Using light therapy to treat dry age-related macular degeneration
Outcomes of Photobiomodulation in DRy Age Related macUlar Degeneration: a proSpective multicEnter raNdomized Controlled (DRUSEN) Study
This study tests if light therapy can help people with dry age-related macular degeneration see better and reduce eye deposits called drusen.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 180 (estimated) |
| Ages | 50 Years and up |
| Sex | All |
| Sponsor | Azienda Ospedaliera Universitaria Mater Domini, Catanzaro Academic / other |
| Locations | 7 sites (Paris and 6 other locations) |
| Trial ID | NCT06046118 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effects of Yellow and Red Light Emitting Diode photobiomodulation on patients with dry age-related macular degeneration (AMD). Participants will be randomly assigned to receive either the light therapy or a sham treatment. The therapy involves two cycles of sessions, focusing on reducing drusen volume and improving visual acuity and contrast sensitivity. Each cycle consists of multiple sessions with specific light exposure protocols.
Who should consider this trial
Good fit: Ideal candidates are individuals diagnosed with dry AMD who have a best-corrected visual acuity of more than 40 letters on the ETDRS scale.
Not a fit: Patients with significant ocular diseases, neurological disorders, or those who are pregnant may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could improve vision and quality of life for patients with dry AMD.
How similar studies have performed: While the approach of using photobiomodulation is gaining interest, the specific application in dry AMD is still being explored and may be considered novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Paris and 6 other locations
- University of Paris — Paris, France (Recruiting)
- Università degli Studi di Ferrara — Ferrara, Italy (Recruiting)
- Università degli studi della Campania Luigi Vanvitelli — Naples, Italy (Recruiting)
- Università di Torino — Torino, Italy (Recruiting)
- University of Ankara — Ankara, Turkey (Türkiye) (Recruiting)
- Koç University Hospital — Koç, Turkey (Türkiye) (Recruiting)
- Earlam and Christopher — Taunton, United Kingdom (Recruiting)
Study contacts
- Study coordinator: Giuseppe Giannaccare
- Email: giuseppe.giannaccare@unicz.it
- Phone: 003909613647135
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.