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Photobiomodulation for Dry Age Related Macula Degeneration

Sponsor
Oslo University Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05507840
Collaborator
(none)
121
Enrollment
2
Arms
60
Anticipated Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Device: Valeda machine
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
121 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Care Provider)
Primary Purpose:
Treatment
Official Title:
Photobiomodulation for Dry Age Related Macula Degeneration
Anticipated Study Start Date :
Sep 1, 2022
Anticipated Primary Completion Date :
Sep 1, 2026
Anticipated Study Completion Date :
Sep 1, 2027

Arms and Interventions

Arm Intervention/Treatment
Experimental: Intervention

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

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.
Sham Comparator: Control

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

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.

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
50 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Oslo University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
ANCA ROALD, Principal Investigator, MD dr. med., Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT05507840
Other Study ID Numbers:
  • 456056
First Posted:
Aug 19, 2022
Last Update Posted:
Aug 25, 2022
Last Verified:
Aug 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by ANCA ROALD, Principal Investigator, MD dr. med., Oslo University Hospital
choroidal neovascular membrane
Additional relevant MeSH terms:
Macular Degeneration

Study Results

No Results Posted as of Aug 25, 2022