Photobiomodulation for Dry Age Related Macula Degeneration

N/ANot Yet RecruitingNCT05507840

Oslo University Hospital121 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

121

Conditions

Photobiomodulation Age-Related Macular Degeneration

Interventions

Valeda machineDEVICE

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

Eligibility

Sex: ALLMin age: 50 Years

Medical Language ↔ Plain English

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

Outcomes

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

Data from ClinicalTrials.gov

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