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DRUSEN: Photobiomodulation in Dry Age Related Macular Degeneration

Sponsor
Azienda Ospedaliera Universitaria Mater Domini, Catanzaro (Other)
Overall Status
Recruiting
CT.gov ID
NCT06046118
Collaborator
(none)
180
Enrollment
7
Locations
2
Arms
21
Anticipated Duration (Months)
25.7
Patients Per Site
1.2
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Device: Yellow and red light emitting diode photobiomodulation (Eye Light, Espansione Group, Bologna, Italy)
  • Device: Sham Mask
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
180 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
Outcomes of Photobiomodulation in DRy Age Related macUlar Degeneration: a proSpective multicEnter raNdomized Controlled (DRUSEN) Study
Actual Study Start Date :
Apr 1, 2023
Anticipated Primary Completion Date :
Dec 31, 2024
Anticipated Study Completion Date :
Dec 31, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Treatment group

Two cycles of treatment using continuous and pulsed yellow light followed by continuous and pulsed red light. Cycle 1 consists of 8 sessions (two sessions per week for 4 weeks) and cycle 2 consists of 6 sessions (two sessions per week for 3 weeks).

Device: Yellow and red light emitting diode photobiomodulation (Eye Light, Espansione Group, Bologna, Italy)
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 Comparator: Sham group

Sham treatment will occur using a sham mask, designed to release a very low level of light, in this way the patient will not be able to distinguish if he is receiving the treatment or not. Cycle 1 consists of 8 sessions (two sessions per week for 4 weeks) and cycle 2 consists of 6 sessions (two sessions per week for 3 weeks).

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

Outcome Measures

Primary Outcome Measures

  1. Best Corrected Visual Acuity variation [1 month, 2 months and 4 months after each cycle]

    ETDRS letters

  2. Drusen Volume Variation [1 month, 2 months and 4 months after each cycle]

    Based on SD-OCT Heidelberg

  3. Contrast sensitivity variation [1 month, 2 months and 4 months after each cycle]

    Based on Pelli Robson chart

Eligibility Criteria

Criteria

Ages Eligible for Study:
50 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Paris Paris France
2 Università degli Studi di Ferrara Ferrara Italy
3 Università degli studi della Campania Luigi Vanvitelli Napoli Italy
4 Università di Torino Torino Italy
5 University of Ankara Ankara Turkey
6 Koç University Hospital Koç Turkey
7 Earlam and Christopher Taunton United Kingdom

Sponsors and Collaborators

  • Azienda Ospedaliera Universitaria Mater Domini, Catanzaro

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Giuseppe Giannaccare, Professor, Azienda Ospedaliera Universitaria Mater Domini, Catanzaro
ClinicalTrials.gov Identifier:
NCT06046118
Other Study ID Numbers:
  • PBM AMD
First Posted:
Sep 21, 2023
Last Update Posted:
Sep 21, 2023
Last Verified:
Sep 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Giuseppe Giannaccare, Professor, Azienda Ospedaliera Universitaria Mater Domini, Catanzaro
Age related Macular Degeneration
Photobiomodulation
Additional relevant MeSH terms:
Macular Degeneration

Study Results

No Results Posted as of Sep 21, 2023