Use of Pan-Vascular Endothelial Growth Factor Receptor (Pan-VEGF) Blockade for the Treatment of Retinopathy of Prematurity (ROP) (Compassionate Use BLOCK-ROP)

• Status: Temporarily not available
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to provide access to intravitreal injection of Avastin in high-risk infants who do not otherwise qualify for study NCT00702819, an investigational multi-site study examining Avastin use for retinopathy of prematurity.

Details

• Lead Sponsor: Children's Hospital Los Angeles
• Treatments: Bevacizumab; Endothelial Growth Factors; Mitogens

Criteria

Inclusion Criteria:

• Inborn babies at CHLA NICU

• Outborn babies transferred to CHLA NICU

• Zone 1 or 2 ROP

• Adequate/appropriate laser ablation

• Failed standard laser treatment (persistent Plus disease at a minimum of 1 week post-laser)

• Post-menstrual age greater than 30 weeks

Exclusion Criteria:

• Zone 3 ROP

• Inadequate initial laser treatment

• Most recent laser treatment less than 1 week

• Evidence of tractional retinal detachment (exudative retinal detachment may be included in study group)

• Post-menstrual age less than 30 weeks

• Health not allowing for full protocol participation (determined by neonatologist)