Age Related Macular DegenerationELECTROLIGHTNCT04522999
Study of Photobiomodulation Effect on Electroretinogram Outcomes in Dry Age-Related Macular Degeneration
A study testing Photobiomodulation in people with Age Related Macular Degeneration, run by LumiThera, Inc. at 1 site in United States.
Trial summary
To evaluate the ability of Photobiomodulation (PBM) treatment using the Valeda® Light Delivery System to improve Electroretinogram (ERG) outcomes in subjects with dry Age-related Macular Degeneration (AMD). Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Age Related Macular Degeneration
- What is being tested?
- Photobiomodulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Aug 2020to 13 Aug 2021
- 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
- Male or female at least 50 years of age at Screening visit
- ETDRS BCVA letter score of between 50* and 75* (Snellen equivalent of 20/100 to 20/32)
- Diagnosis of dry AMD
- Able to communicate well with the Investigator and able to understand and comply with the requirements of the study
- Informed of the nature of this study and has provided written, informed consent in accordance with institutional, local and national regulatory guidelines
Who cannot join
- Current or history of neovascular maculopathy
- Presence of center involving GA within the central ETDRS 1 mm diameter at Screening
- Media opacities, including cataracts, which might interfere with visual acuity or imaging in the study eye(s)
- Posterior capsule opacification, which might interfere with visual acuity or imaging in the study eye(s)
- Invasive eye surgery (e.g. cataract, capsulotomy) on a qualifying eye within three 3 months prior to Screening
- Visually significant disease in any ocular structure apart from dry AMD
Show all 13Show fewer
- Serious medical illness that will prevent the subject from performing study activities
- Presence of or history of malignancy within the past 5 years
- Presence or history of known light sensitivity to yellow light, red light, or near infrared radiation (NIR), or if they have a history of light activated CNS disorders (e.g. epilepsy, migraine)
- History of neurologic condition known to affect visual function
- History of drug, alcohol or substance abuse within 3 months prior to Screening
- Participation in any other clinical study at time of screening, or has received an investigational drug or treatment with an investigational device within 3 months prior to Screening
- In the opinion of the Investigator, is unlikely to comply with the study protocol
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Objective Study to Evaluate the Ability of Photobiomodulation to Improve Electroretinogram Outcomes in Subjects With Dry Age-Related Macular Degeneration
To evaluate the ability of Photobiomodulation (PBM) treatment using the Valeda® Light Delivery System to improve Electroretinogram (ERG) outcomes in subjects with dry Age-related Macular Degeneration (AMD).
Read the detailed description
This study is an open label, prospective pilot study to evaluate retinal function after PBM treatment in eyes with dry AMD using ERG. The target enrollment is 15 subjects in up to two sites in the US. All subjects will receive PBM Treatment.
Subjects will receive three PBM treatments per week for three weeks for a total of nine sessions over 3 weeks.
The primary analysis will examine multi-focal ERG function changes from baseline to Month 1. Secondary analyses will examine multi-focal ERG function change from baseline to Month 3 and 6. Other endpoints will include other functions of ERG, ETDRS Visual Acuity, Contrast Sensitivity, Perimetry, Color Vision test and the Amsler grid test.
- Conditions
- Age Related Macular Degeneration
- Being tested
- Photobiomodulation
- Medical subject headings
- Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PhotobiomodulationDevice
The Valeda™ Light Delivery System
| Study group | Role | What they receive |
|---|---|---|
| Photobiomodulation | Experimental | Valeda™ Light Delivery System Receives: Device: Photobiomodulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
ERG function
ERG assessments (Multifocal ERG (mfERG), Photopic Negative Response (PhNR), Multi-luminance Flicker ERG (ML-FERG) and Fixed-luminance Flicker ERG (FL-FERG)) will provide an output of retinal function.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2020
- Study start20 Aug 2020
- Primary completion13 Aug 2021
- Study completion13 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- LumiThera, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04522999
- Sponsor's protocol ID
- CSP007
- Acronym
- ELECTROLIGHT
- Status last verified
- Aug 2021
- First submitted
- 11 Aug 2020
- Last updated
- 2 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Objective Study to Evaluate the Ability of Photobiomodulation to Improve Electroretinogram Outcomes in Subjects With Dry Age-Related Macular Degeneration
- ClinicalTrials.gov ID
- NCT04522999
- Acronym / sponsor ID
- ELECTROLIGHT / CSP007
- Conditions
- Age Related Macular Degeneration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- LumiThera, Inc.Industry (pharma, biotech, devices)
- Study start
- 20 Aug 2020 (actual)
- Primary completion
- 13 Aug 2021 (actual)
- Study completion
- 13 Aug 2021 (actual)
- First posted
- 21 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.
To evaluate the ability of Photobiomodulation (PBM) treatment using the Valeda® Light Delivery System to improve Electroretinogram (ERG) outcomes in subjects with dry Age-related Macular Degeneration (AMD).
Detailed description
This study is an open label, prospective pilot study to evaluate retinal function after PBM treatment in eyes with dry AMD using ERG. The target enrollment is 15 subjects in up to two sites in the US. All subjects will receive PBM Treatment.
Subjects will receive three PBM treatments per week for three weeks for a total of nine sessions over 3 weeks.
The primary analysis will examine multi-focal ERG function changes from baseline to Month 1. Secondary analyses will examine multi-focal ERG function change from baseline to Month 3 and 6. Other endpoints will include other functions of ERG, ETDRS Visual Acuity, Contrast Sensitivity, Perimetry, Color Vision test and the Amsler grid test.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Photobiomodulation | Experimental | Device: PhotobiomodulationValeda™ Light Delivery System |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female at least 50 years of age at Screening visit
- ETDRS BCVA letter score of between 50* and 75* (Snellen equivalent of 20/100 to 20/32)
- Diagnosis of dry AMD
- Able to communicate well with the Investigator and able to understand and comply with the requirements of the study
- Informed of the nature of this study and has provided written, informed consent in accordance with institutional, local and national regulatory guidelines
Key exclusion criteria (13 listed)
- Current or history of neovascular maculopathy
- Presence of center involving GA within the central ETDRS 1 mm diameter at Screening
- Media opacities, including cataracts, which might interfere with visual acuity or imaging in the study eye(s)
- Posterior capsule opacification, which might interfere with visual acuity or imaging in the study eye(s)
- Invasive eye surgery (e.g. cataract, capsulotomy) on a qualifying eye within three 3 months prior to Screening
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 |
|---|---|---|
| PhotobiomodulationThe Valeda™ Light Delivery System | Device | Photobiomodulation |
Primary outcome
ERG function
Time frame: 3 months
ERG assessments (Multifocal ERG (mfERG), Photopic Negative Response (PhNR), Multi-luminance Flicker ERG (ML-FERG) and Fixed-luminance Flicker ERG (FL-FERG)) will provide an output of retinal function.
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 2 Sep 2021.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Photobiomodulation in people with Age Related Macular Degeneration, run by LumiThera, Inc. at 1 site in United States.
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 5 inclusion and 13 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 2 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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 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?
ERG function (time frame: 3 months). 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 2 Sep 2021.