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NCT01993043 · ClinicalTrials.gov registry record
39946-I Laser and Bevacizumab Treatment for Retinopathy of Prematurity
A clinical trial, sponsored by Baylor College of Medicine.
- Completed
- Registry status
- 150
- Enrollment target
NCT01993043: Completed study, sponsored by Baylor College of Medicine.
NCT01993043 is a clinical trial that has completed, run by Baylor College of Medicine. The registered enrollment target is 150 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01993043 has completed, sponsored by Baylor College of Medicine.
- COMPLETED
- Registry status
- 150 participants
- Enrollment target
Study Summary
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.
Primary Outcome
Visual acuity will be measured at age of 3 and 5 years with HOTV card.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 150 participants |
| Start Date | 2010-10 |
| Est. Completion | 2023-09-12 |
What the finished NCT01993043 record still lists
NCT01993043 is an observational study that tracks outcomes without assigning an intervention. The registered 150 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 0 interventions.
NCT01993043 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01993043 about?
NCT01993043 is a clinical study titled "39946-I Laser and Bevacizumab Treatment for 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. Curre...
What is the current status of trial NCT01993043?
This trial is currently completed. The enrollment target is 150 participants. The study started on 2010-10. Estimated completion is 2023-09-12.
Who is sponsoring clinical trial NCT01993043?
This trial is sponsored by Baylor College of Medicine, which has 616 total clinical trials registered on ClinicalTrials.gov.
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