Observational Study to Assess the Effect of Iluvien® in DME Patients Insufficiently Responsive to Available Therapies

ILUMINATE: An Open-Label, Non-Interventional Study of the Safety and Effect of Iluvien® (Fluocinolone Acetonide 190 Micrograms Intravitreal Implant in Applicator) in Patients With Chronic Diabetic Macular Edema (DME) Insufficiently Responsive to Available Therapies

This observational study aims to assess the safety and effect of Iluvien® in DME patients considered insufficiently responsive to available therapies in a real life setting in Germany.

Inclusion Criteria:

• Adult patients of both sexes that have signed informed consent after detailed information about the characteristics of the observation by the physician
• DME based on physician's clinical evaluation and demonstrated on fundus photographs and/or optical coherence tomography (OCT);
• Vision impairment associated with DME
• Prior treatment with available therapies for DME; and
• Patients considered by the physician insufficiently responsive to available therapies

Exclusion Criteria:

• Patients with contraindications according to the current Summary of Product Characteristics (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
• Elevated IOP
• Pregnancy or breastfeeding