A Pilot Study on the Effect and Safety of Iluvien® in Chronic Diabetic Macular Edema Patients

Chronic DME patients considered insufficiently responsive to available therapies (laser, anti-VEGF) with or without intravitreal corticosteroid therapy. Inclusion Criteria: * Adults (≥18 years) with chronic DME; * Patients considered as insufficiently responsive as defined as having underwent other previous treatments, including at least 3 anti-VEGF injections in the last 6 months, and the following: 1. Mean central foveal thickness (central subfield thickness) ≥ 290 um in women and ≥ 305 um in men in Zeiss Cirrus OR ≥ 305 um in women and ≥ 320 um in men in Heidelberg Spectralis, in the study eye as measured using SD-OCT; 2. Vision impairment (20/50 to 20/400 using Snellen visual acuity equivalent) related to DME; 3. If in the Investigator's opinion a further improvement is possible. Exclusion Criteria: * IOP \> 21 mmHg at screening (day -14) in the study eye. * Historical rise in IOP \> 25 mmHg following treatment with an intravitreal corticosteroid in the study eye. * Use of ≥ 2 active agents as IOP-lowering medications to control IOP at screening in the study eye. * Vitreomacular traction in DME and opaque media in the study eye. * Severe proliferative diabetic retinopathy requiring pan retinal photocoagulation in the study eye. * Pregnant or breastfeeding women. * Active angiographic central macular ischaemia before baseline in the study eye. * Pan retinal photocoagulation or cataract surgery 3 months before baseline in the study eye. * Presence of pre-existing glaucoma, active or suspected ocular or periocular infection and/or hypersensitive to the active agent or to one of the excipients. * Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant UNLESS they are: using a highly effective method of birth control.