Status:
COMPLETED
Efficacy and Safety of Oral Valproic Acid for Retinitis Pigmentosa
Lead Sponsor:
Seoul National University Hospital
Conditions:
Retinitis Pigmentosa
Retinal Diseases
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of oral valproic acid to slow the progression of visual function and/or to improve the visual function in patients with retinitis pigme...
Detailed Description
This study is designed as a single-site, interventional, prospective, non-randomized, controlled study of 200 participants. Patients that participate in the study will be assigned to either valproic a...
Eligibility Criteria
Inclusion
- Diagnosis of retinitis pigmentosa (RP) established by night blindness, visual field constriction, marked reduction of electroretinogram, and the clinical signs of RP in fundus examination
- Best corrected visual acuity of 20/200 or more on a Snellen chart in at least one eye
- Intact visual field of 5 or more as measured by the kinetic perimetry
- Understand and sign the IRB-approved informed consent document for the study
- Body weight: male (40 kg to 100 kg), female (40 kg to 80 kg)
- Must be able to swallow tablets
- Female subjects of childbearing potential must commit to practice acceptable methods of contraception
Exclusion
- Pregnant women
- Lactating mothers
- Medical problems that make consistent follow-up over the treatment period unlikely (e.g., stroke, myocardiac infarction, malignancy) or severe systemic disease
- Other ocular disease: retinal disease other than RP or cystoid macular edema, glaucoma, cataract worse than +2PSC or infectious corneal disease
- Coagulation disorder or bleeding-tendency
- Liver dysfunction
- Renal dysfunction
- History of pancreatitis
- History of neurological disorders including epilepsy, history of brain injury or any organic brain disorders
- History of mental disorders including schizophrenia, bipolar disorder, or suicidality
- Currently receiving valproic acid or other anti-convulsants
- Has taken one of the following drugs at least 4 weeks prior to enrollment as these drugs are specifically known to affect the progression of RP: vitamin A, lutein, omega-3 fatty acid, or any antioxidant which affect the blood flow of retina or retinal function.
Key Trial Info
Start Date :
March 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2015
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT01399515
Start Date
March 1 2011
End Date
November 1 2015
Last Update
April 14 2016
Active Locations (1)
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1
Department of Ophthalmology, Seoul National University Hospital
Seoul, South Korea, 110-744