PhotobiomodulationNCT05507840
Photobiomodulation for Dry Age Related Macula Degeneration
A study testing Valeda machine in people with Photobiomodulation and Age-Related Macular Degeneration, run by Oslo University Hospital.
Trial summary
The study will investigate the effect of photobiomodulation treatment on the risk of developing late age related macula degeneration (AMD) in the study eye in patients with wet AMD in the fellow eye. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Photobiomodulation, Age-Related Macular Degeneration
- What is being tested?
- Valeda machine
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 121 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2022to 1 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- patients with dry AMD in the study eye and wet AMD in the control eye
Who cannot join
- Geographic atrophy of the central macular region at enrolment
- Previous/ active wet AMD in the study eye
- A history of epilepsy
- Retinal diseases apart from AMD
- Significant media opacities
- Cataracts worse than grade 2 (LOCS III classification)
Show all 11Show fewer
- Change in AREDS 2 supplements (vitamins) 1 month before the study and during the study trial was allowed.
- Ongoing systemic medications that are photosensitizing (e.g. tetracyclins)
- Systemic medications during the last 6 months that can cause deposits in the macular region (hydroxychloroquine, amiodarone)
- Unable to give informed consent
- Unable to cooperate with the treatment and follow-up
About this study
The study will investigate the effect of photobiomodulation treatment on the risk of developing late age related macula degeneration (AMD) in the study eye in patients with wet AMD in the fellow eye.
- Being tested
- Valeda machine
- Keywords
- choroidal neovascular membrane
- Medical subject headings
- Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Valeda machineDevice
Photobiomodulation treatment with Valeda machine will be applied every six months for 2 years in patients with dry age related macula degeneration.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Near or infra red light provided by the Valeda machine will be applied in the intervention eye Receives: Device: Valeda machine |
| Control | Sham comparator | Light with very low intensity provided by the same Valeda machine will be applied in the control eye Receives: Device: Valeda machine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients that develope late AMD in the study eye compared with control after 3 years of follow-up
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2022
- Study start1 Dec 2022 (estimated)
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PhotobiomodulationStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- 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, Care provider
- Enrolment
- 121 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ANCA ROALD, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05507840
- Sponsor's protocol ID
- 456056
- Status last verified
- Oct 2022
- First submitted
- 30 Jun 2022
- Last updated
- 12 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Photobiomodulation for Dry Age Related Macula Degeneration
- ClinicalTrials.gov ID
- NCT05507840
- Acronym / sponsor ID
- 456056
- Keywords
- choroidal neovascular membrane
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 121 participants (estimated)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Study start
- 1 Dec 2022 (estimated)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 19 Aug 2022 (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.
The study will investigate the effect of photobiomodulation treatment on the risk of developing late age related macula degeneration (AMD) in the study eye in patients with wet AMD in the fellow eye.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Device: Valeda machineNear or infra red light provided by the Valeda machine will be applied in the intervention eye |
| Control | Sham comparator | Device: Valeda machineLight with very low intensity provided by the same Valeda machine will be applied in the control eye |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients with dry AMD in the study eye and wet AMD in the control eye
Key exclusion criteria (11 listed)
- Geographic atrophy of the central macular region at enrolment
- Previous/ active wet AMD in the study eye
- A history of epilepsy
- Retinal diseases apart from AMD
- Significant media opacities
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 |
|---|---|---|
| Valeda machinePhotobiomodulation treatment with Valeda machine will be applied every six months for 2 years in patients with dry age related macula degeneration. | Device | Control, Intervention |
Primary outcome
Percentage of patients that develope late AMD in the study eye compared with control after 3 years of follow-up
Time frame: 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2022.
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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.
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 Valeda machine in people with Photobiomodulation and Age-Related Macular Degeneration, run by Oslo University Hospital.
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 11 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: opening soon, as of the sponsor's last update on 12 Oct 2022. 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?
This study is still under way. Results are not available in the source record yet.
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?
Percentage of patients that develope late AMD in the study eye compared with control after 3 years of follow-up (time frame: 3 years). 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 12 Oct 2022.