Randomized Clinical Trial for Retinitis Pigmentosa - Full Text View

Sponsored by:	National Eye Institute (NEI)
Information provided by:	National Eye Institute (NEI)
ClinicalTrials.gov Identifier:	NCT00346333

Purpose

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

Condition	Intervention	Phase
Retinitis Pigmentosa Inherited Retinal Degeneration	Dietary Supplement: Nutritional supplement Dietary Supplement: Vitamin A palmitate	Phase II

Genetics Home Reference related topics: Lenz microphthalmia syndrome oculofaciocardiodental syndrome Peters plus syndrome X-linked juvenile retinoschisis

MedlinePlus related topics: Dietary Supplements

Drug Information available for: Vitamin A Retinol

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Randomized Clinical Trial for Retinitis Pigmentosa

Further study details as provided by National Eye Institute (NEI):

Primary Outcome Measures:

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

Secondary Outcome Measures:

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 ]

Enrollment:	241
Study Start Date:	August 2003
Estimated Study Completion Date:	December 2008
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Intervention Details:

daily dose of nutritional supplement

15,000 IU/day of vitamin A palmitate unless indication of toxicity

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.

Eligibility

Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00346333

Sponsors and Collaborators

National Eye Institute (NEI)

Investigators

Study Chair:

Eliot Berson, MD

Harvard University

More Information

NEI Clinical Studies Database This link exits the ClinicalTrials.gov site

Responsible Party:	Harvard Medical School ( Eliot L. Berson, M.D. )
Study ID Numbers:	NEI-126
Study First Received:	June 27, 2006
Last Updated:	December 21, 2007
ClinicalTrials.gov Identifier:	NCT00346333
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Pigmentary retinopathy
Retinol palmitate
Genetic Diseases, Inborn
Vitamin A
Eye Diseases
Cone rod dystrophy

Retinitis Pigmentosa
Retinitis
Eye Diseases, Hereditary
Retinal Degeneration
Retinal Diseases
Retinal degeneration

Additional relevant MeSH terms:

Anticarcinogenic Agents
Antioxidants
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses
Growth Substances

Vitamins
Physiological Effects of Drugs
Micronutrients
Protective Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009