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NCT00021645 · ClinicalTrials.gov registry record · Phase 1
Vitamin E to Treat Uveitis-Associated Macular Edema
A Phase 1 study, sponsored by National Eye Institute (NEI).
- Completed
- Registry status
- Phase 1
- Development phase
- 80
- Enrollment target
NCT00021645 is a Phase 1 study that has completed, run by National Eye Institute (NEI). The registered enrollment target is 80 participants.
The verdict
NCT00021645, a Phase 1 study, has completed, sponsored by National Eye Institute (NEI).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 80 participants
- Enrollment target
Study Summary
This study will evaluate whether vitamin E can help treat swelling of the macular area of the retina (the back part of the eye) associated with uveitis (inflammatory eye disease). The macula is responsible for sharp vision; swelling in this area is one cause of vision loss in uveitis patients. Macular swelling is also associated with eye problems related to diabetes. In these patients, the swelling is thought to be caused by a substance called vascular endothelial growth factor, or VEGF. High doses of vitamin E have been used to treat these eye problems in diabetics. This study is a first step to find out if vitamin E will help reduce the retinal swelling in uveitis, which may also be caused by VEGF. Patients 9 years of age and older with macular edema associated with uveitis may be eligible for this study. Candidates will be screened with the following tests and procedures: * Medical history and physical examination. This includes measurement of vital signs (blood pressure, pulse, temperature and breathing rate) and examination of the head and neck, heart, lungs, abdomen, arms and legs. * Eye examination. This includes measurement of visual acuity using a vision chart, measurement of eye pressure and examination of the pupils and eye movements. The pupils will be dilated with drops to permit examination of the back of the eye. * Fluorescein angiography. This test uses a yellow dye (fluorescein) to take photos of the retina. The fluorescein is injected into an arm vein and travels to the blood vessels in the eye. The camera flashes a blue light into the eye and takes pictures of the retina. The pictures show if the dye has leaked from the blood vessels into the retina. * Stereoscopic color fundus photography. These are photographs of the back of the eye, taken after the pupils have been dilated with drops. * Optical coherence tomography. This test measures the macular swelling. It is used to determine if the swelling is getting worse, better or staying the same. *
Interventions
- DRUG Vitamin E
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 80 participants |
| Start Date | 2001-07 |
| Est. Completion | 2004-06 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00021645
The ClinicalTrials.gov registry entry for NCT00021645 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 80 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Eye Institute (NEI), which has 221 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Vitamin E is the first listed.
NCT00021645 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00021645 about?
NCT00021645 is a clinical study titled "Vitamin E to Treat Uveitis-Associated Macular Edema". This study will evaluate whether vitamin E can help treat swelling of the macular area of the retina (the back part of the eye) associated with uveitis (inflammatory eye disease). The macula is responsible for sharp vision; swelling in this area is one cause of vision loss in uveitis patients. Macul...
What is the current status of trial NCT00021645?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 80 participants. The study started on 2001-07. Estimated completion is 2004-06.
What interventions are being tested in trial NCT00021645?
The interventions under investigation include: Vitamin E (DRUG).
Who is sponsoring clinical trial NCT00021645?
This trial is sponsored by National Eye Institute (NEI), which has 221 total clinical trials registered on ClinicalTrials.gov.
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