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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 is a clinical trial that has completed, run by Baylor College of Medicine. The registered enrollment target is 150 participants.

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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.

Trial Details

FieldValue
Enrollment Target 150 participants
Start Date 2010-10
Est. Completion 2023-09-12

Sponsor

Baylor College of Medicine

616 total trials

What the Registry Record Tells You About NCT01993043

The ClinicalTrials.gov registry entry for NCT01993043 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 150 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Baylor College of Medicine, which has 616 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 0 interventions.

NCT01993043 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.