Efficacy of anti-VEGF drug on retinopathy of prematurity

JRCT ID: jRCTs051210204

Registered date:01/04/2022

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Retinopathy of prematurity
• Date of first enrollment: 01/04/2022
• Target sample size: 34
• Study type: Interventional
• Intervention(s): Vitreous injection of anti-VEGF drugs (bevacizumab or ranibizumab)

Outcome(s)

• Primary Outcome: 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

Efficacy endpoints
1)Duration from protocol treatment to additional treatment of the treated eye
2)Percentage of additional laser treatment required for each treated eye at 4, 10, and 24 weeks after protocol treatment
3)Percentage of treated eyes requiring additional Ranibizumab or laser therapy by 4, 10, and 24 weeks after the protocol treatment.
4)Percentage of patients who required additional laser treatment in both eyes by 4, 10, and 24 weeks after the protocol treatment.
5)Percentage of patients requiring additional ranibizumab or laser therapy in both eyes by 4, 10, and 24 weeks after the protocol treatment.
Safety endpoints
1)Proportion of disease during the observation period
2)Percentage of endophthalmitis
3)Percentage of lens damage
4)Percentage of retinal detachment and fundus hemorrhage due to needle puncture
5)Percentage of onset or worsening of respiratory failure
6)Percentage of asphyxiation
7)Percentage of myocardial infarction
8)Percentage of other cardiovascular disorders that occurred or worsened.
Exploratory endpoints
1)In children who received a second vitreous injection at 4 weeks after ranibizumab treatment, whether or not additional laser treatment was required at 10 weeks after the initial treatment.
2)VEGF concentration in blood

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: Not applicable
• Gender: Both

Include 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.

Exclude 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

Related Information

• Primary Sponsor: Ueda Kaori