Photobiomodulation for Dry Age Related Macula Degeneration

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.

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Key information

Conditions

Photobiomodulation Age-Related Macular Degeneration Eye Diseases Macular Degeneration Retinal Degeneration Retinal Diseases

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Valeda machine

Device

Photobiomodulation treatment with Valeda machine will be applied every six months for 2 years in patients with dry age related macula degeneration.

Primary outcomes

Percentage of patients that develope late AMD in the study eye compared with control after 3 years of follow-up

Time frame: 3 years

Sponsors and collaborators

Lead sponsor

Oslo University Hospital

Other

Registry information

Important dates

Study start: 2022
Primary completion: 2026
Study completion: 2027
First posted: Aug 19, 2022
Registry last updated: Oct 12, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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