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S0000B: Prevention of Cataract and Age-Related Macular Degeneration With Vitamin E and Selenium - SELECT Eye Endpoints (SEE)


Phase 3
50 Years
N/A
Open (Enrolling)
Male
Cataract, Macular Degeneration

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Trial Information

S0000B: Prevention of Cataract and Age-Related Macular Degeneration With Vitamin E and Selenium - SELECT Eye Endpoints (SEE)


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]).

Inclusion 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

Type of Study:

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

Outcome Measure:

Visually significant age-related macular degeneration (AMD)

Outcome Time Frame:

Every 6 months

Safety Issue:

No

Principal Investigator

William Christen, ScD

Investigator Role:

Study Chair

Investigator Affiliation:

Dana-Farber/Brigham and Women's Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000617778

NCT ID:

NCT00784225

Start Date:

July 2004

Completion Date:

June 2014

Related Keywords:

  • Cataract
  • Macular Degeneration
  • cataract
  • advanced macular degeneration
  • Macular Degeneration
  • Cataract

Name

Location

Harvard Medical SchoolBoston, Massachusetts  02115