NCT06046118 Photobiomodulation in Dry Age Related Macular Degeneration
| NCT ID | NCT06046118 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Azienda Ospedaliera Universitaria Mater Domini, Catanzaro |
| Condition | Age-Related Macular Degeneration |
| Study Type | INTERVENTIONAL |
| Enrollment | 180 participants |
| Start Date | 2023-04-01 |
| Primary Completion | 2024-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 180 participants in total. It began in 2023-04-01 with a primary completion date of 2024-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06046118 clinical trial?
This trial is open to participants of all sexes, aged 50 Years or older, studying Age-Related Macular Degeneration. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06046118 currently recruiting?
Yes, NCT06046118 is actively recruiting participants. Contact the research team at giuseppe.giannaccare@unicz.it for enrollment information.
Where is the NCT06046118 trial being conducted?
This trial is being conducted at Paris, France, Ferrara, Italy, Naples, Italy, Torino, Italy and 3 additional locations.
Who is sponsoring the NCT06046118 clinical trial?
NCT06046118 is sponsored by Azienda Ospedaliera Universitaria Mater Domini, Catanzaro. The trial plans to enroll 180 participants.