Efficacy of Electrical Micro-current Retinal Stimulation for Treatment of Dry Age-related Macular Degeneration

Study Overview
=================
Brief Summary
-----------------
Hypothesis: external electrical stimulation of the retina with low level electrical currents improves visual acuity in subjects with age-related dry macular degeneration.

Official Title
-----------------
A Double-Blind, Placebo-Controlled Feasibility Study to Evaluate the Efficacy of TESMAC™ (Transcutaneous Electrical Stimulation of the Macula)

Conditions
-----------------
Macular Degeneration

Intervention / Treatment
-----------------
* Device: Tesmac
* Device: Sham Tesmac device


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of Macular Degeneration, i.e., at least three, hard or soft drusen must be present there must be RPE changes (migration, clumping or atrophy) within the central 6mm of the retina. As a prerequisite for entry into the study, all patients will have their diagnosis of dry AMD confirmed by an ophthalmologist via a retinal exam and Fluorescein Angiography will also determine whether or not the subject is a candidate for laser surgery. Only subjects who have AMD will be admitted to the study. Both sexes are eligible. The best-corrected visual acuity can be no better than 20/40 and no worse than 20/100 in the treated eyes. Age greater than 50. Subjects must be highly motivated, alert, oriented, mentally competent and able to understand and comply with the requirements of the study, abide by the restrictions, return for all required visits, and provide voluntary informed consent. Both eyes of the subject must show no evidence of wet AMD. If one eye is wet and the fellow eye is dry, the subject will be excluded. Exclusion Criteria: Subjects with seizure disorders. Subjects with additional eye-related diseases that have associated ongoing retinal bleeding. Subjects with any implanted electrical device. Subjects who have smoked, on average, more than half a pack of cigarettes per day during the last 5 years. Subjects with known allergy to contrast dye. Subjects who are in poor general health, have unstable diseases, are terminally ill, have a life expectancy of less than 12 months, are non-ambulatory or bedridden, live in a geographical location which would likely prevent regular attendance at study visits or are considered not suitable for participation by the investigator. Subjects exposed to an investigational device or drug within the past 30 days or involved concurrently in other treatment clinical trials. Note: Subjects participating in studies investigating the natural progression of AMD may not participate in this trial. Subjects unwilling to adhere to visit or examination schedules as described in the study protocol. Subjects with a known history of alcoholism, drug abuse, psychosis, clinical evidence of depression, poor motivation, emotional or intellectual problems, or any other conditions which would likely limit validity of consent or appropriate responses to participate in the study or who are deemed unsuitable psychologically or physiologically for study participation by the investigator. Any subject experiencing an acute stressor that, in the opinion of the investigator, might affect the course or treatment of AMD. Anyone with diagnosis of malignant or poorly controlled glaucoma in the eye(s) that would be treated. Anyone with diabetic retinopathy. Anyone with a progressive corneal dystrophy in the eye(s) that would be treated. Anyone with any noted chorio retinal disease (other than AMD) in the eye(s) that would be treated. Anyone with a progressive nuclear cataract in the eye(s) that would be treated. Stable cortical cataract patients may be included. Any patient with an immature cataract, one in which scattered opacities are separated by clear zones, may be included in the study. All patients with mature, hypermature or morgagnian cataracts in the eye(s) that would be treated will be excluded. Patients with a grade 3 or grade 4 cataract in the eye(s) that would be treated will be excluded. Grade 1 and Grade 2 cataract patients may be included in this study. Subjects participating in an AMD natural history study. Subjects with one eye diagnosed with wet AMD. Subjects with any previous retinal bleeding, injury, or retinal surgery. Subjects that have previously been diagnosed with amblyopia. Subjects currently taking blood-thinning medication. Subjects cannot have previously been involved in a TESMAC™ study. Subjects that take two or more of the following antioxidants daily at the following doses: 500 milligrams of vitamin C; 400 international units of vitamin E; 15 milligrams of beta-carotene; 80 milligrams of zinc as zinc oxide; and two milligrams of copper as cupric oxide and have done this for more than 2 years. These subjects may be included, but their study results will be analyzed separately.

Ages Eligible for Study
-----------------
Minimum Age: 50 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Sham<br>Treatment with inactivate Tesmac device | Device: Sham Tesmac device<br>* Treatment with inactivated Tesmac device on the same schedule as the group treated with the active Tesmac device.<br>|
| Active Comparator: Tesmac<br>Treatment with active Tesmac device | Device: Tesmac<br>* Subjects were treated twice daily for five consecutive days, followed by two days untreated, and then treated twice daily for five more consecutive days.<br>* Other names: Theramac;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in visual acuity | Change in visual acuity as measured with ETDRS eye chart | Day 5, Day 12 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Age-related macular degeneration, electrical stimulation, randomized, double blind