The DRCR Retina Network (DRCR.net ) has found that its Protocol AE, which incorporates the Retilux Eye Patch (PhotoOpTx, LLC), was not effective in treating center-involving diabetic macular edema (CI-DME). In a phase 2, randomized, controlled trial conducted in 135 adults with CI-DME, published online in October by Ophthalmology Retina, the Retilux was compared with a placebo device but did improve central subfield thickness as measured by spectral-domain optical coherence tomography (SD-OCT).

The Retilux photobiomodulation device, which was developed in collaboration with DRCR Retina Network, delivers red light to the affected eye at a wavelength of 670 nm and a dose of 4.5 J/cm². Based on previous findings that light in the far-red to near-infrared area of the spectrum decreased oxidative stress and the expression of proinflammatory proteins in eyes with DME, earlier studies had examined the use of 670-nm light in rodent eyes and in a nonrandomized consecutive case series in human eyes. These studies had found improved vision in a mouse model and a greater reduction in retinal thickness in the human study, which was limited by the lack of randomization and very small size (4 patients).

The authors of the Ophthalmology Retina study conclude that there is insufficient evidence of efficacy to advance the Retilux to phase 3 trials. Nevertheless, the very high compliance rates found in the study for wearing the device suggest that a promising future for wearable devices.