Clinical trial NCT02457975: Photobiomodulation for the Treatment of Diabetic Macular Edema
Official title: Near-Infrared Photobiomodulation for the Treatment of Diabetic Macular Edema
Conditions: Diabetic Retinopathy
Summary: The current application proposes to conduct a prospective, clinical trial in diabetic subjects with diabetic macular edema (DME) to evaluate the therapeutic efficacy of 670 nm photobiomodulation on validated clinical outcome measures and anatomical changes in central macula by optical coherence tomography (OCT) and other imaging modalities. A total of 30 diabetic patients with treatment-refractory clinically significant diabetic macular edema will be included in this study and randomized into two equal groups. One eye per participant will be included to avoid exposure of both eyes to the study intervention. If both eyes are eligible, the eye with worse visual acuity will become the study eye. One group will be treated with standard-of-care (intravitreal anti-VEGF agent) injections. The photobiomodulaton (PBM) intervention group will be treated with the standard-of-care intravitreal anti-VEGF (vascular endothelial growth factor) injections and 670 nm PBM in one eye. Baseline functional and anatomic assessments will be made and anti-VEGF therapy will be administered as determined by the treating Ophthalmologist.
Interventions:
description: Battery operated, hand-held, 10 cm2 Light Emitting Diode (LED) array designed to deliver 50 mW/cm2 of light for 90 seconds resulting in a light dose of 4.5 Joules/cm2
name: 670nm PBM
other_name: WARP10 by Quantum Devices, Inc (Barneveld, WI)
type: Device
description: Threeintravitreous VEGF inhibitors - aflibercept (Eylea, Regeneron Pharmaceuticals), bevacizumab (Avastin, Genentech), and ranibizumab (Lucentis, Genentech) - are commonly used for the treatment of diabetic macular edema causing vision impairment and have been shown to be beneficial and relatively safe. Study participants in the anti-VEGF group will be treated with intravitreous injections of one of these agents: afibercept (2.0 mg), bevacizumab (1.25 mg) or ranibizumab (0.5 mg) at appropriate intervals as determined by the treating ophthalmologist.
name: intravitreous VEGF-inhibitors
other_name: aflibercept, bevacizumab, or ranibizumab
type: Drug
Study arms:
design_group_description: Three intravitreous VEGF inhibitors - aflibercept (Eylea, Regeneron Pharmaceuticals), bevacizumab (Avastin, Genentech), and ranibizumab (Lucentis, Genentech) - are commonly used for the treatment of diabetic macular edema causing vision impairment and have been shown to be beneficial and relatively safe. Study participants in the anti-VEGF group will be treated with intravitreous injections of one of these agents: afibercept (2.0 mg), bevacizumab (1.25 mg) or ranibizumab (0.5 mg) at appropriate intervals as determined by the treating ophthalmologist.
design_group_title: Intravitreous VEGF-inhibitors
design_group_type: Active Comparator
design_group_description: Subjects in the 670 nm Photobiomodulation (PBM) intervention arm will be treated (in addition to Anti-VEGF treatment) with 670nm light (WARP10, Quantum, Devices, Inc, Barneveld, WI). The portable, battery-operated 670 nm LED array specifically designed not to generate heat will be held 1 inch from the closed treatment eye. A 90-sec light treatment will be delivered. After 90 sec a timer turns off the light. The dose of light delivered at the surface of the cornea is calculated to be 4.5 J/cm2 (90 sec x 0.05 W/cm2 = 4.5 J/cm2). PBM treatment will be applied for 90 sec once per day, three consecutive days per week for 8 weeks. Previous clinical studies, have shown this treatment regimen and dose to be safe and effective in the treatment of dry AMD and non-center involving DME
design_group_title: 670nm PBM plus VEGF-inhibitors
design_group_type: Experimental
Sponsor: Medical College of Wisconsin
Collaborators: University of Wisconsin-Milwaukee
Drug name mappings:
name: 阿柏西普
lang: CN
name: Aflibercept
lang: EN
name: アフリベルセプト（遺伝子組換え）
lang: JP
name: 贝伐珠单抗
lang: CN
name: Bevacizumab
lang: EN
name: ベバシズマブ（遺伝子組換え）
lang: JP