For full access to the article: https://doi.org/10.1136/bjo-2025-328389
Abstract
Background Dry age-related macular degeneration (AMD) is the leading cause of irreversible vision loss in older adults, with no approved treatment to modify progression in early and intermediate stages. Photobiomodulation (PBM), which targets mitochondrial dysfunction and retinal inflammation, has shown promise in early studies. This study aims to evaluate the anatomical and functional efficacy of PBM in eyes with early and intermediate dAMD.
Methods In this 12-month, multicentre, randomised double-masked controlled trial, 138 eyes from 78 patients with early or intermediate dAMD were included. The primary outcome was change in mean drusen volume (MDV) from baseline to 12 months. Secondary outcomes included change in best-corrected visual acuity (BCVA) and adverse events. Multilevel mixed-effects regression was used to analyse treatment-time interactions.
Results MDV decreased significantly in the PBM group (–0.03±0.05 mm³) while increased in the sham group (+0.02 ± 0.04 mm³; p<0.001) at 12 months. The PBM group also showed a significant improvement in BCVA (+1.31 ± 6.7 letters) compared with a decline in the sham group (–2.62±7.1 letters), yielding a between-group difference of +3.75 letters (95% CI 1.16 to 6.34; p=0.0001). Female sex and higher Age-Related Eye Disease Study (AREDS) category were associated with MDV increase over time (p=0.030 and p=0.003; respectively), while older age was associated with MDV reduction (p=0.049). Four eyes in the sham group developed macular neovascularisation, compared with none in the PBM group (p=0.044), while one eye in the PBM group developed geographic atrophy (p=1.00). No cases of retinal phototoxicity were observed.
Conclusion PBM significantly reduced drusen burden and improved visual function in early and intermediate dAMD over 12 months, with an excellent safety profile. These findings support PBM as a promising therapeutic option for patients with non-neovascular age-related macular degeneration, despite further studies with longer follow-up are needed to confirm the role of PBM in potentially slowing the natural course of the disease.
Summary :
Study: Iovino et al., BJO 2026, 12-month multicentre randomized double-masked controlled trial
Device: EYE-LIGHT® PBM / LLLT - LED
Wavelengths: 590 nm yellow + 630 nm red
Mode: continuous and pulsed
Irradiance: not confirmed from accessible article text; requires full methods/device specification or author/device-manufacturer confirmation
The study included 138 eyes from 78 patients with early or intermediate dry AMD. Patients were randomized to receive either PBM treatment or sham treatment, and both patients and examiners were masked.
The primary endpoint was change in mean drusen volume (MDV) from baseline to 12 months. Secondary outcomes included best-corrected visual acuity (BCVA) and adverse events.
Main anatomical result: drusen volume
The PBM group showed a reduction in mean drusen volume, while the sham group showed an increase.
|
Outcome |
PBM group |
Sham group |
Significance |
|
Mean drusen volume at 12 months |
−0.03 ± 0.05 mm³ |
+0.02 ± 0.04 mm³ |
p < 0.001 |
Interpretation: PBM was associated with a statistically significant reduction in drusen burden over 12 months compared with sham treatment.
Main functional result: visual acuity
The PBM group had a modest improvement in BCVA, while the sham group lost letters.
|
Outcome |
PBM group |
Sham group |
Between-group difference |
|
BCVA change |
+1.31 ± 6.7 letters |
−2.62 ± 7.1 letters |
+3.75 letters |
|
Statistical result |
95% CI 1.16 to 6.34; p = 0.0001 |
Interpretation: PBM produced a statistically significant visual acuity advantage of approximately 3.75 ETDRS letters compared with sham. This is clinically modest but directionally favourable.
Disease progression events
The study reported fewer neovascular conversion events in the PBM group.
|
Progression event |
PBM group |
Sham group |
Significance |
|
Macular neovascularisation |
0 eyes |
4 eyes |
p = 0.044 |
|
Geographic atrophy |
1 eye |
Not statistically different |
p = 1.00 |
|
Retinal phototoxicity |
0 cases |
0 cases |
— |
Interpretation: No PBM-treated eyes developed macular neovascularization during the study period, compared with four sham-treated eyes. This is interesting but should be interpreted cautiously because the number of events was small.
Safety
No cases of retinal phototoxicity were observed. The authors described the safety profile as excellent over the 12-month study period.
Risk-factor findings
The regression analysis found that:
|
Factor |
Association |
|
Female sex |
Associated with increased MDV over time |
|
Higher AREDS category |
Associated with increased MDV over time |
|
Older age |
Associated with MDV reduction over time |
These are secondary analytic findings and should not be overinterpreted without reviewing the full paper.
Bottom-line summary
This study suggests that PBM may have produced both anatomical and functional benefits in early and intermediate dry AMD over 12 months:
- Reduced drusen volume
- Improved BCVA relative to sham
- No observed retinal phototoxicity
- Fewer macular neovascularisation events in the PBM group
- One geographic atrophy event in the PBM group
- Authors conclude PBM is a promising therapeutic option, but longer follow-up studies are needed.