Non-invasive Treatment of Early Diabetic Macular Edema by Multi-Wavelength Photobiomodulation with the Valeda Light Delivery System

Abstract

Purpose : The complex pathophysiology of DME results in extracellular fluid accumulation and in decreased visual function. Light-based Photobiomodulation (PBM) provides a non-invasive treatment strategy that directly targets the underlying pathology through light-sensitive cellular cascades. The Valeda Light Delivery System is successful in the treatment of AMD (cf. LIGHTSITE I & II). We here present an observation of novel PBM therapy in early DME patients with the Valeda System.

Methods : A total of 28 eyes from 18 DME patients (67% male; 57.3±14.0 yrs) withgood vision but OCT evidence of macula edema were assessed for functional (BCVA), anatomical (CRT, RV, presence of IRF, SRF and HE), and safety outcomes (integrity of EZ, IZ, ELM and RPE) following one series of PBM treatments (3x per week for 3-4 weeks) with the Valeda Light Delivery System. Assessments were conducted at baseline (BL), immediately following the final (9th) treatment and at follow up visits out to approx. 6 months. Presence of ERM, VMT and DRIL in the OCT and patients' subjective evaluations (via questionnaire) were recorded as well.

Results : After initial treatment with PBM, 28.6 % and 40 % eyes showed a resolution of inner retinal fluid and hard exudates, respectively. Retinal thickness (CRT) remained stable, from 302±58 µm at BL to 296±47 µm after 9th treatment. In all eyes, photoreceptors and RPE remained intact during the treatment and up to 6 months follow-up. At the same time, visual acuity remained stable at 0.1±0.1 logMAR. Most patients noted a considerable improvement in their subjective vision and reported less problems in everyday life and were more confident and more positively biased towards the development of the disease even up to 6 months.

Conclusions : Anatomical benefits suggest disease-modifying effect with PBM treatment with the Valeda in early DME patients. These study subjects typically had good vision and nearly normal CRT and RV but clear evidence of macular edema. PBM treatment demonstrates potential as a novel, non-invasive, cost-effective and well-tolerated approach for treatment of early DME patients. Moreover, the early treatment may provide a viable option to stabilize the functional and anatomical parameters and prevent the progression of the DME disease.

This is a 2021 ARVO Annual Meeting abstract.