Vitamin E to Treat Uveitis-Associated Macular Edema

March 3, 2008 updated by: National Eye Institute (NEI)

Randomized Masked Study to Evaluate the Use of Vitamin E in the Treatment of 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. 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 Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment

80

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Bethesda, Maryland, United States, 20892
        • National Eye Institute (NEI)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

INCLUSION CRITERIA:

Patients with documented cystoid macular edema associated with intraocular inflammatory disease. This should be documented both by clinical examination and by fluorescein angiography and should be agreed upon by two independent observers.

Patients must have at least one eye with best corrected visual acuity of 20/32 or less (as measured by the ETDRS chart) and macular edema. These will be considered eligible eyes.

A patient must have at lease one eligible eye with clinical opacity grades of less than or equal to 1+ for posterior sub-capsular opacity and less than or equal to 2+ for nuclear opacity.

Patients 9 years and above, of either sex (non-pregnant females), who carry the diagnosis of endogenous anterior, intermediate, posterior, or panuveitis.

Patients may be receiving systemic therapy for the treatment of their cystoid macular edema, or may have been treated for the cystoid macular edema in the past.

Vitreous haze in both eyes equal to or less than 1+ cell and 1+ haze.

The patient or patient's guardian must understand and sign the protocol informed consent and/or assent document.

EXCLUSION CRITERIA:

Periocular injection of steroids within the previous month or potential need for injections during the study.

Systemic immunomodulatory agent(s) added or increased in dosage (greater than 20%) within the last two months, or potential need for any increase during the study.

Patients requiring prednisone greater than 30 mg per day at the time of enrollment.

Vitamin E supplementation over and above the amount in a multivitamin (60 IU/day) one month prior to entry into the study.

History of hypersensitivity to fluorescein.

Unclear media which precludes assessment of cystoid macular edema in eligible eye(s), such as a cataract or vitreal opacity.

Evidence of a macular subretinal neovascular net or a macular hole in the eligible eye(s).

Prior or current macular detachment in eligible eye(s).

Concurrent coumadin (warfarin) therapy or known bleeding diathesis.

Concurrent treatment with a new investigational drug.

Malabsorption syndrome.

Concurrent administration of anti-cholesterol resin medications (e.g. cholestyramine).

Concurrent administration of the anti-obesity drug orlistat.

Pregnant or lactating women.

Medical problems that make consistent follow-up over the treatment period unlikely (e.g. stroke, severe myocardial infarction, terminal carcinoma).

Inability to comply with the study requirements.

Severe optic nerve atrophy in eligible eye(s).

History of intercranial bleeds.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Eye Institute (NEI)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2001

Study Completion

June 1, 2004

Study Registration Dates

First Submitted

July 26, 2001

First Submitted That Met QC Criteria

July 26, 2001

First Posted (Estimate)

July 27, 2001

Study Record Updates

Last Update Posted (Estimate)

March 4, 2008

Last Update Submitted That Met QC Criteria

March 3, 2008

Last Verified

June 1, 2004

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 010214
  • 01-EI-0214

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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