Not yet recruiting NCT05507840
Photobiomodulation for Dry Age Related Macula Degeneration
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Valeda machine.
- Who it may be relevant to
- Registry conditions: Photobiomodulation, Age-Related Macular Degeneration. Basic parameters: from 50 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- Device Valeda machine
Photobiomodulation treatment with Valeda machine will be applied every six months for 2 years in patients with dry age related macula degeneration.
Primary outcome measures
- Percentage of patients that develope late AMD in the study eye compared with control after 3 years of follow-up [Time frame: 3 years]
Eligibility criteria
Inclusion criteria
- patients with dry AMD in the study eye and wet AMD in the control eye
Exclusion criteria
- 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)
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT05507840 · 456056