@article {1619429,
	title = {A Randomized Trial of Photobiomodulation Therapy for Center-Involved Diabetic Macular Edema with Good Visual Acuity (Protocol AE)},
	journal = {Ophthalmol Retina},
	volume = {6},
	number = {4},
	year = {2022},
	month = {2022 Apr},
	pages = {298-307},
	abstract = {PURPOSE: To determine if treatment with a photobiomodulation (PBM) device results in greater improvement in central subfield thickness (CST) than placebo in eyes with center-involved diabetic macular edema (CI-DME) and good vision. DESIGN: Phase 2 randomized clinical trial. PARTICIPANTS: Participants had CI-DME and visual acuity (VA) 20/25 or better in the study eye and were recruited from 23 clinical sites in the United States. METHODS: One eye of each participant was randomly assigned 1:1 to a 670-nm light-emitting PBM eye patch or an identical device emitting broad-spectrum white light at low power. Treatment was applied for 90 seconds twice daily for 4 months. MAIN OUTCOME MEASURES: Change in CST on spectral-domain OCT at 4 months. RESULTS: From April 2019 to February 2020, 135 adults were randomly assigned to either PBM (n\&nbsp;= 69) or placebo (n\&nbsp;= 66); median age was 62 years, 37\% were women, and 82\% were White. The median device compliance was 92\% with PBM and 95\% with placebo. OCT CST increased from baseline to 4 months by a mean (SD) of 13 (53) μm in PBM eyes and 15 (57) μm in placebo eyes, with the mean difference (95\% confidence interval [CI]) being\&nbsp;-2 (-20 to 16) μm (P\&nbsp;= 0.84). CI-DME, based on DRCR Retina Network sex- and machine-based thresholds, was present in 61 (90\%) PBM eyes and 57 (86\%) placebo eyes at 4 months (adjusted odds ratio [95\% CI]\&nbsp;= 1.30 (0.44-3.83); P\&nbsp;= 0.63). VA decreased by a mean (SD) of\&nbsp;-0.2 (5.5) letters and\&nbsp;-0.6 (4.6) letters in the PBM and placebo groups, respectively (difference [95\% CI]\&nbsp;= 0.4 (-1.3 to 2.0) letters; P\&nbsp;= 0.64). There were 8 adverse events possibly related to the PBM device and 2 adverse events possibly related to the placebo device. None were serious. CONCLUSIONS: PBM as given in this study, although safe and well-tolerated, was not found to be effective for the treatment of CI-DME in eyes with good vision.},
	keywords = {Adult, Angiogenesis Inhibitors, Clinical Trials, Phase II as Topic, Diabetes Mellitus, Diabetic Retinopathy, Female, Humans, Low-Level Light Therapy, Macular Edema, Male, Middle Aged, Randomized Controlled Trials as Topic, Tomography, Optical Coherence, Visual Acuity},
	issn = {2468-6530},
	doi = {10.1016/j.oret.2021.10.003},
	author = {Kim, Judy E and Glassman, Adam R and Josic, Kristin and Melia, Michele and Aiello, Lloyd P and Baker, Carl and Eells, Janis T and Jampol, Lee M and Kern, Timothy S and Marcus, Dennis and Salehi-Had, Hani and Shah, Sandeep N and Martin, Daniel F and Stockdale, Cynthia R and Sun, Jennifer K and DRCR Retina Network}
}
