A multicentre phase III randomised controlled single-masked clinical trial evaluating the cl inical e fficacy and safety o f light-masks at p reventing dark-a daptation in the tr eatment of ea rly…

A multicentre phase III randomised controlled single-masked clinical trial evaluating the cl inical e fficacy and safety o f light-masks at p reventing dark-a daptation in the tr eatment of ea rly diabetic macular oedema (CLEOPATRA): study protocol for a randomised controlled trial

Trials, November 2014

25417120

Sobha Sivaprasad, Geoffrey Arden, A Toby Prevost, Roxanne Crosby-Nwaobi, Helen Holmes, Joanna Kelly, Caroline Murphy, Gary Rubin, Joanna Vasconcelos, Philip Hykin

This study will evaluate hypoxia, as a novel concept in the pathogenesis of diabetic macular oedema (DMO). As the oxygen demand of the eye is maximum during dark-adaptation, we hypothesize that wearing light-masks during sleep will cause regression and prevent the development and progression of DMO. The study protocol comprises both an efficacy and mechanistic evaluation to test this hypothesis.Method/Design: This is a phase III randomised controlled single-masked multicentre clinical trial to test the clinical efficacy of light-masks at preventing dark-adaptation in the treatment of non-central DMO. Three hundred patients with non-centre-involving DMO in at least one eye will be randomised 1:1 to light-masks and control masks (with no light) to be used during sleep at night for a period of 24 months. The primary outcome is regression of non-central oedema by assessing change in the zone of maximal retinal thickness at baseline on optical coherence tomography (SD-OCT). Secondary outcomes will evaluate the prevention of development and progression of DMO by assessing changes in retinal thickness in different regions of the macula, macular volume, refracted visual acuity and level of retinopathy. Safety parameters will include sleep disturbance. Adverse events and measures of compliance will be assessed over 24 months. Participants recruited to the mechanistic sub-study will have additional retinal oximetry, multifocal electroretinography (ERG) and microperimetry to evaluate the role of hypoxia by assessing and comparing changes induced by supplemental oxygen and the light-masks at 12 months.