Vitamin E to Treat Uveitis-Associated Macular Edema

Phase 1

Completed

• Conditions: Cystoid Macular Edema; Uveitis

• Registration Number: NCT00021645
• Lead Sponsor: National Eye Institute (NEI)

Brief 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.

* 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.

Detailed Description

We plan to test the efficacy of alpha-tocopherol (vitamin E), a potent inhibitor of the protein kinase C pathway in vascular endothelial growth factor (VEGF) induced vascular permeability, for the treatment of uveitis-associated macular edema. This will be performed using a double-masked, randomized study in which uveitis patients with macular edema will receive either alpha-tocopherol or placebo. This study should be considered a pilot study that will provide information on design and outcome measurement for the development of a larger, definitive, future study. Patients will receive 1600IU/day of Vitamin E or placebo for 4 months. The primary outcome will be a visual acuity increase of 10 letters or more from baseline to month 4. Secondary outcomes are total area of leakage and macular height as determined by fluorescein angiography, changes in CME as measured by stereoscopic color photographs, optical coherence tomography (OCT), the need for periocular injections or additional systemic immunomodulatory medications, and the NEI VFQ summary score.

Study Timeline

• Study Start: 2001-07
• Study First Submitted: 2001-07-26
• Study First Submitted QC: 2001-07-26
• Study First Posted: 2001-07-27
• Status Verified: 2004-06
• Study Completion: 2004-06
• Last Update Submitted: 2008-03-03
• Last Update Posted: 2008-03-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

National Eye Institute (NEI); 🇺🇸 Bethesda, Maryland, United States