39946-I Laser and Bevacizumab Treatment for Retinopathy of Prematurity
Public ClinicalTrials.gov record NCT01993043. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Comparison of Vision and Development Outcomes in Laser- and Bevacizumab-Treated Infants With Retinopathy of Prematurity
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT01993043
- Recruitment status
- Completed
- Study type
- Observational
- Phase
- Not listed
- Enrollment
- 150 participants
Conditions and interventions
Conditions
Interventions
Not listed
Eligibility (public fields only)
- Age range
- 30 Weeks to 40 Weeks
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Sep 30, 2010
- Primary completion
- Sep 30, 2020
- Completion
- Sep 11, 2023
- Last update posted
- Sep 12, 2023
2010 – 2023
United States locations
- U.S. sites
- 2
- U.S. states
- 1
- U.S. cities
- 2
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Baylor College of Medicine | Houston | Texas | 77030 | — |
| TTUHSC | Lubbock | Texas | 79430 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01993043, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 12, 2023 · Synced Sep 28, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01993043 live on ClinicalTrials.gov.