Vitamin E to Treat Uveitis-Associated Macular Edema
Public ClinicalTrials.gov record NCT00021645. 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
Randomized Masked Study to Evaluate the Use of Vitamin E in the Treatment of Uveitis-Associated Macular Edema
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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. * Blood tests. About a tablespoon of blood is drawn to measure inflammation and cell counts and side effects of treatment. * Pregnancy test. All women of child-bearing potential are tested for pregnancy. Participants will be randomly assigned to daily treatment with oral high-dose vitamin E (1600 units) or placebo (a pill with no active ingredient) for 4 months. They will be examined at 2 months and 4 months with the same tests performed for screening and will return for a final clinic visit 1 month after treatment has ended.
Study identification
- NCT ID
- NCT00021645
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 80 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- Not listed
- 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
- Jun 30, 2001
- Primary completion
- Not listed
- Completion
- May 31, 2004
- Last update posted
- Mar 3, 2008
2001 – 2004
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| National Eye Institute (NEI) | Bethesda | Maryland | 20892 | — |
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 NCT00021645, 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 Mar 3, 2008 · Synced Sep 5, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00021645 live on ClinicalTrials.gov.