Clinical Ophthalmology (Nov 2023)

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

  • Kaymak H,
  • Munk MR,
  • Tedford SE,
  • Croissant CL,
  • Tedford CE,
  • Ruckert R,
  • Schwahn H

Journal volume & issue
Vol. Volume 17
pp. 3549 – 3559

Abstract

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Hakan Kaymak,1,2 Marion R Munk,3– 5 Stephanie E Tedford,6 Cindy L Croissant,6 Clark E Tedford,6 Rene Ruckert,4,6 Hartmut Schwahn1 1I.I.O.GbR Breyer Kaymak Klabe, Duesseldorf, Germany; 2Experimental Ophthalmology, University Hospital and Medical Faculty of the University of Saarland, Homburg/Saar, Germany; 3Department of Ophthalmology, Inselspital University Hospital Bern, Bern, Switzerland; 4Eyegnos Consulting, Bern, Switzerland; 5Augenarzt-Praxisgemeinschaft Gutblick AG, Pfäffikon, Switzerland; 6LumiThera, Inc, Poulsbo, WA, USACorrespondence: Stephanie E Tedford, LumiThera, Inc, Poulsbo, WA, USA, Email [email protected]: 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

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