Randomized Clinical Trial for Retinitis Pigmentosa

The recruitment status of this study is unknown because the information has not been verified recently.

Verified December 2007 by National Eye Institute (NEI).
Recruitment status was Active, not recruiting

Sponsor:

Information provided by:

National Eye Institute (NEI)

ClinicalTrials.gov Identifier:

NCT00346333

First received: June 27, 2006

Last updated: March 23, 2010

Last verified: December 2007

History of Changes

Tracking Information

First Received Date ^ICMJE

June 27, 2006

Last Updated Date

March 23, 2010

Start Date ^ICMJE

August 2003

Estimated Primary Completion Date

December 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Total point score for the 30-2 program of the Humphrey Field analyzer (HFA) [ Time Frame: assessed annually ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Total point score for the 30-2 program of the Humphrey Field analyzer (HFA)

Change History

Complete list of historical versions of study NCT00346333 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Computer-averaged 30-Hz cone ERG amplitudes [ Time Frame: assessed annually ] [ Designated as safety issue: No ]
Visual acuity [ Time Frame: assessed annually ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Computer-averaged 30-Hz cone ERG amplitudes
Visual acuity

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Randomized Clinical Trial for Retinitis Pigmentosa

Official Title ^ICMJE

Randomized Clinical Trial for Retinitis Pigmentosa

Brief Summary

The purpose of this trial is to determine whether a nutritional supplement in addition to vitamin A will slow the course of retinitis pigmentosa.

Detailed Description

Retinitis pigmentosa (RP) is a group of inherited retinal degenerations with a worldwide prevalence of approximately 1 in 4,000. Patients typically report night blindness and difficulty with midperipheral visual field in adolescence. As the condition progresses, they lose far peripheral visual field. Most patients have reductions in central vision by age 50 to 80 years.

The study is a randomized, controlled, double-masked trial with a planned duration of 5 years. Patients with the common forms of RP are assigned to either a test or a control group. All receive 15,000 IU/day of vitamin A palmitate in addition to the supplement under study. Participants will not know the contents of the supplement or the group to which they have been assigned until the end of the trial. The main outcome measurement is the total point score for the 30-2 program of the Humphrey Field analyzer (HFA). In addition, computer-averaged 30-Hz cone ERG amplitudes and visual acuity are measured annually.

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

Retinitis Pigmentosa
Inherited Retinal Degeneration

Intervention ^ICMJE

Dietary Supplement: Nutritional supplement
daily dose of nutritional supplement
Dietary Supplement: Vitamin A palmitate
15,000 IU/day of vitamin A palmitate unless indication of toxicity

Study Arm (s)

Not Provided

Publications *

Berson EL, Rosner B, Sandberg MA, Weigel-DiFranco C, Brockhurst RJ, Hayes KC, Johnson EJ, Anderson EJ, Johnson CA, Gaudio AR, Willett WC, Schaefer EJ. Clinical trial of lutein in patients with retinitis pigmentosa receiving vitamin A. Arch Ophthalmol. 2010 Apr;128(4):403-11.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Enrollment ^ICMJE

241

Estimated Completion Date

December 2008

Estimated Primary Completion Date

December 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Have typical retinitis pigmentosa (RP)
Be between the ages of 18 and 60
Be able to see the entire face of someone sitting across the table from them without scanning
Read newspaper-size print without special magnifying aids
Walk unaided in daylight
Hear on the telephone
Have a normal fasting serum vitamin A and normal liver function profile
Be a non-smoker
Eat a balanced diet
Be in good general health
Reside in the United States

Exclusion Criteria:

Women who are pregnant or planning to become pregnant (Vitamin A supplements can increase the risk of birth defects.)
Current participation in another clinical trial for RP

Gender

Both

Ages

18 Years to 60 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Not Provided

Administrative Information

NCT Number ^ICMJE

NCT00346333

Other Study ID Numbers ^ICMJE

NEI-126

Has Data Monitoring Committee

Yes

Responsible Party

Eliot L. Berson, M.D., Harvard Medical School

Study Sponsor ^ICMJE

National Eye Institute (NEI)

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Chair:

Eliot Berson, MD

Harvard Medical School

Information Provided By

National Eye Institute (NEI)

Verification Date

December 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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