A Phase 2 interventional study of Valproic Acid in Retinitis Pigmentosa, Retinal Diseases and Eye Diseases, sponsored by Seoul National University Hospital. Completed at 1 site in Korea, Republic of. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-04-14.
Sponsored by Seoul National University Hospital · Phase 2, Interventional, and Treatment
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 pigmentosa (RP).
Enrolled subjects in valproic acid group will be treated with oral valproic acid 500mg daily for 48 weeks. Visual function and safety will be assess before and after treatment (48 weeks) between valproic acid and control groups.
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 acid group or control in a 3:1 ratio.
740 studies on the registry are indexed under Eye Diseases; 117 are open to participants now.
This study's enrollment of 200 is above the median of 68 across 547 interventional studies indexed under Eye Diseases.
Browse Eye Diseases studies →Seoul National University Hospital is the lead sponsor of 1,860 studies on the registry; 275 are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 2 (17%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: Valproic Acid
One 500mg tablet by mouth daily
Also known as: Valproate
Mean change in visual field area from baseline to 48 weeks
Visual field area will be measured using kinetic perimetry (Goldmann perimetry) or static perimetry including the central 30 field.
Time frame: Baseline, week 24, and week 48
Mean change in best corrected visual acuity (BCVA)
BCVA as measured by Early Treatment Diabetic Retinopathy Study (ETDRS)
Time frame: Baseline, week 24, and week 48
Mean change in 30-Hz flicker Electroretinogram (ERG) amplitude
Time frame: Baseline and week 48
Mean change in central macular thickness
Central macular thickness as measured by Optical Coherence Tomography (OCT)
Time frame: Baseline, week 24, and week 48
Mean change in fundus appearance
Fundus appearance as judged by color fundus photography
Time frame: Baseline and week 48
Mean change in total score on vision-related quality of life
Total score on vision-related quality of life as measured by the National Eye Institute Visual Function Questionnaire (NEI-VFQ25)
Time frame: Baseline and week 48
Occurrence of adverse effect related to Valproic acid
Time frame: Baseline through 48 weeks
Changes in clinical laboratory data
CBC, BUN, Creatinine, Liver panel (Cholesterol, Total protein, Albumin, Total bilirubin, Alkaline phosphatase, AST, ALT, GGT), Coagulation panel (PT INR, PT%, PT sec, aPTT, Fibrinogen), Electrolyte panel (Na, K, Cl, TCO2)
Time frame: Baseline through 48 weeks
Mean change in central macular volume
Central macular volume as measured by Optical Coherence Tomography (OCT)
Time frame: Baseline, week 24, and week 48
This study is completed, as verified in Apr 2016. You cannot join it, but the record below documents what was studied.
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Seoul National University Hospital