According to the results of the phase 3 CLEOPATRA trial, patients with non-center-involving diabetic macular edema who wore a light-emitting mask during sleep did not experience long-term therapeutic benefits.
The single-masked, parallel-group, randomized controlled trial included 308 patients with DME randomly assigned to wear either a light mask during sleep (Noctura 400 sleep mask, PolyPhotonix Medical) or a sham non-light mask for 24 months. Researchers examined the change in maximum retinal thickness on OCT from baseline to 24 months.
The study included 155 patients who wore the light mask and 153 who wore the sham mask.
The change in maximum retinal thickness was not statistically significant between the two treatment arms. The mean decrease in retinal thickness in the light mask group was 9.2 µm compared with a decrease of 12.9 µm in the sham mask group.
No serious adverse events were reported with the light mask, but the most frequent adverse event was discomfort reported by 14 patients who wore the light mask and seven patients who wore the sham mask.
“The light mask as offered in this study is not an effective intervention to prevent or treat patients with non-center-involving diabetic macular edema. Future trials should aim to identify better ways of rod suppression to assess the role of rods in diabetic macular edema and diabetic retinopathy,” the study authors said. – by Robert Linnehan
Disclosures: Sivaprasad reports she received research grants, travel grants and speaker fees from and was an advisory board member for Novartis, Bayer, Allergan, Roche, Boehringer Ingelheim and Heidelberg Engineering.