Photobiomodulation for Dry Age Related Macula Degeneration

NCT ID: NCT05507840

Last Updated: 2022-10-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

121 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-12-01

Study Completion Date

2027-12-01

Brief Summary

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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.

Detailed Description

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Conditions

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Photobiomodulation Age-Related Macular Degeneration

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Intervention

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

Group Type EXPERIMENTAL

Valeda machine

Intervention Type DEVICE

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

Control

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

Group Type SHAM_COMPARATOR

Valeda machine

Intervention Type DEVICE

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

Interventions

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Valeda machine

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Oslo University Hospital

OTHER

Sponsor Role lead

Responsible Party

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ANCA ROALD

Principal Investigator, MD dr. med.

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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456056

Identifier Type: -

Identifier Source: org_study_id

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