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Photobiomodulation for Dry Age Related Macula Degeneration

University of Oslo (UIO) logo

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

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

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

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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