Vitamin E and Selenium in Preventing Cataracts and Age-Related Macular Degeneration

  • Resize font
  • Print
  • Email
  • Facebook
  • Twitter
  • Google+
  • Pinterest

Basic Trial Information

PhaseTypeAgeTrial IDs
No phase specifiedNatural history/Epidemiology55 and over (50 and over for African Americans)S0000B
NCI-2009-00751, CDR0000617778, SWOG-S0000B, NCT00784225

Trial Description

Summary

This clinical trial studies vitamin E and selenium in preventing cataracts and age-related macular degeneration. Vitamin E and selenium are antioxidants that may prevent or slow the growth of cataracts or age-related macular degeneration.

Further Study Information

PRIMARY OBJECTIVES:

I. To test whether 400 mg of vitamin E reduces the risk of visually-significant age-related macular degeneration (AMD).

II. To test whether 200 ug of selenium reduces the risk of visually-significant AMD.

III. To test whether 400 mg of vitamin E reduces the risk of cataract.

IV. To test whether 200 ug of selenium reduces the risk of cataract.

SECONDARY OBJECTIVES:

I. To test whether 400 mg of vitamin E reduces the risk of advanced AMD.

II. To test whether 200 ug of selenium reduces the risk of advanced AMD.

III. To test whether 400 mg of vitamin E reduces the risk of cataract surgery and subtypes.

IV. To test whether 200 ug of selenium reduces the risk of cataract surgery and subtypes.

OUTLINE:

Participant information on previous diagnoses of cataract and AMD are collected by questionnaires at baseline, 6 months, and annually. Medical records are collected and reviewed for patients with a diagnosis of AMD.

Eligibility Criteria

Inclusion Criteria:

Participants must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines before SEE procedures are initiated; participants must have signed an applicable medical records release form and it must have been sent to Dr. William Christen at the SELECT Eye Endpoints (SEE) Center in Boston, MA by FAX (FAX #: 617/278-2030) immediately after registration to SEE

At the time of participant registration, the treating institution's name and identification (ID) number must be provided to the Statistical Center in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered into the database

The potential S0000B (SEE) participant must be a SELECT participant at the time of registration to SEE; participants may be registered to SEE at any time after SELECT randomization; participants are registered only after they report an eye event of interest

The potential participant must report a diagnosis of age-related macular degeneration (AMD) at baseline (contact 010) or at follow-up, or a diagnosis of cataract or a cataract extraction at follow-up (effective November 1, 2009 accrual of new participants based solely on a diagnosis of cataract or a cataract extraction at follow-up is closed)

The potential participant must report a diagnosis of age-related macular degeneration (AMD) at baseline (contact 010) or at follow-up, or a diagnosis of cataract or a cataract extraction at follow-up (effective November 1, 2009 accrual of new participants

based solely on a diagnosis of cataract or a cataract extraction at follow-up is closed)

A participant who reported a previous diagnosis of cataract at baseline (contact 010), then reports a cataract event (another cataract diagnosis or a cataract extraction) at follow-up, is not eligible

A participant who reported a previous diagnosis of cataract at baseline (contact 010), then reports a diagnosis of AMD at follow-up is eligible

Trial Contact Information

Trial Lead Organizations / Sponsors / Collaborators

Southwest Oncology Group (SWOG) Research Base

  • National Cancer Institute
Frank Louis Meyskens, Principal Investigator

Trial Sites

U.S.A.

California
Upland

Lionel B Katchem Oncology

Frank Louis Meyskens
Ph: 714-456-6310
Email: flmeyske@uci.edu

Frank Louis Meyskens
Principal Investigator

Georgia
Tucker

Kaiser Southeast Permanente Medical Group Incorporated

Frank Louis Meyskens
Ph: 714-456-6310
Email: flmeyske@uci.edu

Frank Louis Meyskens
Principal Investigator

Kansas
Topeka

Cotton-O'Neil Clinic PA

Frank Louis Meyskens
Ph: 714-456-6310
Email: flmeyske@uci.edu

Frank Louis Meyskens
Principal Investigator

Canada

British Columbia
Vancouver

Vancouver General Hospital-Gordon and Leslie Diamond Health Care Centre

Frank Louis Meyskens
Ph: 714-456-6310
Email: flmeyske@uci.edu

Frank Louis Meyskens
Principal Investigator

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00784225

Note: Information about participating sites on pharmaceutical industry trials may be incomplete. Please visit the ClinicalTrials.gov record via the link above for more information about participating sites.