Photobiomodulation in Dry Age Related Macular Degeneration
NCT ID: NCT06046118
Last Updated: 2024-09-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
180 participants
INTERVENTIONAL
2023-04-01
2024-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
* 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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Study of Photobiomodulation to Treat Dry Age-Related Macular Degeneration (LIGHTSITE II)
NCT03878420
Study of Photobiomodulation to Treat Dry Age-Related Macular Degeneration (LIGHTSITE III)
NCT04065490
Study of Photobiomodulation to Treat Dry Age-Related Macular Degeneration
NCT02725762
Toronto and Oak Ridge Photobiomodulation Study for Dry Age Related Macular Degeneration
NCT00940407
Study of Application of Transcutaneous Pulsed Electrical Stimulation Around Eye in Age-related Macular Degeneration
NCT05259371
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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).
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 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).
Sham Mask
Low light emission mask (Sham Mask, Espansione group, Bologna, Italy)
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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 Mask
Low light emission mask (Sham Mask, Espansione group, Bologna, Italy)
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* Neurological diseases
* Psychiatric pathologies
* Herpes virus infections
* Dense cataract
* Pregnancy
* Other significant ocular and/or retinal diseases
50 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Azienda Ospedaliera Universitaria Mater Domini, Catanzaro
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Giuseppe Giannaccare
Professor
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of Paris
Paris, , France
Università degli Studi di Ferrara
Ferrara, , Italy
Università degli studi della Campania Luigi Vanvitelli
Napoli, , Italy
Università di Torino
Torino, , Italy
University of Ankara
Ankara, , Turkey (Türkiye)
Koç University Hospital
Koç, , Turkey (Türkiye)
Earlam and Christopher
Taunton, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Pierre Raphael Rothschild
Role: primary
Massimo Busin
Role: primary
Francesca Simonelli
Role: backup
Michele Reibaldi
Role: primary
References
Explore related publications, articles, or registry entries linked to this study.
Borrelli E, Coco G, Pellegrini M, Mura M, Ciarmatori N, Scorcia V, Carnevali A, Lucisano A, Borselli M, Rossi C, Reibaldi M, Ricardi F, Vagge A, Nicolo M, Forte P, Cartabellotta A, Hasanreisoglu M, Kesim C, Demirel S, Yanik O, Bernabei F, Rothschild PR, Farrant S, Giannaccare G. Safety, Tolerability, and Short-Term Efficacy of Low-Level Light Therapy for Dry Age-Related Macular Degeneration. Ophthalmol Ther. 2024 Nov;13(11):2855-2868. doi: 10.1007/s40123-024-01030-w. Epub 2024 Sep 13.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
PBM AMD
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.