Trial of Oral Valproic Acid for Retinitis Pigmentosa (NCT01233609) | Clinical Trial Compass
CompletedPhase 2
Trial of Oral Valproic Acid for Retinitis Pigmentosa
United States90 participantsStarted 2010-11
Plain-language summary
The objectives of this study are to evaluate the efficacy of Valproic Acid (VPA) to both slow the progression of visual function loss and/or to restore visual function in patients with Autosomal Dominant Retinitis Pigmentosa (RP) and to collect safety and tolerability information.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Understand/sign the IRB-approved study informed consent document.
✓. Age greater than or equal to 18 years, no upper age limit
✓. Males and non-child bearing females must weigh ≥40 Kg and ≤158.9 Kg; Females of child bearing potential must weigh ≥40 Kg and ≤74.9 Kg.
✓. Diagnosis of Retinitis Pigmentosa (RP).
✓. Visual acuity of greater than or equal to 35 letters in at least one eye as measured by the EVA-ETDRS (equivalent to 20/200 on a Snellen chart).
✓. Genotyped as autosomal dominant form of RP.
✓. Female subjects of childbearing potential and male subjects able to father children must have (or have a partner who has) had a hysterectomy or vasectomy, be completely abstinent from intercourse or must commit to practice at least two acceptable methods of contraception to minimize the chance of pregnancy during the study and for the 13 week period after stopping the study drug.
✓. Female subjects of childbearing potential must have a negative urine pregnancy test at study entry and throughout the duration of the study.
Exclusion criteria
✕. Medical problems that make consistent follow-up over the treatment period unlikely (e.g. stroke, severe MI, end stage malignancy), or in general a poor medical risk because of other systemic diseases or active uncontrolled infections.
✕. Other retinal diseases: Glaucoma, retinal inflammatory disease (CME is allowable), cataract worse than +2 NS, or herpes simplex virus of the eye.
What they're measuring
1
Mean Change in Visual Field Area From Baseline to 52 Weeks--III4e Isopter
✕. Subject unable to provide reliable perimetry measurements in both eyes for both static and kinetic visual field, as determined by the Reading Center.
✕. Diabetes.
✕. History of cancer (other than non-melanoma skin cancer) diagnosed, or requiring treatment within the past 2 years.
✕. A hemoglobin concentration, a platelet count or an absolute neutrophil count below the lower limit of normal at study entry.
✕. Suspected liver dysfunction determined by having liver function values elevated above the upper limit of normal.