Valproic Acid Clinical Trial for RP Expanding to Boost Participant Enrollment

February 23, 2012
Image of researcher looking into a microscopeThe Foundation Fighting Blindness is adding four new sites to its Phase II clinical trial of valproic acid for the treatment of autosomal dominant retinitis pigmentosa (adRP). The goal of the expansion is to accelerate and increase patient enrollment.

“By adding more clinical trial sites, we can speed up and expand our recruitment of participants, which will help ensure that we meet our overall timelines and milestones,” says Dr. Patricia Zilliox, chief drug development officer, Foundation Fighting Blindness. “The four new sites have large numbers of potential trial candidates, as well as the expertise and resources to conduct the study well.”

The sites are: Bascom Palmer Eye Institute at the University of Miami and the Hamilton Eye Institute at the University of Tennessee in Memphis, which plan to begin participant enrollment next month; and the University of Michigan and Oregon Health & Science University, which will start enrolling participants in June.

The three-year, 90-person study began last year at the University of Utah in Salt Lake City and the Retina Foundation of the Southwest in Dallas. These sites continue to screen and enroll participants.

For more information on enrollment or to contact a study center, visit the valproic acid clinical trial listing on the Foundation’s website.

Researchers believe that valproic acid may slow vision loss by overcoming defects in vision-critical proteins that typically cause adRP. Investigators also believe that the drug may have anti-oxidative and anti-inflammatory properties, which may help preserve vision, as well.

In a paper published in the British Journal of Ophthalmology on July 20, 2010, researchers reported encouraging results in an evaluation of valproic acid in seven patients. Subsequent lab studies funded by the Foundation also showed that valproic acid slowed vision loss in mice with adRP.

However, Foundation-funded lab studies showed that the drug did not slow vision loss in mice with autosomal recessive RP.

Valproic acid has already received FDA approval for the treatment of epilepsy, so the drug can potentially go through a quicker and less costly clinical trial process than would be possible if it were an unapproved, untested compound.