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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01600300
Recruitment Status : Completed
First Posted : May 17, 2012
Last Update Posted : May 17, 2012
Information provided by (Responsible Party):
Acuity Medical International, Inc.

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.

Condition or disease Intervention/treatment Phase
Macular Degeneration Device: Tesmac Device: Sham Tesmac device Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double-Blind, Placebo-Controlled Feasibility Study to Evaluate the Efficacy of TESMAC™ (Transcutaneous Electrical Stimulation of the Macula)
Study Start Date : August 2002
Actual Primary Completion Date : April 2004
Actual Study Completion Date : April 2004

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Placebo Comparator: Sham
Treatment with inactivate Tesmac device
Device: Sham Tesmac device
Treatment with inactivated Tesmac device on the same schedule as the group treated with the active Tesmac device.

Active Comparator: Tesmac
Treatment with active Tesmac device
Device: Tesmac
Subjects were treated twice daily for five consecutive days, followed by two days untreated, and then treated twice daily for five more consecutive days.
Other Name: Theramac

Primary Outcome Measures :
  1. Change in visual acuity [ Time Frame: Day 5, Day 12 ]
    Change in visual acuity as measured with ETDRS eye chart

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. 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.
  2. 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.
  3. Both sexes are eligible.
  4. The best-corrected visual acuity can be no better than 20/40 and no worse than 20/100 in the treated eyes.
  5. Age greater than 50.
  6. 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.
  7. 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:

  1. Subjects with seizure disorders.
  2. Subjects with additional eye-related diseases that have associated ongoing retinal bleeding.
  3. Subjects with any implanted electrical device.
  4. Subjects who have smoked, on average, more than half a pack of cigarettes per day during the last 5 years.
  5. Subjects with known allergy to contrast dye.
  6. 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.
  7. 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.
  8. Subjects unwilling to adhere to visit or examination schedules as described in the study protocol.
  9. 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.
  10. Any subject experiencing an acute stressor that, in the opinion of the investigator, might affect the course or treatment of AMD.
  11. Anyone with diagnosis of malignant or poorly controlled glaucoma in the eye(s) that would be treated.
  12. Anyone with diabetic retinopathy.
  13. Anyone with a progressive corneal dystrophy in the eye(s) that would be treated.
  14. Anyone with any noted chorio retinal disease (other than AMD) in the eye(s) that would be treated.
  15. 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.
  16. Subjects participating in an AMD natural history study.
  17. Subjects with one eye diagnosed with wet AMD.
  18. Subjects with any previous retinal bleeding, injury, or retinal surgery.
  19. Subjects that have previously been diagnosed with amblyopia.
  20. Subjects currently taking blood-thinning medication.
  21. Subjects cannot have previously been involved in a TESMAC™ study.
  22. 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01600300

Sponsors and Collaborators
Acuity Medical International, Inc.
Principal Investigator: Richard Beauchemin, MD WNC Eye Care Associates PA

Responsible Party: Acuity Medical International, Inc. Identifier: NCT01600300     History of Changes
Other Study ID Numbers: TESMAC-2002.2
First Posted: May 17, 2012    Key Record Dates
Last Update Posted: May 17, 2012
Last Verified: May 2012

Keywords provided by Acuity Medical International, Inc.:
Age-related macular degeneration
electrical stimulation
double blind

Additional relevant MeSH terms:
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases