Transcorneal Electrical Stimulation for the Treatment of Retinitis Pigmentosa - a Safety and Efficacy Multicenter Study

Withdrawn before enrolling · Not applicable · Has a placebo group

Conditions studied: Retinitis Pigmentosa

In brief

Several studies have shown that TES in RP patients may help to slow the progressive deterioration of this degenerative disease. The end point of this clinical trial is to slow or stop disease progression with weekly treatment using TES for 1 year.

Key facts

Study ID

NCT02548572

Run by

Wills Eye

People needed

0

Starts

2019-01-01

Expected to finish

2020-12-01

Last updated by the study team

2019-05-01

Who can join

Age: 22 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients with Retinitis Pigmentosa.
• Adult patients, 22-80 years of age, having provided written informed consent and HIPAA authorization.
• LogMAR VA 1.00 or better in both eyes.
• Octopus 900 Central Visual Field ≥10 degrees diameter around central fixation using stimulus sizes III4e and V4e in both eyes on kinetic testing.
• Agree to discontinue Vitamin A use and no intake for at least 2 months prior to baseline visit.

You may not qualify if…

• Visual field loss as demonstrated by Octopus 900 kinetic perimetry as <10 deg of remaining central visual field using stimulus sizes III4e and V4e.
• Due to distance or other reason, patients unable to travel to Philadelphia or respective centers for the treatment procedures and follow-up examinations.
• Diabetic retinopathy
• Ocular neovascularisation of any origin
• After arterial or venous occlusion
• After retinal detachment or any vitreoretinal surgery with or without implantation.
• Silicone oil tamponade
• Dry or exudative age-related macular degeneration
• Macular edema involving the foveal center as determined by SD-OCT
• All forms of glaucoma
• Any form of corneal degeneration that reduces visual acuity
• Systemic diseases that are difficult to control or manage, which could hinder regular attendance at follow-up examinations
• Patients in a permanently poor general condition, which could hinder regular attendance at follow-up examinations
• Patients in whom phosphenes are only inducible at greater than, but not including, 0.8 mA.
• Forms of mental illness related to the bipolar affective and schizoid-affective disorders, epilepsy, and all forms of dementia
• Simultaneous participation in another interventional study or history of interventions whose effect may still persist
• Current pregnancy, or being a woman with childbearing potential who is unwilling to use medically acceptable means of birth control for the study duration, or a woman unwilling to perform a pregnancy test at study entry
• Any patient can be excluded from the study as determined by the Principal Investigator.

Where it is running

• Wills Eye Health System — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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