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Photobiomodulation in Dry Age Related Macular Degeneration (DRUSEN)

Primary Purpose

Age-Related Macular Degeneration

Status
Recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Yellow and red light emitting diode photobiomodulation (Eye Light, Espansione Group, Bologna, Italy)
Sham Mask
Sponsored by
Azienda Ospedaliera Universitaria Mater Domini, Catanzaro
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Age-Related Macular Degeneration focused on measuring Age related Macular Degeneration, Photobiomodulation

Eligibility Criteria

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

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

Sites / Locations

  • University of ParisRecruiting
  • Università degli Studi di FerraraRecruiting
  • Università degli studi della Campania Luigi VanvitelliRecruiting
  • Università di TorinoRecruiting
  • University of AnkaraRecruiting
  • Koç University HospitalRecruiting
  • Earlam and ChristopherRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Treatment group

Sham group

Arm Description

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).

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).

Outcomes

Primary Outcome Measures

Best Corrected Visual Acuity variation
ETDRS letters
Drusen Volume Variation
Based on SD-OCT Heidelberg
Contrast sensitivity variation
Based on Pelli Robson chart

Secondary Outcome Measures

Full Information

First Posted
September 14, 2023
Last Updated
September 14, 2023
Sponsor
Azienda Ospedaliera Universitaria Mater Domini, Catanzaro
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1. Study Identification

Unique Protocol Identification Number
NCT06046118
Brief Title
Photobiomodulation in Dry Age Related Macular Degeneration
Acronym
DRUSEN
Official Title
Outcomes of Photobiomodulation in DRy Age Related macUlar Degeneration: a proSpective multicEnter raNdomized Controlled (DRUSEN) Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2023 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Azienda Ospedaliera Universitaria Mater Domini, Catanzaro

4. Oversight

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

5. 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.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
180 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment group
Arm Type
Experimental
Arm Description
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).
Arm Title
Sham group
Arm Type
Sham Comparator
Arm Description
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).
Intervention Type
Device
Intervention Name(s)
Yellow and red light emitting diode photobiomodulation (Eye Light, Espansione Group, Bologna, Italy)
Intervention Description
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).
Intervention Type
Device
Intervention Name(s)
Sham Mask
Intervention Description
Low light emission mask (Sham Mask, Espansione group, Bologna, Italy)
Primary Outcome Measure Information:
Title
Best Corrected Visual Acuity variation
Description
ETDRS letters
Time Frame
1 month, 2 months and 4 months after each cycle
Title
Drusen Volume Variation
Description
Based on SD-OCT Heidelberg
Time Frame
1 month, 2 months and 4 months after each cycle
Title
Contrast sensitivity variation
Description
Based on Pelli Robson chart
Time Frame
1 month, 2 months and 4 months after each cycle

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Giuseppe Giannaccare
Phone
003909613647135
Email
giuseppe.giannaccare@unicz.it
Facility Information:
Facility Name
University of Paris
City
Paris
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pierre Raphael Rothschild
First Name & Middle Initial & Last Name & Degree
Federico Bernabei
Email
federico.bernabei89@gmail.com
Facility Name
Università degli Studi di Ferrara
City
Ferrara
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Massimo Busin
First Name & Middle Initial & Last Name & Degree
Marco Pellegrini
Email
marco.pellegrini@hotmail.it
Facility Name
Università degli studi della Campania Luigi Vanvitelli
City
Napoli
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Claudio Iovino
Email
claudioiovino88@gmail.com
First Name & Middle Initial & Last Name & Degree
Francesca Simonelli
Facility Name
Università di Torino
City
Torino
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michele Reibaldi
First Name & Middle Initial & Last Name & Degree
Enrico Borrelli
Email
borrelli.enrico@yahoo.com
Facility Name
University of Ankara
City
Ankara
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sibel Demirel
Email
drsibeldemireltr@yahoo.com.tr
Facility Name
Koç University Hospital
City
Koç
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Murat Murat Hasanreisoğlu
Email
drhasanreisoglu@gmail.com
Facility Name
Earlam and Christopher
City
Taunton
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sarah Farrant
Email
sarahfarrant@gmail.com

12. IPD Sharing Statement

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Photobiomodulation in Dry Age Related Macular Degeneration

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