Photobiomodulation for Dry Age Related Macula Degeneration

University of Oslo (UIO)

Status: Not yet enrolling

Conditions: Age-Related Macular Degeneration; Photobiomodulation

Treatments: Device: Valeda machine

Study type: Interventional

Funder types: Other

Identifiers

NCT05507840

456056

Details and patient eligibility

About

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.

Enrollment: 121 estimated patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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121 participants in 2 patient groups

Intervention

Experimental group

Description:

Near or infra red light provided by the Valeda machine will be applied in the intervention eye

Treatment:

Device: Valeda machine

Control

Sham Comparator group

Description:

Light with very low intensity provided by the same Valeda machine will be applied in the control eye

Treatment:

Device: Valeda machine