Dry Age-related Macular Degenerationi-SIGHTNCT04511936
Microcurrent Stimulation for Dry Age-related Macular Degeneration
A study testing i-Lumen AMD in people with Dry Age-related Macular Degeneration, run by i-Lumen Scientific, Inc..
Trial summary
Evaluate the safety and efficacy of microcurrent stimulation therapy for patients with dry age-related macular degeneration. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Dry Age-related Macular Degeneration
- What is being tested?
- i-Lumen AMD
- 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
- 1 Mar 2021to 31 Jan 2023
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Dry AMD diagnosis.
Who cannot join
- Wet AMD
About this study
Official title: Microcurrent Stimulation Therapy for Dry Age-related Macular Degeneration (i-SIGHT): a Multicenter, Randomized, Double-masked, Clinical Device Trial
Evaluate the safety and efficacy of microcurrent stimulation therapy for patients with dry age-related macular degeneration.
Read the detailed description
Multi-center, double-masked, randomized trial of microcurrent stimulation for the treatment of patients affected with dry age-related macular degeneration.
- Conditions
- Dry Age-related Macular Degeneration
- Being tested
- i-Lumen AMD, i-Lumen AMD Sham
- Keywords
- AMD, Dry AMD
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
i-Lumen AMDDevice
Microcurrent stimulator
i-Lumen AMD ShamDevice
Sham microcurrent stimulator
| Study group | Role | What they receive |
|---|---|---|
| i-Lumen AMD Active | Active comparator | Not described Receives: Device: i-Lumen AMD |
| i-Lumen AMD Sham | Sham comparator | Not described Receives: Device: i-Lumen AMD Sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change from baseline in best-corrected distance visual acuity (CDVA) at one month timepoint.
Measured: 1 Month
Secondary outcomes (1)
Best-corrected distance visual acuity (CDVA) response rate at 1 month visit.
Measured: 1 Month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2020
- Study start1 Mar 2021 (estimated)
- Primary completion31 Jan 2022 (estimated)
- Study completion31 Jan 2023 (estimated)
Why it stopped: COVID-related delays.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry Age-related 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- i-Lumen Scientific, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Timothy Jackson, MD, Principal investigator, King's College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04511936
- Sponsor's protocol ID
- ILS-AMD-101
- Acronym
- i-SIGHT
- Status last verified
- Apr 2021
- First submitted
- 11 Aug 2020
- Last updated
- 8 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microcurrent Stimulation Therapy for Dry Age-related Macular Degeneration (i-SIGHT): a Multicenter, Randomized, Double-masked, Clinical Device Trial
- ClinicalTrials.gov ID
- NCT04511936
- Acronym / sponsor ID
- i-SIGHT / ILS-AMD-101
- Conditions
- Dry Age-related Macular Degeneration
- Keywords
- AMD, Dry AMD
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: COVID-related delays.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- i-Lumen Scientific, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Mar 2021 (estimated)
- Primary completion
- 31 Jan 2022 (estimated)
- Study completion
- 31 Jan 2023 (estimated)
- First posted
- 13 Aug 2020 (actual)
- 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.
Evaluate the safety and efficacy of microcurrent stimulation therapy for patients with dry age-related macular degeneration.
Detailed description
Multi-center, double-masked, randomized trial of microcurrent stimulation for the treatment of patients affected with dry age-related macular degeneration.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| i-Lumen AMD Active | Active comparator | Device: i-Lumen AMD |
| i-Lumen AMD Sham | Sham comparator | Device: i-Lumen AMD Sham |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Dry AMD diagnosis.
Key exclusion criteria (1 listed)
- Wet AMD
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 |
|---|---|---|
| i-Lumen AMDMicrocurrent stimulator | Device | i-Lumen AMD Active |
| i-Lumen AMD ShamSham microcurrent stimulator | Device | i-Lumen AMD Sham |
Primary outcome
Mean change from baseline in best-corrected distance visual acuity (CDVA) at one month timepoint.
Time frame: 1 Month
1 secondary outcome
Best-corrected distance visual acuity (CDVA) response rate at 1 month visit.
Time frame: 1 Month
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 8 Apr 2021.
- 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.
Timothy Jackson, MD principal investigator
King's College London
Questions about this trial
What is this clinical trial studying?
A study testing i-Lumen AMD in people with Dry Age-related Macular Degeneration, run by i-Lumen Scientific, 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 1 inclusion and 1 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 8 Apr 2021. 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?
Mean change from baseline in best-corrected distance visual acuity (CDVA) at one month timepoint. (time frame: 1 Month). 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 8 Apr 2021.