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NCT00702819 · ClinicalTrials.gov registry record · Phase 1
Pan-VEGF Blockade for the Treatment of Retinopathy of Prematurity
A Phase 1 study, sponsored by Vision Research Foundation.
- Terminated
- Registry status
- Phase 1
- Development phase
- 2
- Enrollment target
NCT00702819 is a Phase 1 study that was terminated before completion, run by Vision Research Foundation. The registered enrollment target is 2 participants.
The verdict
NCT00702819, a Phase 1 study, was terminated before completion, sponsored by Vision Research Foundation.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 2 participants
- Enrollment target
Study Summary
Retinopathy of Prematurity (ROP) is a leading cause of blindness in children in developed countries around the world, and an increasing cause of blindness in developing countries. The retina lines the inside of the eye. It functions as "film" within the camera which is the eye. When an infant is born prematurely, the vascular network necessary to nourish the retina has not fully developed. As a consequence, in some infants abnormal vessels proliferate instead of the normal ones - a condition known as ROP. The abnormal vessels carry scar tissue along with them, and may lead to retinal detachment and blindness if the eye is not treated. The Multicenter Trial of Cryotherapy for Retinopathy of Prematurity (CRYO-ROP) Study demonstrated that ablation of the peripheral avascular retina reduced the risk of poor structural and visual outcome due to retinal distortion or detachment in ROP (1980's). The ablated retina is not functional and is not amenable to regeneration. Peripheral retinal ablation is not universally effective in fostering regression of ROP. This is particularly true for an aggressive form of ROP (aggressive posterior ROP, or APROP) which typically afflicts profoundly premature and infirm neonates. In this subset of infants, progression of ROP to bilateral retinal detachment and blindness occurs despite timely and complete peripheral retinal laser ablation. Rationale The development of ROP is largely dependent on vascular endothelial growth factor (VEGF). When an infant is born prematurely the relatively hyperoxic environment the baby is introduced to shuts down the production of VEGF. Retinal maturation is delayed. Subsequently, at a time when intraocular VEGF levels would normally be declining late in the third trimester of pregnancy, abnormally high levels of VEGF are seen due to large areas of avascular retina and associated tissue hypoxia. The availability of FDA-approved drugs for anti-VEGF treatment renders it possible to treat such eyes off-label
Interventions
- DRUG Bevacizumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2 participants |
| Start Date | 2008-06 |
| Est. Completion | 2009-07 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00702819
The ClinicalTrials.gov registry entry for NCT00702819 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 2 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Vision Research Foundation, which has 2 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Bevacizumab is the first listed.
NCT00702819 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00702819 about?
NCT00702819 is a clinical study titled "Pan-VEGF Blockade for the Treatment of Retinopathy of Prematurity". Retinopathy of Prematurity (ROP) is a leading cause of blindness in children in developed countries around the world, and an increasing cause of blindness in developing countries. The retina lines the inside of the eye. It functions as "film" within the camera which is the eye. When an infant is bo...
What is the current status of trial NCT00702819?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 2 participants. The study started on 2008-06. Estimated completion is 2009-07.
What interventions are being tested in trial NCT00702819?
The interventions under investigation include: Bevacizumab (DRUG).
Who is sponsoring clinical trial NCT00702819?
This trial is sponsored by Vision Research Foundation, which has 2 total clinical trials registered on ClinicalTrials.gov.
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