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

NCT00870636 | Unknown

• 1 other identifier: CCI-09-00044
• Study Type: expanded_access
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Retinopathy of Prematurity

Keywords

Pan-Vascular Endothelial Growth Factor Blockade; Safety; ROP; Bevacizumab; Avastin

Interventions

Bevacizumab (Avastin) DRUG

Dosage of 0.75mg/0.03ml intravitreal injectable, one time only.

Also known as: Avastin

Eligibility Criteria

• Age: 30 Weeks+
• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Children's Hospital Los Angeles: lead

Study Sites (1)

Childrens Hospital Los Angeles

Los Angeles, California, 90027, United States

Location

MeSH Terms

Conditions

Retinopathy of Prematurity

Interventions

Bevacizumab

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Thomas Lee, M.D.

  Children's Hospital Los Angeles

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: expanded access
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Ophthalmology Keck School of Medicine

Study Record Dates

• First Submitted: March 26, 2009
• First Posted: March 27, 2009
• Last Updated: November 24, 2023

Record last verified: 2023-11

Locations

US (1)