An observational study in ROP Threshold, sponsored by Baylor College of Medicine. Completed at 2 sites in United States. Open to participants aged 30 Weeks to 40 Weeks. Per ClinicalTrials.gov, last updated 2023-09-13.
Sponsored by Baylor College of Medicine · Observational
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.
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.
175 studies on the registry are indexed under Retinopathy of Prematurity; 28 are open to participants now.
This study's enrollment of 150 is below the median of 183 across 56 observational studies indexed under Retinopathy of Prematurity.
Browse Retinopathy of Prematurity studies →Baylor College of Medicine is the lead sponsor of 734 studies on the registry; 110 are open to participants now.
Of its 83 completed or terminated interventional studies of FDA-regulated products, 44 (53%) have results posted.
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Premature infants
Premature infants who were scheduled to receive laser or BEvacizumab treatment for type I ROP .
Exclusion Criteria:
Vision
Visual acuity will be measured at age of 3 and 5 years with HOTV card.
Time frame: 5 years
The changes of neurodevelopment outcome from birth to 5 years of age
Neurodevelopmental assessments will be performed by board-certified, developmental-behavioral pediatric and neurodevelopmental disability pediatricians. Each neurodevelopmental assessment includes a developmental history, direct behavioral observations, and direct developmental testing using the Revised Gesell Developmental Schedules; the Motor Quotient will be used to assess gross motor development; and the Capute Scales will be used used to assess non-verbal, visual-motor problem-solving development and speech and language development.
Time frame: 1 to 5 years old
This study is completed, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.
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Baylor College of Medicine