At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Yellow and red light emitting diode photobiomodulation (Eye Light, Espansione Group, Bologna, Italy) (device), Sham Mask (device)
- How long the study runs
- Study runs about 20 months (dates as stated)
- About the drug or intervention
- Yellow and red light emitting diode photobiomodulation (Eye Light, Espansione Group, Bologna, Italy) — device: 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). · Sham Mask — device: Low light emission mask (Sham Mask, Espansione group, Bologna, Italy)
- Patient visit burden
- Not specified by the sponsor
In plain English
This study is looking at photobiomodulation (a type of light treatment) for people with dry age-related macular degeneration, an eye condition that can affect central vision as you get older. The study is being run by Azienda Ospedaliera Universitaria Mater Domini in Catanzaro, Italy.
Who can take part
- Adults with dry age-related macular degeneration graded AREDS 2 to 3
- Good enough vision to read most of an eye chart (a score of more than 40 letters)
- Able to understand the study and follow its instructions
Who may not be able to
- Epilepsy
- Neurological diseases (conditions affecting the brain or nerves)
- Psychiatric (mental health) conditions
- Herpes virus infections
- Dense cataract (a badly clouded lens in the eye)
- Pregnancy
- Other serious eye or retinal conditions
What taking part involves
- • Not stated — ask the trial team
Time commitment: Not stated — ask the trial team about how many visits there are, how long the study lasts, and what taking part involves.
Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.
- Type of study
- Testing a treatment
- Ages
- 50 Years and over
- Who
- All
- Number of participants
- 180
- Started
- 2023-04-01
- Last checked
- 2024-09
Plain English Summary
What is this study?
- • Testing a new treatment for age-related macular degeneration
- • NA - 180 participants
- • 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)
Who can take part?
- • Ages 50 Years and over
- • Diagnosed with age-related macular degeneration
Where?
- • Taunton - Earlam and Christopher
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 50 Years and over
- Who can join: All genders
What the study is looking for
- ✓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
Who cannot take part
- ✗Concomitant epilepsy
- ✗Neurological diseases
- ✗Psychiatric pathologies
- ✗Herpes virus infections
- ✗Dense cataract
See the full criteria
Where Is This Study? (1 UK site)
Earlam and Christopher
Taunton, United Kingdom
How to Get in Touch
Giuseppe Giannaccare
Sponsor contactCONTACT