Photobiomodulation for Dry Age Related Macula Degeneration

October 11, 2022 updated by: ANCA ROALD, Oslo University Hospital
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 Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

121

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage of patients that develope late AMD in the study eye compared with control after 3 years of follow-up
Time Frame: 3 years
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oslo University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

December 1, 2022

Primary Completion (Anticipated)

December 1, 2026

Study Completion (Anticipated)

December 1, 2027

Study Registration Dates

First Submitted

June 30, 2022

First Submitted That Met QC Criteria

August 18, 2022

First Posted (Actual)

August 19, 2022

Study Record Updates

Last Update Posted (Actual)

October 12, 2022

Last Update Submitted That Met QC Criteria

October 11, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 456056

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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