LumiThera Presents Valeda Treatment Benefits for Photobiomodulation in Early Patients with Diabetic Retinopathy and Macular Edema
SEATTLE, May 7, 2021 /PRNewswire/ -- LumiThera Inc., a commercial stage medical device company delivering photobiomodulation (PBM) treatment for ocular damage and diseases, today announced research investigators lead by Drs. Hakan Kaymak, Inken Becker and Hartmut Schwahn, from the Macula Retina Centre of Breyer Kaymak & Klabe Eye Clinic in Dusseldorf, Germany presented positive clinical findings following PBM treatment with the Valeda Light Delivery System from an ongoing safety and efficacy study in Early Diabetic Retinopathy (DR) Patients with Central Macular Edema (DME) at the Association for Research in Vision and Ophthalmology Conference 2021.
This is the first retrospective systematic evaluation with the Valeda system in early DR/DME patients with good vision. The study investigated the beneficial effects of Valeda PBM on both objective and subjective visual function in early DME patients. A total of 30 eyes from 19 DME patients (56 ± 14 yrs, range: 27-76, 68% male) with good visual acuity (VA) and macula edema were treated with one series of 9 PBM treatments (about 3 times a week for 3 to 4 weeks).
The patients were assessed for multiple clinical, anatomical and safety outcomes. Wide field color fundus photography (Optos) prior to and after PBM treatment was assessed using diabetes retinopathy severity scale (DRSS) by an independent retinal expert. Optical Coherence Tomography (Zeiss) imaging assessments and patients´ subjective evaluations (via questionnaire) were conducted before PBM treatments at baseline (BL), after final treatment and at follow-up visits that extended up to 16 months.
"The results demonstrate the first time Valeda was tested in DME patients and showed improvement in both anatomical and clinical outcomes," stated Hakan Kaymak, MD. "Previously, we have demonstrated the clinical benefits of PBM treatments in dry AMD patients in our clinic. Now we have extended the safety and effectiveness into early DME patients with good vision."
After the Valeda treatment, the presence of intraretinal fluid (IRF) overall was reduced from 90% to 70% (p = 0.031). Presence of IRF in the central 1 mm reduced from 70% to 57% (p = 0.125). Hard exudates were present at BL and were significantly reduced by the PBM treatment from 66.7% to 46.7% (p = 0.031). Central Retinal Thickness at BL was 294 ± 51 µm and significantly reduced to 286 ± 42 µm (p = 0.027). After 9 PBM treatments the DRSS scores showed a 1 step improvement in 17% of the eyes, in 83% the DRSS score remained stable. More than 60% of the patients treated with one series of PBM for 3 to 4 weeks noted a continuation of their subjective improvement and a decreased disease influence on their daily life 4 months after the PBM treatments.