Non-Invasive Treatment of Early Diabetic Macular Edema by Multiwavelength Photobiomodulation with the Valeda Light Delivery System

Abstract

Purpose

Diabetes is associated with ocular complications including diabetic macular edema (DME). Current therapies are invasive and include repeated intravitreal injections and laser therapy. Photobiomodulation (PBM) is a treatment (Tx) that utilizes selected wavelengths of light to induce cellular benefits including reduction of inflammation and edema. This single-center, open-label, post-hoc analysis explored the utility of multiwavelength PBM in subjects with DME.

Methods

Analysis included review of data from patients undergoing standard clinical care with an approved and marketed PBM medical device, the Valeda^® Light Delivery System. Subjects with early-stage DME with good vision (Best-corrected visual acuity (BCVA) > 20/25, logMAR > 0.1) were evaluated in clinic and treated with one series of multiwavelength PBM (Tx delivered 3x/week over 3–4 weeks; total of 9 Tx sessions). Clinical, anatomical, and safety parameters were assessed in addition to subjective quality of life.

Results

A total of 30 eyes (19 subjects) were analyzed. Subjects were predominately male (68.4%) with a mean age of 56 ± 14 years. Reductions in central retinal thickness (CRT), resolution of intraretinal fluid (IRF) and improvement in diabetic retinopathy severity scale scores were observed following PBM treatment in select patients. Baseline BCVA remained stable over the follow-up observation period of 3 months post-PBM. Approximately 64% of patients reported subjective improvements in their ocular condition and decreased influence in everyday life. Detailed OCT evaluations confirmed no safety issues related to phototoxicity up to 16 months.

Conclusion

Early-stage DME subjects treated with Valeda multiwavelength PBM showed improvements in clinical and anatomical parameters. The Valeda multiwavelength PBM approach demonstrates a favorable safety profile with no signs of phototoxicity following an independent OCT review. PBM therapy may offer an alternative, non-invasive treatment strategy with a unique mechanism and modality for patients with early-stage DME.

Keywords:

• photobiomodulation
• diabetic macular edema
• low level light therapy
• diabetic retinopathy
• central retinal thickness
• Valeda Light Delivery System
• DME
• PBM
• DR
• CRT

Data Sharing Statement

The datasets used and/or analyzed during the current study are available from the corresponding author on reasonable request.

Ethics Approval and Consent to Participate

This case series consisted of a post-hoc analysis of patients undergoing standard clinical care with an approved and marketed medical device. Use of patient data was approved at the local ethic committee (No. 2018124 Äk Nordrhein). As this was a retrospective analysis on consented patient data, the study was not included in a registry. Informed consent was obtained from all subjects. All methods were carried out in accordance with relevant guidelines and regulations. This study complies with the Declaration of Helsinki.

Acknowledgments

The abstract of this paper was presented at the Association for Research in Vision and Ophthalmology Conference as a poster presentation with interim findings. The poster’s abstract was published in “Poster Abstracts” in ARVO Journals: https://iovs.arvojournals.org/article.aspx?articleid=2774919.

Disclosure

HK and HS have received partial funding from LumiThera to support the current research efforts. ST, CLC, MRM, RR and CT are all employed by LumiThera as full-time employees or consultants. The authors report no other conflicts of interest in this work.

Additional information

Funding

There is no funding to report.