Status:
UNKNOWN
Bevacizumab Eliminates the Angiogenic Threat for Retinopathy of Prematurity
Lead Sponsor:
The University of Texas Health Science Center, Houston
Conditions:
Retinopathy of Prematurity
Eligibility:
All Genders
4-22 years
Phase:
PHASE2
Brief Summary
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.
Detailed Description
This phase 2 study assessed the anti-neovascularization activity of intravitreal bevacizumab, as determined by regression of neovascular vessels of retinopathy of prematurity (ROP), in neonates with a...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
March 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2020
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT00622726
Start Date
March 1 2008
End Date
August 1 2020
Last Update
June 6 2017
Active Locations (15)
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1
Huntington Memorial Hospital
Pasadena, California, United States, 91109
2
Presbyterian-St. Luke's Hospital
Denver, Colorado, United States, 80218
3
OSF St. Francis Medical Center-Children's Hospital of Illinois
Peoria, Illinois, United States, 61637
4
Palmetto Health Richland Hospital
Columbia, South Carolina, United States, 29203