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NCT Number: NCT06046118

Photobiomodulation in Dry Age Related Macular Degeneration

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.

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Key information

Conditions

Age-Related Macular Degeneration Eye Diseases Macular Degeneration Retinal Degeneration Retinal Diseases

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Paris, Paris, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 comply with the requirements of the study

Exclusion criteria

  • Concomitant epilepsy
  • Neurological diseases
  • Psychiatric pathologies
  • Herpes virus infections
  • Dense cataract
  • Pregnancy
  • Other significant ocular and/or retinal diseases

Treatment and study plan

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

Device

Each session consists of:

  • 1st phase: 300 seconds of continuous Yellow light (eyes closed) + 60 seconds of pulsed Yellow light (eyes opened)
  • 2nd phase: 300 seconds of continuous Red light(eyes closed) + 60 seconds of pulsed Red light (eyes opened).

Cycle 1: 8 sessions (two PBM per week for 4 weeks); Cycle 2: 6 sessions (two PBM per week for 3 weeks).

Sham Mask

Device

Low light emission mask (Sham Mask, Espansione group, Bologna, Italy)

Primary outcomes

  1. Best Corrected Visual Acuity variation

    Time frame: 1 month, 2 months and 4 months after each cycle

    ETDRS letters

  2. Drusen Volume Variation

    Time frame: 1 month, 2 months and 4 months after each cycle

    Based on SD-OCT Heidelberg

  3. Contrast sensitivity variation

    Time frame: 1 month, 2 months and 4 months after each cycle

    Based on Pelli Robson chart

Study contacts

Contact information is provided by the study sponsor or research team.

Giuseppe Giannaccare

CONTACT

[email protected]

003909613647135

Sponsors and collaborators

Lead sponsor

Azienda Ospedaliera Universitaria Mater Domini, Catanzaro

Other

Registry information

Official study title

Outcomes of Photobiomodulation in DRy Age Related macUlar Degeneration: a proSpective multicEnter raNdomized Controlled (DRUSEN) Study

Acronym: DRUSEN

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Sep 21, 2023
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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