Dry Macular DegenerationNCT02699216
BioCurrent Electrical Stimulation for the Treatment of Dry ARMD
A study testing Electrical Stimulation of the Retina in people with Dry Macular Degeneration, run by DuBois Vision Clinic.
Trial summary
This study evaluates the treatment of Dry Macular Degeneration and the resulting change in vision with a very, very low current that is similar to what occurs in the body naturally. In Phase 1, 16 participants will be treated, with half receiving treatment and half a sham (no treatment). Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dry Macular Degeneration
- What is being tested?
- Electrical Stimulation of the Retina
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jan 2016to Dec 2017
- Phase
- Interventional
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Best-corrected visual acuity can be no better than 20/40 and no worse than 20/200 for each enrolled eye
- Confirmed diagnosis of Dry MD
- Vision loss attributable to Dry MD
- 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
Who cannot join
- Any retinal pathology other than Dry MD
- Evidence or history of wet MD
- Previous intravitreal injection
- Seizure disorders
- Dense cataract
- Eyelid pathology at the treatment sites
Show all 12Show fewer
- Any prior electrical micro-stimulation treatment to the eyes
- Poor general health
- Active cancer
- Life expectancy less than 12 months
- Non-ambulatory
- Not considered suitable for participation for any other reason
About this study
Official title: BioCurrent Electrical Stimulation for the Treatment of Dry Age-Related Macular Degeneration
This study evaluates the treatment of Dry Macular Degeneration and the resulting change in vision with a very, very low current that is similar to what occurs in the body naturally. In Phase 1, 16 participants will be treated, with half receiving treatment and half a sham (no treatment). After the treatment period of one week, those not treated will be treated. In Phase 2, all participants will be treated.
Read the detailed description
The study will assess the effectiveness of transpalpebral micro-current electrical stimulation on improving the visual acuity in subjects with vision loss from Dry Macular Degeneration. The BioCurrent electrical stimulation will be applied by a device with the intended use of treating Dry Macular Degeneration. The device delivers a micro-current, an electrical current in the one millionth of an ampere range, to the retina in frequencies changing in a pre-defined pattern from 5Hz to 80Hz during each spot (40 sec). The device also incorporates a voltage limiter (a maximum of 245 micro A is possible) and a current level indicator. 200 micro A will be used. Very low electrical micro-current is delivered to the subject through the goggle probe.
- Conditions
- Dry Macular Degeneration
- Being tested
- Electrical Stimulation of the Retina
- Keywords
- Macular Degeneration, Eye Diseases, Retinal Degeneration, Retinal Diseases
- Medical subject headings
- Geographic Atrophy, Macular Degeneration, Eye Diseases, Retinal Degeneration, Retinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electrical Stimulation of the RetinaDevice
Transpalpebral micro-current electrical stimulation treatment for 3 consecutive days followed by a short wash-out period of 2 days.
| Study group | Role | What they receive |
|---|---|---|
| Phase 1 Active Treatment | Experimental | Subjects will undergo 8 treatments, approximately 11 minutes, to the enrolled eyes daily for three consecutive days, with an active device. They will receive no treatments on day 4 and 5. Receives: Device: Electrical Stimulation of the Retina |
| Phase 1 Sham Treatment | Placebo comparator | Subjects will undergo 8 sham treatments, approximately 11 minutes, with a non-functional device to the enrolled eyes daily for three consecutive days during week 1, with no treatments on day 4 and 5. Followed by 8 active treatments, for approximately 11 minutes, for three consecutive days, with an active device during week 2, with no treatments on day 4 and 5. Receives: Device: Electrical Stimulation of the Retina |
| Phase 2 Open Label | Experimental | Subjects will undergo 8 treatments, approximately 11 minutes, to the enrolled eyes daily for three consecutive days, with an active device. They will receive no treatments on day 4 and 5. Receives: Device: Electrical Stimulation of the Retina |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Best-corrected Visual Acuity using the Early Treatment of Diabetic Retinopathy Study (ETDRS) chart
Significant changes in ETDRS visual acuity; baseline and Day 5.
Measured: Baseline, Day 5
Secondary outcomes (1)
Changes in retinal sensitivity assessed by Microperimetry
Significant Changes in retinal sensitivity; baseline and Day 5.
Measured: Baseline, Day 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2016 (estimated)
- Study startJan 2016
- Primary completionOct 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- DuBois Vision Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02699216
- Sponsor's protocol ID
- WSW001
- Status last verified
- Jun 2018
- First submitted
- 16 Feb 2016
- Last updated
- 6 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BioCurrent Electrical Stimulation for the Treatment of Dry Age-Related Macular Degeneration
- ClinicalTrials.gov ID
- NCT02699216
- Acronym / sponsor ID
- WSW001
- Conditions
- Dry Macular Degeneration
- Keywords
- Macular Degeneration, Eye Diseases, Retinal Degeneration, Retinal Diseases
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- DuBois Vision ClinicUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Oct 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 4 Mar 2016 (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.
This study evaluates the treatment of Dry Macular Degeneration and the resulting change in vision with a very, very low current that is similar to what occurs in the body naturally. In Phase 1, 16 participants will be treated, with half receiving treatment and half a sham (no treatment). After the treatment period of one week, those not treated will be treated. In Phase 2, all participants will be treated.
Detailed description
The study will assess the effectiveness of transpalpebral micro-current electrical stimulation on improving the visual acuity in subjects with vision loss from Dry Macular Degeneration. The BioCurrent electrical stimulation will be applied by a device with the intended use of treating Dry Macular Degeneration. The device delivers a micro-current, an electrical current in the one millionth of an ampere range, to the retina in frequencies changing in a pre-defined pattern from 5Hz to 80Hz during each spot (40 sec). The device also incorporates a voltage limiter (a maximum of 245 micro A is possible) and a current level indicator. 200 micro A will be used. Very low electrical micro-current is delivered to the subject through the goggle probe.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Phase 1 Active Treatment | Experimental | Device: Electrical Stimulation of the RetinaSubjects will undergo 8 treatments, approximately 11 minutes, to the enrolled eyes daily for three consecutive days, with an active device. They will receive no treatments on day 4 and 5. |
| Phase 1 Sham Treatment | Placebo comparator | Device: Electrical Stimulation of the RetinaSubjects will undergo 8 sham treatments, approximately 11 minutes, with a non-functional device to the enrolled eyes daily for three consecutive days during week 1, with no treatments on day 4 and 5. Followed by 8 active treatments, for approximately 11 minutes, for three consecutive days, with an active device during week 2, with no treatments on day 4 and 5. |
| Phase 2 Open Label | Experimental | Device: Electrical Stimulation of the RetinaSubjects will undergo 8 treatments, approximately 11 minutes, to the enrolled eyes daily for three consecutive days, with an active device. They will receive no treatments on day 4 and 5. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Best-corrected visual acuity can be no better than 20/40 and no worse than 20/200 for each enrolled eye
- Confirmed diagnosis of Dry MD
- Vision loss attributable to Dry MD
- 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
Key exclusion criteria (12 listed)
- Any retinal pathology other than Dry MD
- Evidence or history of wet MD
- Previous intravitreal injection
- Seizure disorders
- Dense cataract
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 |
|---|---|---|
| Electrical Stimulation of the RetinaTranspalpebral micro-current electrical stimulation treatment for 3 consecutive days followed by a short wash-out period of 2 days. | Device | Phase 1 Active Treatment, Phase 1 Sham Treatment, Phase 2 Open Label |
Primary outcome
Change in Best-corrected Visual Acuity using the Early Treatment of Diabetic Retinopathy Study (ETDRS) chart
Time frame: Baseline, Day 5
Significant changes in ETDRS visual acuity; baseline and Day 5.
1 secondary outcome
Changes in retinal sensitivity assessed by Microperimetry
Time frame: Baseline, Day 5
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2018.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Electrical Stimulation of the Retina in people with Dry Macular Degeneration, run by DuBois Vision Clinic.
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 4 inclusion and 12 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: withdrawn, as of the sponsor's last update on 6 Jun 2018. 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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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 Best-corrected Visual Acuity using the Early Treatment of Diabetic Retinopathy Study (ETDRS) chart (time frame: Baseline, Day 5). 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 6 Jun 2018.