Bevacizumab therapy for retinopathy of prematurity

JRCT ID: jRCTs051180175

Registered date:26/03/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Intraocular neovascularization
• Date of first enrollment: 03/08/2016
• Target sample size: 30
• Study type: Interventional
• Intervention(s): Intravitreal bevacizumab injection

Outcome(s)

• Primary Outcome: Incidence of retinal detachment after treatment

Secondary Outcome

Incidence of cataract after treatment
Timing of retinal photocoagulation after treatment

Key inclusion & exclusion criteria

• Age minimum: 0 year-old
• Age maximum: 12 years-old
• Gender: Both

Include criteria

1, Patients with diseases in which intraocular neovascular vessels do not disappear or reappeared after conventional therapy such as retinal photocoagulation
2, Retinopathy of prematurity, regardless of treatment, is zone I disease, zone II disease with stage 2+ or 3+, and aggressive posterior retinopathy of prematurity in the international classification
3, From 2 weeks old to 12 years old
4, Written informed consent by parents

Exclude criteria

1, Patients with infarct disease, heart failure with poor control, hypertension, renal failure, abnormal blood coagulation ability, gastrointestinal ulcer
2, Patients who need to take other treatment priorities due to poor general condition
3. Patients who judged that neonatal specialists, pediatricians or the researcher are inappropriate as research subjects
4. Patients participating in other studies

Related Information

• Primary Sponsor: Ohnaka Masayuki