema - - VABYSMO solution for intravitreal injection 120mg/mL, General drug use-results survey - Subfoveal choroidal neovascularization secondary to age-related macular degeneration, Diabetic macular edema -

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000047686

Enrollment

1660

Registered

2022-05-25

Start date

2022-05-25

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

Subfoveal choroidal neovascularization secondary to age-related macular degeneration (nAMD), Diabetic macular edema (DME)

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Target cases for enrollment: Patients with subfoveal choroidal neovascularization secondary to age-related macular degeneration or diabetic macular edema to whom VABYSMO is scheduled to be administered for the first time during the enrollment period in facilities where a contract for this surveillance has been concluded. Target cases for case report form collection: All patients from among the target cases for enrollment who use VABYSMO.

Exclusion criteria

Exclusion criteria: None

Design outcomes

Primary

Measure	Time frame
Main survey items etc. 1)Information on facilities: Name of facility, name of department, name of physician who fills out the case report form. 2)Patient demographics: Patient initials, sex, pregnancy status, age at administration start, medical category (outpatient / inpatient), identification number, reason for use, height, weight, blood pressure (systolic / diastolic), smoking, disease duration, allergic history, previous medical history, complications. (The below, only nAMD) Exudative nAMD type. (The below, only DME) Classification of diabetes mellitus, disease duration of diabetes mellitus, HbA1c of the start of administration, diabetic macular edema type, the type of diabetic retinopathy. 3)Prior treatment history: Name of prior treatment, treatment area, reason for discontinuation. 4)Administration status of VABYSMO: Amount in a single dose, administration eye, administration date, status of VABYSMO at the end of the observation period. 5)Concomitant drugs: Name of drug, treatment area, the start date of administration, the terminated date of administration. 6)Combination therapy: Name of therapy, treatment area, treatment date. 7)If adverse events occur: Name of adverse event or laboratory test values abnormality, date of onset, onset area, severity, treatment (VABYSMO, other), outcome, date of outcome, causal relationship (VABYSMO, other cause). 8)Visual acuity: Decimal visual acuity (only VABYSMO administration eye), (at the start of administration, at 16 weeks after the start of administration, at 64 weeks after the start of administration, at the terminated date of administration). 9)Central subfield thickness: Central subfield thickness (only VABYSMO administration eye), (at the start of administration, at 16 weeks after the start of administration, at 64 weeks after the start of administration, at the terminated date of administration).	—

Measure

Time frame

Main survey items etc. 1)Information on facilities: Name of facility, name of department, name of physician who fills out the case report form. 2)Patient demographics: Patient initials, sex, pregnancy status, age at administration start, medical category (outpatient / inpatient), identification number, reason for use, height, weight, blood pressure (systolic / diastolic), smoking, disease duration, allergic history, previous medical history, complications. (The below, only nAMD) Exudative nAMD type. (The below, only DME) Classification of diabetes mellitus, disease duration of diabetes mellitus, HbA1c of the start of administration, diabetic macular edema type, the type of diabetic retinopathy. 3)Prior treatment history: Name of prior treatment, treatment area, reason for discontinuation. 4)Administration status of VABYSMO: Amount in a single dose, administration eye, administration date, status of VABYSMO at the end of the observation period. 5)Concomitant drugs: Name of drug, treatment area, the start date of administration, the terminated date of administration. 6)Combination therapy: Name of therapy, treatment area, treatment date. 7)If adverse events occur: Name of adverse event or laboratory test values abnormality, date of onset, onset area, severity, treatment (VABYSMO, other), outcome, date of outcome, causal relationship (VABYSMO, other cause). 8)Visual acuity: Decimal visual acuity (only VABYSMO administration eye), (at the start of administration, at 16 weeks after the start of administration, at 64 weeks after the start of administration, at the terminated date of administration). 9)Central subfield thickness: Central subfield thickness (only VABYSMO administration eye), (at the start of administration, at 16 weeks after the start of administration, at 64 weeks after the start of administration, at the terminated date of administration).

—

Countries

Japan

Contacts

Public ContactMurayama Ayako

Chugai Pharmaceutical Co. Ltd. Safety Science 2 Dept.

murayamaayk@chugai-pharm.co.jp03-3281-6611

Outcome results