Photobiomodulation for the Treatment of Diabetic Macular Edema
Status:
Completed
Trial end date:
2019-08-30
Target enrollment:
Participant gender:
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.