Macular DegenerationPhase 1/2NCT01600300
Efficacy of Electrical Micro-current Retinal Stimulation for Treatment of Dry Age-related Macular Degeneration
A Phase 1/2 study testing Tesmac in people with Macular Degeneration, run by Acuity Medical International, Inc..
Trial summary
Hypothesis: external electrical stimulation of the retina with low level electrical currents improves visual acuity in subjects with age-related dry macular degeneration. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Macular Degeneration
- What is being tested?
- Tesmac
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Aug 2002to Apr 2004
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
About this study
Official title: A Double-Blind, Placebo-Controlled Feasibility Study to Evaluate the Efficacy of TESMAC™ (Transcutaneous Electrical Stimulation of the Macula)
Hypothesis: external electrical stimulation of the retina with low level electrical currents improves visual acuity in subjects with age-related dry macular degeneration.
- Conditions
- Macular Degeneration
- Being tested
- Tesmac, Sham Tesmac device
- Keywords
- Age-related macular degeneration, electrical stimulation, randomized, double blind
- Medical subject headings
- Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TesmacDevice
Also called Theramac
Subjects were treated twice daily for five consecutive days, followed by two days untreated, and then treated twice daily for five more consecutive days.
Sham Tesmac deviceDevice
Treatment with inactivated Tesmac device on the same schedule as the group treated with the active Tesmac device.
| Study group | Role | What they receive |
|---|---|---|
| Sham | Placebo comparator | Treatment with inactivate Tesmac device Receives: Device: Sham Tesmac device |
| Tesmac | Active comparator | Treatment with active Tesmac device Receives: Device: Tesmac |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in visual acuity
Change in visual acuity as measured with ETDRS eye chart
Measured: Day 5, Day 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2012 (estimated)
- Study startAug 2002
- Primary completionApr 2004
- Study completionApr 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Macular DegenerationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Acuity Medical International, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Richard Beauchemin, MD, Principal investigator, WNC Eye Care Associates PA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01600300
- Sponsor's protocol ID
- TESMAC-2002.2
- Status last verified
- May 2012
- First submitted
- 14 May 2012
- Last updated
- 17 May 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Placebo-Controlled Feasibility Study to Evaluate the Efficacy of TESMAC™ (Transcutaneous Electrical Stimulation of the Macula)
- ClinicalTrials.gov ID
- NCT01600300
- Acronym / sponsor ID
- TESMAC-2002.2
- Conditions
- Macular Degeneration
- Keywords
- Age-related macular degeneration, electrical stimulation, randomized, double blind
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Acuity Medical International, Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2002
- Primary completion
- Apr 2004 (actual)
- Study completion
- Apr 2004 (actual)
- First posted
- 17 May 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Hypothesis: external electrical stimulation of the retina with low level electrical currents improves visual acuity in subjects with age-related dry macular degeneration.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sham | Placebo comparator | Device: Sham Tesmac deviceTreatment with inactivate Tesmac device |
| Tesmac | Active comparator | Device: TesmacTreatment with active Tesmac device |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (22 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TesmacAlso: TheramacSubjects were treated twice daily for five consecutive days, followed by two days untreated, and then treated twice daily for five more consecutive days. | Device | Tesmac |
| Sham Tesmac deviceTreatment with inactivated Tesmac device on the same schedule as the group treated with the active Tesmac device. | Device | Sham |
Primary outcome
Change in visual acuity
Time frame: Day 5, Day 12
Change in visual acuity as measured with ETDRS eye chart
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard Beauchemin, MD principal investigator
WNC Eye Care Associates PA
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Tesmac in people with Macular Degeneration, run by Acuity Medical International, Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 May 2012. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in visual acuity (time frame: Day 5, Day 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2012.