A Non-Randomized, Open-Label, Single Center Phase 4 Study of the Effect and Safety of ILUVIEN® in Chronic Diabetic Macular Edema Patients Considered Insufficiently Responsive to Available Therapies (Laser, Anti-VEGF) With or Without Intravitreal Corticosteroid Therapy

Inclusion Criteria

• Patients ≥18 years of age, of either sex that have signed informed consent / been well informed by the treating physician.
• DME based on investigator's clinical evaluation and demonstrated using fundoscopic photography and spectral domain OCT.
• Mean central foveal thickness (central subfield thickness) ≥350 microns in the study eye as measured using spectral domain OCT.
• Vision impairment (20/60 to 20/400 using Snellen visual acuity equivalent) related to DME.
• Previous treatment in the study eye with laser photocoagulation for DME, including focal/grid and pan-retinal, at least 3 months prior to the screening visit and ≥3 monthly anti-VEGF treatments (group 1).
• Previous treatment in the study eye with laser photocoagulation for DME at least 3 months prior to the screening visit (group 2) and treatment with an intraocular anti-VEGF therapy not possible.
• Patients considered as insufficiently responsive to prior therapy for DME, as defined by the study physician.

Exclusion Criteria

• IOP >21 mmHg at screening in the study eye.
• Historical rise in IOP >25 mmHg following treatment with an intravitreal corticosteroid in the study eye.
• Use of ≥2 IOP-lowering medications to control IOP at screening in the study eye.
• Patients that have vitreomacular traction in DME and opaque media in the study eye.
• Patients with severe proliferative diabetic retinopathy requiring pan retinal photocoagulation in the study eye.
• Pregnant or breastfeeding.
• Patients diagnosed with active angiographic central vein ischaemia prior to screening in the study eye.
• Patients that have received pan retinal photocoagulation or undergone cataract surgery in the 3 months prior to the study start date in the study eye.
• Patients with contraindications according to the current SPC:
• The presence of pre-existing glaucoma.
• Active or suspected ocular or periocular infection.
• The patient is hypersensitive to the active agent or to one of the excipients.