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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Valproic acid | Active Comparator |
| |
| Control | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Valproic Acid | Drug | One 500mg tablet by mouth daily |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, week 24, and week 48 |
| Measure | Description | Time Frame |
|---|---|---|
| Mean change in best corrected visual acuity (BCVA) | BCVA as measured by Early Treatment Diabetic Retinopathy Study (ETDRS) | Baseline, week 24, and week 48 |
| Mean change in 30-Hz flicker Electroretinogram (ERG) amplitude |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hyeong Gon Yu, MD, PhD | Department of Ophthalmology, Seoul National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Ophthalmology, Seoul National University Hospital | Seoul | 110-744 | South Korea |
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| ID | Term |
|---|---|
| D012174 | Retinitis Pigmentosa |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
| D015785 | Eye Diseases, Hereditary |
| D012162 | Retinal Degeneration |
| ID | Term |
|---|---|
| D058499 | Retinal Dystrophies |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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| ID | Term |
|---|---|
| D014635 | Valproic Acid |
| ID | Term |
|---|---|
| D010421 | Pentanoic Acids |
| D014631 | Valerates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
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| Baseline and week 48 |
| Mean change in central macular thickness | Central macular thickness as measured by Optical Coherence Tomography (OCT) | Baseline, week 24, and week 48 |
| Mean change in fundus appearance | Fundus appearance as judged by color fundus photography | 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) | Baseline and week 48 |
| Occurrence of adverse effect related to Valproic acid | 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) | Baseline through 48 weeks |
| Mean change in central macular volume | Central macular volume as measured by Optical Coherence Tomography (OCT) | Baseline, week 24, and week 48 |
| D009930 |
| Organic Chemicals |
| D005232 | Fatty Acids, Volatile |
| D005227 | Fatty Acids |
| D008055 | Lipids |