Photobiomodulation in Dry Age Related Macular Degeneration

Last updated: September 6, 2024
Sponsor: Azienda Ospedaliera Universitaria Mater Domini, Catanzaro
Overall Status: Active - Recruiting

Phase

N/A

Condition

Aging

Macular Degeneration

Myopic Macular Degeneration

Treatment

Sham Mask

Yellow and red light emitting diode photobiomodulation (Eye Light, Espansione Group, Bologna, Italy)

Clinical Study ID

NCT06046118
PBM AMD
  • Ages > 50
  • All Genders

Study Summary

The goal of this clinical trial is to evaluate effects of consecutive Yellow and Red Light Emitting Diode photobiomodulation in dry age-related macular degeneration (AMD). The main questions it aims to answer are:

  • Is Yellow and Red Light Emitting Diode photobiomodulation effective in decreasing drusen volume in patients affected by dry AMD?

  • Does Yellow and Red Light Emitting Diode photobiomodulation increase visual acuity and contrast sensitivity in patients affected by dry AMD? Participants will be randomly assigned to a treatment or a sham group.

Treatment consists in two cycles with two phases each:

  • 1st phase: 300 seconds of continuous Yellow light with eyes closed + 60 seconds of pulsed Yellow light with eyes opened;

  • 2d phase: 300 seconds of continuous Red light with eyes closed + 60 seconds of pulsed Red light with eyes opened.

Cycle 1 consists of 8 sessions (two PBM per week for 4 weeks) and cycle 2 consists of 6 sessions (two PBM per week for 3 weeks).

Researchers will compare patients in the treatment group to those in the sham group to evaluate differences in objective signs and subjective symptoms of dry AMD.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • BCVA ETDRS > 40 L ETDRS at 4 meters

  • Diagnosis of DRY AMD AREDS grade 2-3

  • Ability to communicate well with the investigator and able to understand and complywith the requirements of the study

Exclusion

Exclusion Criteria:

  • Concomitant epilepsy

  • Neurological diseases

  • Psychiatric pathologies

  • Herpes virus infections

  • Dense cataract

  • Pregnancy

  • Other significant ocular and/or retinal diseases

Study Design

Total Participants: 180
Treatment Group(s): 2
Primary Treatment: Sham Mask
Phase:
Study Start date:
April 01, 2023
Estimated Completion Date:
December 31, 2024

Connect with a study center

  • University of Paris

    Paris,
    France

    Active - Recruiting

  • Università degli Studi di Ferrara

    Ferrara,
    Italy

    Active - Recruiting

  • Università degli studi della Campania Luigi Vanvitelli

    Napoli,
    Italy

    Active - Recruiting

  • Università di Torino

    Torino,
    Italy

    Active - Recruiting

  • University of Ankara

    Ankara,
    Turkey

    Active - Recruiting

  • Koç University Hospital

    Koç,
    Turkey

    Active - Recruiting

  • Earlam and Christopher

    Taunton,
    United Kingdom

    Active - Recruiting

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