Randomized Trial for Retinitis Pigmentosa

Randomized Trial for Retinitis Pigmentosa



Sponsors


Source

National Eye Institute (NEI)

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. Based on electroretinograms (ERGs), the course of the disease can be slowed on
average among adults on 15,000 IU/day of vitamin A palmitate. While conducting the trial on
the effects of vitamin A on RP, it became apparent that another substance in the diet could
be affecting the course of the disease. This prompted the present randomized, controlled
trial.

This 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 capsules 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 on the Humphrey Field Analyzer (HFA). In addition, computer-averaged 30-Hz cone ERG
amplitudes and visual acuity are measured annually.

Overall Status

Completed

Start Date

1996-05-01

Completion Date

1997-09-01

Primary Completion Date

N/A

Phase

Phase 3

Study Type

Interventional


Condition


Intervention

Intervention Type

Drug

Intervention Name



Intervention Type

Drug

Intervention Name




Eligibility

Criteria

Inclusion Criteria:

Eligible patients must:

- Be between the ages of 18 and 56

- 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

- Have a normal fasting serum vitamin A and normal liver function profile

- Be in good general health

- Reside in the United States

Exclusion Criteria:

- Women who are pregnant or planning to become pregnant cannot be included because of
the risk of birth defects that could occur while they are on a vitamin A supplement.

Gender

All

Minimum Age

18 Years

Maximum Age

56 Years


Overall Official

Last Name

Role

Affiliation

Eliot Berson, MD
Study Chair
Berman-Gund Laboratory for the Study of Retinal Degenerations, Harvard Medical School

Location

Facility

Berman-Gund Laboratory for the Study of Retinal Degenerations, Harvard Medical School, Massachusetts Eye and Ear Infirmary
Boston Massachusetts 02114 United States

Location Countries

Country

United States


Verification Date

2009-09-01

Lastchanged Date

N/A

Firstreceived Date

N/A

Has Expanded Access

No

Condition Browse


Intervention Browse

Mesh Term

Vitamin A


Results Reference

Citation

Berson EL, Rosner B, Sandberg MA, Weigel-DiFranco C, Moser A, Brockhurst RJ, Hayes KC, Johnson CA, Anderson EJ, Gaudio AR, Willett WC, Schaefer EJ. Clinical trial of docosahexaenoic acid in patients with retinitis pigmentosa receiving vitamin A treatment. Arch Ophthalmol. 2004 Sep;122(9):1297-305.

PMID

15364708


Citation

Berson EL, Rosner B, Sandberg MA, Weigel-DiFranco C, Moser A, Brockhurst RJ, Hayes KC, Johnson CA, Anderson EJ, Gaudio AR, Willett WC, Schaefer EJ. Further evaluation of docosahexaenoic acid in patients with retinitis pigmentosa receiving vitamin A treatment: subgroup analyses. Arch Ophthalmol. 2004 Sep;122(9):1306-14.

PMID

15364709



Firstreceived Results Date

N/A

Firstreceived Results Disposition Date

N/A

Study Design Info

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary Purpose

Treatment

Masking

Double


Study First Submitted

September 23, 1999

Study First Submitted Qc

September 23, 1999

Study First Posted

September 24, 1999

Last Update Submitted

September 16, 2009

Last Update Submitted Qc

September 16, 2009

Last Update Posted

September 17, 2009


ClinicalTrials.gov processed this data on August 24, 2018

Conditions

Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov, conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions

Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied. Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase

Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions that study is seeking to answer:

In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.

In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.

In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.

In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.

These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.



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