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NCT05507840 Clinical Trial

Photobiomodulation for Dry Age Related Macula Degeneration

Age-Related Macular Degeneration Clinical Trial

Official title:
Photobiomodulation for Dry Age Related Macula Degeneration

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT05507840
Other study ID # 456056
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date December 1, 2022
Est. completion date December 1, 2027

Study information
Verified date October 2022
Source Oslo University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 121
Est. completion date December 1, 2027
Est. primary completion date December 1, 2026
Accepts healthy volunteers No
Gender All
Age group 50 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

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.

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Oslo University Hospital

Outcome
Type Measure Description Time frame Safety issue
Primary Percentage of patients that develope late AMD in the study eye compared with control after 3 years of follow-up 3 years
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