Evaluating very low-level red light therapy for dry age-related macular degeneration
| ISRCTN | ISRCTN14626095 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14626095 |
| Sponsor | Low Vision Academy |
| Funder | Low Vision Academy |
- Submission date
- 21/09/2026
- Registration date
- 24/09/2026
- Last edited
- 24/09/2026
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Eye Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Marcella Nebbioso
Scientific, Public
Scientific, Public
Department of Sense Organs, Faculty of Medicine and Odontology, Sapienza University of Rome, p. le A.
Moro 5
Rome
00185
Italy
| Phone | +39 (0)3392156212 |
|---|---|
| marcella.nebbioso@uniroma1.it |
Dr Pierdomenico D'Andrea
Public, Principal investigator
Public, Principal investigator
Department of Medicine and Aging Sciences, University “G. D’Annunzio” Chieti-Pescara, Chieti Italy
Via Rieti 45
Pescara
65121
Italy
| Phone | +39 (0)3314331171 |
|---|---|
| p.dandrea@riabilitazioneunich.it |
Study information
| Primary study design | Interventional |
|---|---|
| Allocation | Randomized controlled trial |
| Masking | Blinded (masking used) |
| Control | Placebo |
| Assignment | Parallel |
| Purpose | Treatment |
| Scientific title | Six-month multicenter clinical study evaluating the safety and efficacy of low fluence photobiomodulation using a wearable multi-wavelength visible light device in nonexudative age-related macular degeneration |
| Study objectives | |
| Ethics approval(s) |
Approved 30/09/2022, Low Vision Academy Scientific Ethics Committee (Piazza Sempione 3, Milano, 20145, Italy; +39 (0)23315865; a.manassero@fgeditore.it), ref: 2022/C930 |
| Health condition(s) or problem(s) studied | Nonexudative age-related macular degeneration (dry AMD) |
| Intervention | Patients were randomized (approximate 2:1 allocation ratio) using a computer-generated permuted block sequence (Research Randomizer). Randomisation was performed strictly at the patient level (both eyes of a participant received the same assignment). Allocation concealment and blinding were managed by an independent, unblinded study coordinator who generated the allocation sequence, scheduled participants, and distributed physically identical devices. Participants and data analysts remained strictly blinded throughout the study (single-blind trial). Active treatment arm: Participants received photobiomodulation (PBM) therapy using a wearable, frame-based low-level red light device (incorporating non-coaxial LEDs at 605 nm, 630 nm, and 660 nm with zero blue light emission). The treatment regimen consisted of: 1. Induction phase: 10 sessions (12 minutes each) over 15 days 2. Maintenance phase: three sessions per week (12 minutes each) for 6 months 3. Setting: performed in outpatient clinic settings under medical/healthcare supervision Sham control arm: Participants underwent an identical treatment schedule (10 induction sessions over 15 days, followed by three weekly sessions for 6 months) using a physically identical device that provided no active PBM therapy. Treatment duration: 6 months. Follow-up evaluations: baseline, 1 month and 6 months. Assessments included BCVA (ETDRS), microperimetry (macular integrity assessment [MAIA] for macular response stability and full threshold), optical coherence tomography macular thickness, intraocular pressure, and a patient-reported usability/comfort questionnaire. |
| Intervention type | Device |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Jupiter TM |
| Primary outcome measure(s) |
|
| Key secondary outcome measure(s) | |
| Completion date | 20/03/2025 |
Eligibility
| Participant type(s) | |
|---|---|
| Age group | Mixed |
| Lower age limit | 50 Years |
| Upper age limit | 101 Years |
| Sex | All |
| Target sample size at registration | 48 |
| Total final enrolment | 45 |
| Key inclusion criteria | 1.Age ≥50 years 2. Early, intermediate and late dry AMD (AREDS1) 3. Best corrected visual acuity (BCVA) 50–75 ETDRS letters 4. Microperimetry sensitivity 5–25 dB 5. Ability to comply with home treatment 6. Written informed consent |
| Key exclusion criteria | 1. Neovascular AMD 2. Significant media opacities (cataract, posterior capsule opacification) 3. Recent ocular surgery 4. Glaucoma with field loss 5. Diabetic macular edema 6. Uveitis or photosensitivity 7. Severe systemic disease 8. Participation in another trial within 3 months |
| Date of first enrolment | 08/01/2023 |
| Date of final enrolment | 29/09/2024 |
Locations
Countries of recruitment
- Italy
Study participating centres
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|
Editorial Notes
24/09/2026: Study's existence confirmed by the Low Vision Academy Scientific Ethics Committee.
