39946-I Laser and Bevacizumab Treatment for Retinopathy of Prematurity
| Status: | Recruiting |
|---|---|
| Conditions: | Ocular, Ocular |
| Therapuetic Areas: | Ophthalmology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 2/2/2017 |
| Start Date: | October 2010 |
| End Date: | October 2018 |
| Contact: | Lingkun Kong, MD, Ph.D |
| Email: | lxxkong@gmail.com |
| Phone: | 832-8223222 |
Comparison of Vision and Development Outcomes in Laser- and Bevacizumab-Treated Infants With Retinopathy of Prematurity
Retinopathy of prematurity (ROP) is a leading cause of childhood blindness. Vascular
endothelium growth factor (VEGF) is an important component of this disease. The goal of
treatment is to reduce the production of VEGF in the immature retina and to eliminate the
abnormal growth of new vessels. Currently, laser photocoagulation of the peripheral
avascular retina is the treatment standard. Intravitreal injection of anti-VEGF antibody
Bevacizumab (IVB) has been used clinically off-label as an alternative therapy. However,
VEGF is important for the development of neurons and vessels in the systemic organs in
premature infants. Pharmaceutical study showed that IVB was absorbed into the bloodstream.
It is unclear if the systemic absorption of Bevacizumab is dose related, and the short and
longterm effects on ocular and systemic systems, especially neurological development. In
this study, our goals are to establish the pharmacokinetics of Bevacizumab in the premature
infant and to compare the short and long-term vision and neurodevelopmental outcomes of
infants treated with IVB compared to laser ROP.
endothelium growth factor (VEGF) is an important component of this disease. The goal of
treatment is to reduce the production of VEGF in the immature retina and to eliminate the
abnormal growth of new vessels. Currently, laser photocoagulation of the peripheral
avascular retina is the treatment standard. Intravitreal injection of anti-VEGF antibody
Bevacizumab (IVB) has been used clinically off-label as an alternative therapy. However,
VEGF is important for the development of neurons and vessels in the systemic organs in
premature infants. Pharmaceutical study showed that IVB was absorbed into the bloodstream.
It is unclear if the systemic absorption of Bevacizumab is dose related, and the short and
longterm effects on ocular and systemic systems, especially neurological development. In
this study, our goals are to establish the pharmacokinetics of Bevacizumab in the premature
infant and to compare the short and long-term vision and neurodevelopmental outcomes of
infants treated with IVB compared to laser ROP.
This study will enroll preterm infants who were scheduled to receive treatment for ROP by
laser or Bevacizumab. We will observe the patients in the hospital for the cure of ROP until
54 weeks' postmenstrual age. We will check the changes of chemicals in the blood and observe
short-term and long-term effects on visual system, brain and other body organs. Descriptive
statistics from a two sample t-test or Fisher's exact test will be used to compare the short
and long-term vision and neurological development outcomes. We predefined a statistical
significance level p=0.05.
laser or Bevacizumab. We will observe the patients in the hospital for the cure of ROP until
54 weeks' postmenstrual age. We will check the changes of chemicals in the blood and observe
short-term and long-term effects on visual system, brain and other body organs. Descriptive
statistics from a two sample t-test or Fisher's exact test will be used to compare the short
and long-term vision and neurological development outcomes. We predefined a statistical
significance level p=0.05.
Inclusion Criteria:
Premature infants who were scheduled to receive laser or BEvacizumab treatment for type I
ROP .
Exclusion Criteria:
1. Have unilateral or Bilateral ROP Stage 4 or 5 ROP;
2. Lack of signed consent by the parent or legal guardian.
We found this trial at
1
site
1200 Moursund Street
Houston, Texas 77030
Houston, Texas 77030
(713) 798-4951
Phone: 832-822-3222
Baylor College of Medicine Baylor College of Medicine in Houston, the only private medical school...
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