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S0000B: Vitamin E and/or Selenium in Preventing Cataract and Age-Related Macular Degeneration in Men on SELECT SWOG-S0000 (SEE)

This study is currently recruiting participants.
Verified June 2013 by Southwest Oncology Group
Sponsor:
Collaborators:
National Cancer Institute (NCI)
National Eye Institute (NEI)
Information provided by (Responsible Party):
Southwest Oncology Group
ClinicalTrials.gov Identifier:
NCT00784225
First received: October 31, 2008
Last updated: June 12, 2013
Last verified: June 2013
History of Changes
  Purpose

RATIONALE: Aging may affect a person's vision. Vitamin E and/or selenium may help prevent cataracts or age-related macular degeneration in men receiving these drugs as part of a clinical trial for the prevention of prostate cancer.

PURPOSE: This clinical trial is studying vitamin E and/or selenium to see how well they work in preventing cataract and age-related macular degeneration in men enrolled on SELECT (SWOG-S0000).


Condition Intervention Phase
Cataract
Macular Degeneration
 Drug: selenium
Drug: vitamin E
Drug: vitamin E placebo
Drug: selenium placebo
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: S0000B: Prevention of Cataract and Age-Related Macular Degeneration With Vitamin E and Selenium - SELECT Eye Endpoints (SEE)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Southwest Oncology Group:

Primary Outcome Measures:
  • Visually significant age-related macular degeneration (AMD) [ Time Frame: Every 6 months ] [ Designated as safety issue: No ]
  • Cataract with best corrected visual-acuity of 20/30 [ Time Frame: Every 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Advanced AMD [ Time Frame: Every 6 months ] [ Designated as safety issue: No ]
  • Cataract extraction [ Time Frame: Every 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 2970
Study Start Date: July 2004
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Vitamin E + selenium placebo
vitamin E and selenium placebo daily for 7-12 years
 Drug: vitamin E
400 IU daily by mouth for 7-12 years
Other Name: alpha tocopherol
Drug: selenium placebo
daily for 7-12 years
Other Name: placebo
Experimental: Selenium + vitamin E placebo
selenium and vitamin E placebo daily for 7-12 years
 Drug: selenium
200 mcg daily for 7-12 years
Other Name: L-selenomethionine
Drug: vitamin E placebo
daily for 7-12 years
Other Name: placebo
Drug: selenium placebo
daily for 7-12 years
Other Name: placebo
Experimental: Vitamin E + selenium
vitamin E and selenium placebo daily for 7-12 years
 Drug: selenium
200 mcg daily for 7-12 years
Other Name: L-selenomethionine
Drug: vitamin E
400 IU daily by mouth for 7-12 years
Other Name: alpha tocopherol
Placebo Comparator: Vitamin E placebo + selenium placebo
vitamin E placebo and selenium placebo daily for 7-12 years
 Drug: vitamin E placebo
daily for 7-12 years
Other Name: placebo
Drug: selenium placebo
daily for 7-12 years
Other Name: placebo

Detailed Description:

OBJECTIVES:

Primary

  • To test whether vitamin E and/or selenium reduces the risk of visually significant age-related macular degeneration (AMD) in men enrolled on SELECT (SWOG-S0000).
  • To test whether vitamin E and/or selenium reduces the risk of cataract in these participants.

Secondary

  • To test whether vitamin E and/or selenium reduces the risk of advanced AMD in these participants.
  • To test whether vitamin E and/or selenium reduces the risk of cataract surgery and subtypes in these participants.

OUTLINE: This is a multicenter study.

Data from medical records obtained from the participant's ophthalmologist or optometrist are reviewed. Information from these records is then used to confirm baseline reports of age-related macular degeneration (AMD) as well as 6-month and annual reports of new diagnoses of AMD and cataract (or cataract surgery) made since the start of this study. Detailed questionnaires are also obtained from the participant's ophthalmologist or optometrist to provide information about the reported AMD or cataract diagnosis (e.g., date of initial diagnosis; best-corrected visual acuity at the time of diagnosis; date when visual acuity was first noted to be 20/30 or worse [if different from the date of initial diagnosis]; pathological findings observed when AMD was first diagnosed [e.g., drusen, retinal pigment epithelial hypo/hyperpigmentation, geographic atrophy, retinal pigment epithelial detachment, subretinal neovascular membrane, or disciform scar]; pathological findings observed when visual acuity was first noted to be 20/30 or worse; date when exudative [wet] AMD was first noted; presence of other ocular abnormalities that could explain or contribute to visual loss; whether AMD or cataract, by itself, are significant enough to cause vision to be reduced to 20/30 or worse; whether laser treatment or photodynamic therapy was performed for AMD; date of cataract extraction; etiology of cataract [e.g., age-related, traumatic, congenital, inflammatory, or surgery- or steroid-induced]; and cataract type [e.g., nuclear, cortical, posterior subcapsular, or other]).

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

DISEASE CHARACTERISTICS:

  • Enrolled on the Selenium and Vitamin E Prostate Cancer Prevention Trial (SELECT) SWOG-S0000

  • Diagnosis of 1 of the following:

    • Age-related macular degeneration (AMD) at baseline or at follow-up

    • Cataract or a cataract extraction at follow-up (Closed for accrual as of 10/01/29)

      • Participants with a prior diagnosis of cataract at baseline followed by another cataract event (cataract diagnosis or a cataract extraction) at follow-up are not eligible
      • Participants with a prior diagnosis of cataract at baseline followed by a diagnosis of AMD at follow-up are eligible

PATIENT CHARACTERISTICS:

  • See Disease Characteristics

PRIOR CONCURRENT THERAPY:

  • Not applicable
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00784225

Contacts
Contact: Dana Sparks, MAT 210-614-8808 ext 1004

Locations
United States, Massachusetts
Harvard Medical School Recruiting
Boston, Massachusetts, United States, 02215
Contact: William Christen         wchristen@rics.bwh.harvard.edu    
Principal Investigator: William Christen, ScD            
Sponsors and Collaborators
Southwest Oncology Group
National Cancer Institute (NCI)
National Eye Institute (NEI)
Investigators
Study Chair: William Christen, ScD Dana-Farber/Brigham and Women's Cancer Center
  More Information

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Southwest Oncology Group
ClinicalTrials.gov Identifier: NCT00784225     History of Changes
Other Study ID Numbers: CDR0000617778, S0000B, U10CA037429, R01EY014418
Study First Received: October 31, 2008
Last Updated: June 12, 2013
Health Authority: United States: Federal Government
United States: Food and Drug Administration

Keywords provided by Southwest Oncology Group:
cataract
advanced macular degeneration

Additional relevant MeSH terms:
Selenium
Macular Degeneration
Cataract
Retinal Degeneration
Retinal Diseases
Eye Diseases
Lens Diseases
Vitamin E
Alpha-Tocopherol
Tocopherols
 Tocotrienols
Vitamins
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents

ClinicalTrials.gov processed this record on June 18, 2013