Clinical Trial: Clinical Trial of Lutein for Patients With Retinitis Pigmentosa Receiving Vitamin A

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Randomized Clinical Trial for Retinitis Pigmentosa

Brief Summary: The purpose of this trial is to determine whether lutein in addition to vitamin A will slow the course of retinitis pigmentosa.

Detailed Summary:

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.


Sponsor: National Eye Institute (NEI)

Current Primary Outcome: Central Visual Field (vf) Change Assessed Using the 30-2 Program of the Humphrey Field Analyzer (HFA). [ Time Frame: assessed at each of 4 annual visits after baseline ]

Sum of visual field sensitivity readings in decibel(dB) to a size V target out to the 30 degree meridian in each direction of the visual field. The value presented represents annual change in dB over 4 years.


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

Current Secondary Outcome:

  • Mid-peripheral Field Change Assessed With the 60-4 Program of the Humphrey Field Analyzer. [ Time Frame: assessed at each of 4 annual visits after baseline ]
    Sum of visual field sensitivity readings in dB to a size V target from the 30 degree meridian to the 60 degree meridian in each direction of the visual field. The value presented represents annual change in dB over 4 years.
  • Total Field Change Assessed by the Combined 30-2 and 60-4 Programs of the Humphrey Field Analyzer. [ Time Frame: assessed at each of 4 annual visits after baseline ]
    Sum of visual field sensitivity readings in dB to a size V target obtained with the 30-2 and 60-4 programs of the Humphrey Field Analyzer combined for those patients on whom both measures were available.
  • Annual Change in 30 Hertz(Hz)Electroretinogram(ERG )Amplitude in Natural Log (ln) Microvolts/yr Over a 4 Year Period. [ Time Frame: assessed at each of 4 annual visits after baseline ]
    Computer averaged 30 Hz ERG amplitudes in microvolts for those with initial amplitudes of >= 0.68 microvolts. Presented on the ln scale.
  • Early Treatment Diabetic Retinopathy Study (ETDRS) Visual Acuity [ Time Frame: assessed at each of 4 annual visits after baseline ]
    Annual change in number of letters read.


Original Secondary Outcome:

  • Computer-averaged 30-Hz cone ERG amplitudes
  • Visual acuity


Information By: National Eye Institute (NEI)

Dates:
Date Received: June 27, 2006
Date Started: July 2003
Date Completion:
Last Updated: December 12, 2013
Last Verified: December 2013