CataractPhase 3SEENCT00784225

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

A Phase 3 study testing selenium and vitamin E in people with Cataract and Macular Degeneration, run by SWOG Cancer Research Network 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

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. Read more about this study

Who is it for?: Ages 50 to 120 years, men onlyHealthy volunteers can take part
Conditions the study is for: Cataract, Macular Degeneration
What is being tested?: selenium and vitamin E
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 13,475 participants
Where: 1 siteUnited States
Study dates: Jul 2004to May 2018
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 50 to 120 years
Men only
Healthy volunteers accepted
Adult, Older adult

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Harvard Medical School
Boston, Massachusetts, 02215

Other trials in United States

About this study

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

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).

Read the 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]).

Conditions: Cataract, Macular Degeneration
Being tested: selenium, vitamin E, vitamin E placebo, selenium placebo
Keywords: cataract, advanced macular degeneration
Medical subject headings: Cataract, Macular Degeneration

What participants receive

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

seleniumDrug
Also called L-selenomethionine
200 mcg daily for 7-12 years
vitamin EDrug
Also called alpha tocopherol
400 IU daily by mouth for 7-12 years
vitamin E placeboDrug
Also called placebo
daily for 7-12 years
selenium placeboDrug
Also called placebo
daily for 7-12 years

Study groups in NCT00784225
Study group	Role	What they receive
Vitamin E + selenium placebo	Experimental	vitamin E and selenium placebo daily for 7-12 years Receives: Drug: vitamin E; Drug: selenium placebo
Selenium + vitamin E placebo	Experimental	selenium and vitamin E placebo daily for 7-12 years Receives: Drug: selenium; Drug: vitamin E placebo; Drug: selenium placebo
Vitamin E + selenium	Experimental	vitamin E and selenium placebo daily for 7-12 years Receives: Drug: selenium; Drug: vitamin E
Vitamin E placebo + selenium placebo	Placebo comparator	vitamin E placebo and selenium placebo daily for 7-12 years Receives: Drug: vitamin E placebo; Drug: selenium placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With Visually Significant Age-related Macular Degeneration (AMD)
Visually significant age-related AMD was defined as incident AMD responsible for reduction in best corrected visual acuity to 20/30 or worse(AMD 20/30)
Measured: Every 6 months, up to 7 years
Number of Participants With Cataract and Best Corrected Visual-acuity of 20/30
Incident cataract was defined as lens opacity diagnosed after randomization but prior to end of study, age-related in origin, and best-corrected visual acuity of 20/30 or worse attributable to the opacity.
Measured: Every 6 months, up to 7 years

Secondary outcomes (2)

Number of Participants With Advanced AMD
Advanced AMD was defined as the occurrence of disciform scars, or geographic atrophy or retinal pigment epithelium (RPE) detachment in either or both eyes at AMD diagnosis.
Measured: Every 6 months, up to 7 years
Number of Participants Who Underwent Cataract Extraction
Cataract extraction was defined as the surgical removal of an incident cataract.
Measured: Every 6 months, up to 7 years

Timeline

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

Jul 2004May 2018

First posted3 Nov 2008 (estimated)
Study startJul 2004
Primary completionNov 2017
Study completionMay 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for CataractStudies of the same condition, open and under way.
More trials run by SWOG Cancer Research NetworkThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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 3
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Factorial
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 13,475 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00784225
Sponsor's protocol ID: CDR0000617778
Other IDs: S0000B, U10CA037429, R01EY014418
Acronym: SEE
Status last verified: Aug 2019
First submitted: 31 Oct 2008
Last updated: 14 Aug 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Goodman PJ, Tangen CM, Darke AK, Arnold KB, Hartline J, Yee M, Anderson K, Caban-Holt A, Christen WG, Cassano PA, Lance P, Klein EA, Crowley JJ, Minasian LM, Meyskens FL. Opportunities and challenges in incorporating ancillary studies into a cancer prevention randomized clinical trial. Trials. 2016 Aug 12;17:400. doi: 10.1186/s13063-016-1524-9.
PubMed 27519183
Christen WG, Glynn RJ, Gaziano JM, Darke AK, Crowley JJ, Goodman PJ, Lippman SM, Lad TE, Bearden JD, Goodman GE, Minasian LM, Thompson IM Jr, Blanke CD, Klein EA. Age-related cataract in men in the selenium and vitamin e cancer prevention trial eye endpoints study: a randomized clinical trial. JAMA Ophthalmol. 2015 Jan;133(1):17-24. doi: 10.1001/jamaophthalmol.2014.3478.
PubMed 25232809

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Cataract trials

Study at a glance

From the registry record, last updated by the sponsor on 14 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: S0000B: Prevention of Cataract and Age-Related Macular Degeneration With Vitamin E and Selenium - SELECT Eye Endpoints (SEE)
ClinicalTrials.gov ID: NCT00784225
Acronym / sponsor ID: SEE / CDR0000617778
Conditions: Cataract, Macular Degeneration
Keywords: cataract, advanced macular degeneration
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 13,475 participants (actual)
Lead sponsor: SWOG Cancer Research NetworkResearch network
Collaborators: National Cancer Institute (NCI), National Eye Institute (NEI)
Study start: Jul 2004
Primary completion: Nov 2017 (actual)
Study completion: May 2018 (actual)
First posted: 3 Nov 2008 (estimated)
Results: Posted 23 Jul 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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).

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.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Factorial
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
Vitamin E + selenium placebo	Experimental	Drug: vitamin E, Drug: selenium placebovitamin E and selenium placebo daily for 7-12 years
Selenium + vitamin E placebo	Experimental	Drug: selenium, Drug: vitamin E placebo, Drug: selenium placeboselenium and vitamin E placebo daily for 7-12 years
Vitamin E + selenium	Experimental	Drug: selenium, Drug: vitamin Evitamin E and selenium placebo daily for 7-12 years
Vitamin E placebo + selenium placebo	Placebo comparator	Drug: vitamin E placebo, Drug: selenium placebovitamin E placebo and selenium placebo daily for 7-12 years

Who may qualify

Ages: 50 to 120 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
seleniumAlso: L-selenomethionine200 mcg daily for 7-12 years	Drug	Selenium + vitamin E placebo, Vitamin E + selenium
vitamin EAlso: alpha tocopherol400 IU daily by mouth for 7-12 years	Drug	Vitamin E + selenium, Vitamin E + selenium placebo
vitamin E placeboAlso: placebodaily for 7-12 years	Drug	Selenium + vitamin E placebo, Vitamin E placebo + selenium placebo
selenium placeboAlso: placebodaily for 7-12 years	Drug	Selenium + vitamin E placebo, Vitamin E + selenium placebo, Vitamin E placebo + selenium placebo

Primary outcome

Number of Participants With Visually Significant Age-related Macular Degeneration (AMD)
Time frame: Every 6 months, up to 7 years
Visually significant age-related AMD was defined as incident AMD responsible for reduction in best corrected visual acuity to 20/30 or worse(AMD 20/30)
Number of Participants With Cataract and Best Corrected Visual-acuity of 20/30
Time frame: Every 6 months, up to 7 years
Incident cataract was defined as lens opacity diagnosed after randomization but prior to end of study, age-related in origin, and best-corrected visual acuity of 20/30 or worse attributable to the opacity.

2 secondary outcomes

Number of Participants With Advanced AMD
Time frame: Every 6 months, up to 7 years
Number of Participants Who Underwent Cataract Extraction
Time frame: Every 6 months, up to 7 years

Results and safety

Results posted to the registry on 23 Jul 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Selenium + Vitamin E Placebo	3,375	3,375
Selenium + Vitamin E	3,357	3,357
Vitamin E Placebo + Selenium Placebo	3,369	3,369
Vitamin E + Selenium Placebo	3,374	3,374

Primary outcome: Number of Participants With Visually Significant Age-related Macular Degeneration (AMD)

Time frame: Every 6 months, up to 7 years. Count of participants. Unit: Participants

Measure	AMD: Selenium Active n = 6690	AMD: Selenium Placebo n = 6699	AMD: Vitamin E Active n = 6686	AMD: Vitamin E Placebo n = 6703
AMD cases	9	12	9	12
non-AMD cases	6681	6687	6677	6691

AMD: Selenium Active vs AMD: Selenium Placebo: Cox Proportional Hazard: 0.75 (95% CI 0.32 to 1.79), p = 0.52, Regression, Cox
AMD: Vitamin E Active vs AMD: Vitamin E Placebo: Cox Proportional Hazard: 0.75 (95% CI 0.31 to 1.77), p = 0.51, Regression, Cox

Population analysed: Marginal analyses were performed with arms pooled based on active vs. placebo selenium or vitamin E.

Primary outcome: Number of Participants With Cataract and Best Corrected Visual-acuity of 20/30

Time frame: Every 6 months, up to 7 years. Count of participants. Unit: Participants

Measure	Cataract: Selenium Active n = 5594	Cataract: Selenium Placebo n = 5673	Cataract: Vitamin E Active n = 5633	Cataract: Vitamin E Placebo n = 5634
Cataract cases	185	204	197	192
non-cataract cases	5409	5469	5436	5442

Cataract: Selenium Active vs Cataract: Selenium Placebo: Cox Proportional Hazard: 0.91 (95% CI 0.75 to 1.11), p = 0.37, Regression, Cox
Cataract: Vitamin E Active vs Cataract: Vitamin E Placebo: Cox Proportional Hazard: 1.02 (95% CI 0.84 to 1.25), p = 0.81, Regression, Cox

Population analysed: Marginal analyses were performed with arms pooled based on active vs. placebo selenium or vitamin E.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Every 6 months while the participant is receiving study supplements, up to 7 years. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Selenium + Vitamin E Placebo	44 of 3,374 (1.3%)	243 of 3,374 (7.2%)	151 of 3,374
Selenium + Vitamin E	41 of 3,356 (1.2%)	243 of 3,356 (7.2%)	159 of 3,356
Placebo	50 of 3,366 (1.5%)	261 of 3,366 (7.8%)	150 of 3,366
Vitamin E + Selenium Placebo	45 of 3,374 (1.3%)	267 of 3,374 (7.9%)	147 of 3,374

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 27519183Goodman PJ, Tangen CM, Darke AK, Arnold KB, Hartline J, Yee M, Anderson K, Caban-Holt A, Christen WG, Cassano PA, Lance P, Klein EA, Crowley JJ, Minasian LM, Meyskens FL. Opportunities and challenges in incorporating ancillary studies into a cancer prevention randomized clinical trial. Trials. 2016 Aug 12;17:400. doi: 10.1186/s13063-016-1524-9.
Derived from this study: PubMed 25232809Christen WG, Glynn RJ, Gaziano JM, Darke AK, Crowley JJ, Goodman PJ, Lippman SM, Lad TE, Bearden JD, Goodman GE, Minasian LM, Thompson IM Jr, Blanke CD, Klein EA. Age-related cataract in men in the selenium and vitamin e cancer prevention trial eye endpoints study: a randomized clinical trial. JAMA Ophthalmol. 2015 Jan;133(1):17-24. doi: 10.1001/jamaophthalmol.2014.3478.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

William Christen, ScD study chair

Dana-Farber/Brigham and Women's Cancer Center

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing selenium and vitamin E in people with Cataract and Macular Degeneration, run by SWOG Cancer Research Network 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?

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 14 Aug 2019. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 Jul 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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.

What does the primary outcome measure?

Number of Participants With Visually Significant Age-related Macular Degeneration (AMD) (time frame: Every 6 months, up to 7 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00784225, which also lists 2 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 14 Aug 2019.