Bevacizumab Eliminates the Angiogenic Threat for Retinopathy of Prematurity

Status unconfirmed · Phase 2

Conditions studied: Retinopathy of Prematurity

In brief

The purpose of this study was to determine the efficacy and additional advantages of intravitreal bevacizumab in the treatment of ROP for both Zone I and Zone II Posterior.

Key facts

Study ID

NCT00622726

Run by

The University of Texas Health Science Center, Houston

People needed

150

Starts

2008-03-01

Expected to finish

2020-08-01

Last updated by the study team

2017-06-06

Who can join

Age: 0 and older, up to 0. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Infants who have been screened by the American Academy of Ophthalmology, the American Academy of Pediatrics, and the American Association for Pediatric Ophthalmology and Strabismus guidelines (≤1500 grams at birth and ≤30 weeks gestation) who develop Stage 3 ROP in zone I or posterior zone II.
• Informed Consent from a parent or guardian.

You may not qualify if…

• Infants who have a congenital systemic anomaly or have a congenital ocular abnormality.
• Infants who cannot be treated by conventional laser therapy because of problems with media clarity. Generally, blind external cryotherapy would be utilized as an initial therapy and the infant would be excluded from the study even if the media clear subsequently.
• Informed Consent from a parent or guardian refused. This will mean that an infant automatically will receive laser therapy. Bevacizumab (Avastin®) treatment cannot be given outside of the Protocol. No data will be used from an infant without Informed Consent.

Where it is running

• Huntington Memorial Hospital — Pasadena, California, United States
• Presbyterian-St. Luke's Hospital — Denver, Colorado, United States
• OSF St. Francis Medical Center-Children's Hospital of Illinois — Peoria, Illinois, United States
• Palmetto Health Richland Hospital — Columbia, South Carolina, United States
• Palmetto Health Baptist Hospital — Columbia, South Carolina, United States
• Driscoll Children's Hospital — Corpus Christi, Texas, United States
• Baylor University Medical Center — Dallas, Texas, United States
• Las Palmas Medical Center — El Paso, Texas, United States
• R.E. Thomason Hospital — El Paso, Texas, United States
• Del Sol Medical Center — El Paso, Texas, United States
• Cook Children's Medical Center — Fort Worth, Texas, United States
• St. Joseph Medical Center — Houston, Texas, United States
• Children's Memorial Hermann Hospital — Houston, Texas, United States
• Memorial Hermann Southwest Hospital — Houston, Texas, United States
• Clear Lake Regional Medical Center — Webster, Texas, United States

Full record on ClinicalTrials.gov

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