Safety, Tolerability, and Short-Term Efficacy of Low-Level Light Therapy for Dry Age-Related Macular Degeneration

NCT06046118 | Not reported | Borrelli E et al. (2024)

Borrelli, E., Coco, G., Pellegrini, M., Mura, M., Ciarmatori, N., Scorcia, V., et al. Safety, Tolerability, and Short-Term Efficacy of Low-Level Light Therapy for Dry Age-Related Macular Degeneration. Ophthalmology Therapy, 2024; -:1-16.

Locations

Five centers in Europe (Italy and Turkey)

Study Period

Not reported

Study Design

Randomized, double-masked, sham-controlled trial

Study Population

Characteristic:

Type of AMD:

1 (Dry AMD)

AMD Stage:

2 (Intermediate) and 1 (Early)

Total Sample Size:

76 patients (152 eyes) randomized into PBM (76 eyes) and sham (76 eyes) groups

Age:

Randomized, double-masked, sham-controlled trial

Sex (Male) n%:

18 (23.7%)

Experimental Group

Intervention Therapy:

Photobiomodulation (PBM) using EYE-LIGHT® system

Dose & Frequency:

Two sessions per week for four weeks

Age (Years):

68.6 ± 9.2

Number of Patients:

38 (76 eyes)

Male N %:

6 (15.8%)

Patients Followed Up:

Control Group

Intervention Therapy:

Sham PBM (low power light exposure)

Dose & Frequency:

Two sessions per week for four weeks

Age (Years):

68.6 ±11.3

Number of Patients:

38 (76 eyes)

Male N %:

12 (31.6%)

Patients Followed Up:

Follow-up Time: 4 months

Outcomes

Durability

N/A

Vision

Best-Corrected Visual Acuity (BCVA)
Mean BCVA change at Month 4:
• PBM = +0.48 ± 5.31 letters
• Sham = -1.13 ± 5.00 letters
• Difference = 1.61 letters (95% CI: 0.19 to 3.03, p = 0.026).

Proportion of Patients Gaining ≥5 Letters
At Month 4:
• PBM: 20.3%
• Sham: 8.9%
• Difference = 11.4% (95% CI: 0.39 to 22.41, p = 0.043).

Other

Tolerability
Mean BODI score
• PBM: 1.6 ± 2.5
• Sham: 1.22 ± 2.0
• Difference: p = 0.50
Compliance
Overall, all patients (100%) of both the sham and PBM groups were fully compliant with all treatment sessions.

Immunognicity

Not reported

Pharmokinetics

Not reported

Anatomic

Drusen Volume
Mean drusen volume change at Month 4:
• PBM = -0.97 ± 16.74 mm³
• Sham = +0.25 ± 5.20 mm³
• Difference = -1.22 mm³ (95% CI: -2.19 to -0.25, p = 0.013).

Change in Central Subfield Thickness (CST)
Mean CST change at Month 4:
• PBM = -2.5 ± 18.6 µm
• Sham = -1.2 ± 16.3 µm
• Difference = -1.3 µm (95% CI: -5.4 to 2.8, p = 0.63).

Safety

AEs (Primary outcome)
Note: Wilcoxon rank‑sum test or the Fisher’s exact test for comparison.
The number of eyes with ocular‑specific AEs :
• PBM: 19.7%
• Sham: 40.8%
• Difference: p = 0.008
Dry eye‑like symptoms:
• PBM: 7.9%
• Sham: 9.2%
• Difference: p = 1.0
Warmth at the application site:
• PBM: 10.5%
• Sham: 22.4%
• Difference: p = 0.079
Visual perseveration:
• PBM: 3.9%
• Sham: 11.8%
• Difference: p = 0.130

Study Discontinuation due to AEs
3 patients in Sham group due to macular neovascular membrane (MNV) (p = 0.240).

Outcomes

Conclusion

PBM treatment using the EYE-LIGHT® system was safe, well tolerated, and showed short-term functional and anatomical benefits in dAMD patients.

Risk of Bias Assessment for Primary Outcome

Randomization Process

Some concerns

Note: No information on the methods on randomization and the allocation concealment. However, “No statistically significant differences between the sham and the PBM groups were found…”

Missing Outcome Data

Low risk

Note: The primary outcomes were assessed by full population set.

Selection of the Reported Results

Low risk Note: Registration with the protocol.

Deviations from Intended Observations

Low risk Note: This is a double masked study. The primary outcomes (safety etc.) were assessed by full population set.

Measurement of the Outcome

Low risk Note: This is a double masked study. The assessment is consistent with he two groups for the primary outcomes.

Overall

Some concerns