From The Retina Foundation of the Southwest
Located in Dallas, Texas

Investigation of Effectiveness and Safety of High Dose  Docosahexaenoic Acid (DHA) in X-Linked Retinitis Pigmentosa
 

The investigators of this Phase II Clinical Trial are: Dennis R. Hoffman, Ph.D. (principal investigator), David G. Birch, Ph.D., Dianna K.H. Wheaton, M.S., Gary E. Fish, M.D., and Rand Spencer, M.D.

The following is a brief description of the trial:

·        This clinical trial is designed to test whether a nutritional supplement will slow progression of the disease so that patients with X-linked RP will maintain vision for a longer period of time.

·        This is a controlled clinical trial which means that there is a 50-50 chance of receiving the experimental supplement or a placebo supplement.

·        Participants are asked to take the supplement daily for the entire 4-year duration of the trial. The number of capsules taken daily is based on your bodyweight.

·        Trial participants must meet entry criteria:

o       Males between the ages of 7 and 32 years.

o       A diagnosis of RP by an ophthalmologist or retinal specialist.

o       Verified pattern of X-linked inheritance.

o       Adequate visual function to complete 4-years of testing.

·        If qualified, all testing takes place at the Retina Foundation in Dallas, TX

·        Travel Expenses to the Retina Foundation in Dallas for each participant and a sighted companion will be covered by the funding agencies. Also included are taxis, room accommodations and an additional $200 incentive to ensure protocol compliance.

For further information, contact Dr. Dennis Hoffman at 214-363-3911 ext. 125 or dhoffman@retinafoundation.org.

A detailed description is posted on the U.S. government’s ClinicalTrials.gov website at http://clinicaltrials.gov/ct/show/NCT00100230?order=2. 

Researchers at the Retina Foundation of the Southwest in Dallas, TX are continuing to enroll participants into this trial co-sponsored by the U.S. Food & Drug Administration and the Foundation Fighting Blindness.
 

TARP is providing this notification for informational purposes only.  Any interested parties must make arrangements directly with Dr. Dennis Hoffman and the Retina Foundation of the Southwest who are responsible for the conduct of this research.  TARP makes no representations regarding the safety, efficacy or research results of the project.  If you choose to participate in this study, you should do so only after careful consideration on your part and without reliance in any way upon TARP.  You may consult your own physician in deciding whether to participate in the study.  TARP is not legally responsible for or to any person who decides to participate in the study.