A Randomized Trial of Photobiomodulation Therapy for Center-Involved Diabetic Macular Edema with Good Visual Acuity (Protocol AE).

PubMed ID: 34628066

Author(s): Kim JE, Glassman AR, Josic K, Melia M, Aiello LP, Baker C, Eells JT, Jampol LM, Kern TS, Marcus D, Salehi-Had H, Shah SN, Martin DF, Stockdale CR, Sun JK; DRCR Retina Network. A randomized trial of photobiomodulation therapy for center-involved diabetic macular edema with good visual acuity (protocol AE). Ophthalmol Retina. 2022 Apr;6(4):298-307. doi: 10.1016/j.oret.2021.10.003. Epub 2021 Oct 8. PMID 34628066

Journal: Ophthalmology. Retina, Volume 6, Issue 4, Apr 2022

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 = 69) or placebo (n = 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 -2 (-20 to 16) μm (P = 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] = 1.30 (0.44-3.83); P = 0.63). VA decreased by a mean (SD) of -0.2 (5.5) letters and -0.6 (4.6) letters in the PBM and placebo groups, respectively (difference [95% CI] = 0.4 (-1.3 to 2.0) letters; P = 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.