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Cystoid Macular EdemaPhase 1NCT00021645

Vitamin E to Treat Uveitis-Associated Macular Edema

A Phase 1 study testing Vitamin E in people with Cystoid Macular Edema and Uveitis, run by National Eye Institute (NEI) at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Any age
Conditions the study is for
Cystoid Macular Edema, Uveitis
What is being tested?
Vitamin E
How many people
80 participants
Where
1 siteUnited States
Study dates
Jul 2001to Jun 2004
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 18Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • National Eye Institute (NEI)

    Bethesda, Maryland, 20892

Other trials in United States

About this study

Official title: 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:

Read more
  • 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.

Read the 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.

Being tested
Vitamin E
Keywords
Corticosteroids, Immunosuppressives, Intraocular Inflammatory Disease, Uveitis, Macular Edema
Medical subject headings
Macular Edema, Uveitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Vitamin EDrug

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jul 2001 (estimated)
  2. Study startJul 2001
  3. Study completionJun 2004

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Enrolment
80 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00021645
Sponsor's protocol ID
010214
Other IDs
01-EI-0214
Status last verified
Jun 2004
First submitted
26 Jul 2001
Last updated
4 Mar 2008
Results posted
No

Publications

  • Nussenblatt RB, Kaufman SC, Palestine AG, Davis MD, Ferris FL 3rd. Macular thickening and visual acuity. Measurement in patients with cystoid macular edema. Ophthalmology. 1987 Sep;94(9):1134-9. doi: 10.1016/s0161-6420(87)33314-7.

    PubMed 3684231

  • Vinores SA, Chan CC, Vinores MA, Matteson DM, Chen YS, Klein DA, Shi A, Ozaki H, Campochiaro PA. Increased vascular endothelial growth factor (VEGF) and transforming growth factor beta (TGFbeta) in experimental autoimmune uveoretinitis: upregulation of VEGF without neovascularization. J Neuroimmunol. 1998 Aug 14;89(1-2):43-50. doi: 10.1016/s0165-5728(98)00075-7.

    PubMed 9726824

  • Ozaki H, Hayashi H, Vinores SA, Moromizato Y, Campochiaro PA, Oshima K. Intravitreal sustained release of VEGF causes retinal neovascularization in rabbits and breakdown of the blood-retinal barrier in rabbits and primates. Exp Eye Res. 1997 Apr;64(4):505-17. doi: 10.1006/exer.1996.0239.

    PubMed 9227268

  • Alberola AH, Nogal NB, Miranda AB, Lipson DA, Tombs L, Han MK. The Effect of Patient Sex on Treatment Outcomes in COPD: A Post Hoc Analysis of the IMPACT Trial. Chronic Obstr Pulm Dis. 2024 Nov 22;11(6):591-603. doi: 10.15326/jcopdf.2024.0541.

    PubMed 39531369

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Vitamin E in people with Cystoid Macular Edema and Uveitis, run by National Eye Institute (NEI) at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Mar 2008. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00021645, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2008.

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