Efficacy of anti-VEGF drug on retinopathy of prematurity
Phase 2
Recruiting
- Conditions
- Retinopathy of prematurityretinopathy of prematurity
- Registration Number
- JPRN-jRCTs051210204
- Lead Sponsor
- eda Kaori
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 34
Inclusion Criteria
(1) Infants who are judged to require therapeutic intervention as severe retinopathy of prematurity based on the ETROP study.
1.zoneI, any stage ROP with plus disease
2.zoneII, stage3 ROP without plus disease
3.zoneII, stage2 or 3 ROP with plus disease
4.APROP
(2) Infants who have obtained consent from their parents to participate in the study for both eyes.
Exclusion Criteria
(1) Infants who are in poor general condition and cannot undergo ophthalmologic examination
(2) Infants with eye infections
(3) Infants who are judged to be best treated with laser therapy at the time of initial treatment
(4) Infants who are judged to be inappropriate for participation in clinical research
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The percentage of eyes with fundus findings requiring additional ranibizumab or laser therapy as determined by a third party by week 24 after protocol treatment in each treated eye.
- Secondary Outcome Measures
Name Time Method