Age-Related Macular DegenerationDRUSENNCT06046118
Photobiomodulation in Dry Age Related Macular Degeneration
A study testing Yellow and red light emitting diode photobiomodulation (Eye Light, Espansione Group, Bologna, Italy) in people with Age-Related Macular Degeneration, run by Azienda Ospedaliera Universitaria Mater Domini, Catanzaro at 7 sites in 4 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Age-Related Macular Degeneration
- What is being tested?
- Yellow and red light emitting diode photobiomodulation (Eye Light, Espansione Group, Bologna, Italy)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 180 participants
- Where
- 7 sitesin 4 countries
- Study dates
- 1 Apr 2023to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 join
- Concomitant epilepsy
- Neurological diseases
- Psychiatric pathologies
- Herpes virus infections
- Dense cataract
- Pregnancy
- Other significant ocular and/or retinal diseases
Trial locations and contacts
7 sites in 4 countries.
7 sites in 4 countries
Italy3 sites, 3 recruiting
- Recruiting
Università degli Studi di Ferrara
Ferrara
Massimo Busin
Marco Pellegrini, marco.pellegrini@hotmail.it
- Recruiting
Università degli studi della Campania Luigi Vanvitelli
Naples
Claudio Iovino, claudioiovino88@gmail.com
Francesca Simonelli
- Recruiting
Università di Torino
Torino
Michele Reibaldi
Enrico Borrelli, borrelli.enrico@yahoo.com
Turkey (Türkiye)2 sites, 2 recruiting
- Recruiting
University of Ankara
Ankara
Sibel Demirel, drsibeldemireltr@yahoo.com.tr
- Recruiting
Koç University Hospital
Koç
Murat Murat Hasanreisoğlu, drhasanreisoglu@gmail.com
France1 site, 1 recruiting
- Recruiting
University of Paris
Paris
Pierre Raphael Rothschild
Federico Bernabei, federico.bernabei89@gmail.com
United Kingdom1 site, 1 recruiting
- Recruiting
Earlam and Christopher
Taunton
Sarah Farrant, sarahfarrant@gmail.com
About this study
Official title: Outcomes of Photobiomodulation in DRy Age Related macUlar Degeneration: a proSpective multicEnter raNdomized Controlled (DRUSEN) Study
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.
Read more
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.
- Conditions
- Age-Related Macular Degeneration
- Being tested
- Yellow and red light emitting diode photobiomodulation (Eye Light, Espansione Group, Bologna, Italy), Sham Mask
- Keywords
- Age related Macular Degeneration, Photobiomodulation
- Medical subject headings
- Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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).
Cycle 1: 8 sessions (two PBM per week for 4 weeks); Cycle 2: 6 sessions (two PBM per week for 3 weeks).
Sham MaskDevice
Low light emission mask (Sham Mask, Espansione group, Bologna, Italy)
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | 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). Receives: Device: Yellow and red light emitting diode photobiomodulation (Eye Light, Espansione Group, Bologna, Italy) |
| Sham group | Sham comparator | 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). Receives: Device: Sham Mask |
What is being measured
The primary outcome is the main question the study is designed to answer.
Best Corrected Visual Acuity variation
ETDRS letters
Measured: 1 month, 2 months and 4 months after each cycle
Drusen Volume Variation
Based on SD-OCT Heidelberg
Measured: 1 month, 2 months and 4 months after each cycle
Contrast sensitivity variation
Based on Pelli Robson chart
Measured: 1 month, 2 months and 4 months after each cycle
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study start1 Apr 2023
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Age-Related Macular DegenerationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliera Universitaria Mater Domini, Catanzaro
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giuseppe Giannaccare, Azienda Ospedaliera Universitaria Mater Domini, Catanzaro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06046118
- Sponsor's protocol ID
- PBM AMD
- Acronym
- DRUSEN
- Status last verified
- Sep 2024
- First submitted
- 14 Sep 2023
- Last updated
- 19 Sep 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 39271642
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes of Photobiomodulation in DRy Age Related macUlar Degeneration: a proSpective multicEnter raNdomized Controlled (DRUSEN) Study
- ClinicalTrials.gov ID
- NCT06046118
- Acronym / sponsor ID
- DRUSEN / PBM AMD
- Conditions
- Age-Related Macular Degeneration
- Keywords
- Age related Macular Degeneration, Photobiomodulation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Azienda Ospedaliera Universitaria Mater Domini, CatanzaroUniversity, hospital or other
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 21 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Device: Yellow and red light emitting diode photobiomodulation (Eye Light, Espansione Group, Bologna, Italy)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 group | Sham comparator | Device: Sham MaskSham 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). |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- Concomitant epilepsy
- Neurological diseases
- Psychiatric pathologies
- Herpes virus infections
- Dense cataract
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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). | Device | Treatment group |
| Sham MaskLow light emission mask (Sham Mask, Espansione group, Bologna, Italy) | Device | Sham group |
Primary outcome
Best Corrected Visual Acuity variation
Time frame: 1 month, 2 months and 4 months after each cycle
ETDRS letters
Drusen Volume Variation
Time frame: 1 month, 2 months and 4 months after each cycle
Based on SD-OCT Heidelberg
Contrast sensitivity variation
Time frame: 1 month, 2 months and 4 months after each cycle
Based on Pelli Robson chart
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Derived from this study: PubMed 39271642Borrelli 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
7 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Yellow and red light emitting diode photobiomodulation (Eye Light, Espansione Group, Bologna, Italy) in people with Age-Related Macular Degeneration, run by Azienda Ospedaliera Universitaria Mater Domini, Catanzaro at 7 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Italy, Turkey (Türkiye), France, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Giuseppe Giannaccare (003909613647135, giuseppe.giannaccare@unicz.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Best Corrected Visual Acuity variation (time frame: 1 month, 2 months and 4 months after each cycle). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06046118, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.