Pan-VEGF Blockade for the Treatment of Retinopathy of Prematurity (BLOCK-ROP)

• Status: Withdrawn
• Trial end date: 2018-07-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine whether a single intravitreal (into the gel of the eye) injection of Avastin 0.625mg or 0.75mg is equivalent (non-inferior) to treatment with standard of care laser in infants with Type I pre-threshold retinopathy of prematurity (ROP) diagnosed at 30-36 weeks gestational age.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Vision Research Foundation
• Treatments: Bevacizumab

Criteria

Inclusion Criteria:

• Inborn babies at participating NICU's who meet inclusion criteria

• Outborn babies transferred to participating NICU's who meet inclusion criteria

• Type 1 pre-threshold ROP

• No prior treatment

• Post menstrual age less than 36 1/7 weeks

• Post menstrual age greater than 30 weeks

Exclusion Criteria:

• Fatal systemic anomaly

• An ocular anomaly of one or both eye affecting the retina or choroid

• An ocular anomaly precluding use of the RetCam (ex., microphthalmia)

• Neonatologist feels inclusion will unduly challenge the infant

• Refusal of initial consent

• Refusal of subsequent evaluation

• Media opacity precluding fundus visualization (ex., cataract)

• Any ocular or periocular infection(s)