Retinitis Pigmentosa Clinical Trial
Official title:
Randomized Clinical Trial for Retinitis Pigmentosa
The purpose of this trial is to determine whether lutein in addition to vitamin A will slow the course of retinitis pigmentosa.
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 mid-peripheral visual field in adolescence. As the condition progresses,
they lose far peripheral visual field. Most patients have reductions in central vision by 60
years if left untreated. Vitamin A palmitate, 15,000 International Units (IU)/d and an
omega-3 rich diet have been shown to slow the progression of this condition among adults
with the typical forms.(see Archives of Ophthalmology,111:761-772,1993 ; Archives of
Ophthalmology 122: 1306-1314, 2004; Archives of Ophthalmology 130(6):701-711,2013).
The present study was a randomized, controlled, double-masked trial with a planned duration
of 5 years.Two hundred and forty adults with the typical forms of RP were assigned to either
lutein 12mg/d or a control group. Patients in both groups received 15,000 IU/day of vitamin
A palmitate in addition to the supplement under study. Participants agreed not to know the
contents of the supplement or their group assignment until the end of the trial. The main
outcome measurement was the total point score for the 30-2 program of the Humphrey Field
analyzer (HFA). In addition,the total point score for the 60-4 program ,the total point
score of the 30-2 and 60-4 programs combined, computer-averaged 30-Hz cone Electroretinogram
(ERG) amplitude and Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity were
measured annually as secondary endpoints.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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