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Photobiomodulation for Dry Age Related Macula Degeneration

Primary Purpose

Photobiomodulation, Age-Related Macular Degeneration

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Valeda machine
Sponsored by
Oslo University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Photobiomodulation focused on measuring choroidal neovascular membrane

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Sham Comparator

    Arm Label

    Intervention

    Control

    Arm Description

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

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

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    Full Information

    First Posted
    June 30, 2022
    Last Updated
    October 11, 2022
    Sponsor
    Oslo University Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05507840
    Brief Title
    Photobiomodulation for Dry Age Related Macula Degeneration
    Official Title
    Photobiomodulation for Dry Age Related Macula Degeneration
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    December 1, 2022 (Anticipated)
    Primary Completion Date
    December 1, 2026 (Anticipated)
    Study Completion Date
    December 1, 2027 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Oslo University Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Photobiomodulation, Age-Related Macular Degeneration
    Keywords
    choroidal neovascular membrane

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare Provider
    Allocation
    Randomized
    Enrollment
    121 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Intervention
    Arm Type
    Experimental
    Arm Description
    Near or infra red light provided by the Valeda machine will be applied in the intervention eye
    Arm Title
    Control
    Arm Type
    Sham Comparator
    Arm Description
    Light with very low intensity provided by the same Valeda machine will be applied in the control eye
    Intervention Type
    Device
    Intervention Name(s)
    Valeda machine
    Intervention Description
    Photobiomodulation treatment with Valeda machine will be applied every six months for 2 years in patients with dry age related macula degeneration.
    Primary Outcome Measure Information:
    Title
    Percentage of patients that develope late AMD in the study eye compared with control after 3 years of follow-up
    Time Frame
    3 years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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

    12. IPD Sharing Statement

    Learn more about this trial

    Photobiomodulation for Dry Age Related Macula Degeneration

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