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

A Non-randomised, Open-label, Multicenter Phase 4 Pilot Study on the Effect and Safety of Iluvien® in Chronic Diabetic Macular Edema Patients Considered Insufficiently Responsive to Available Therapies With or Without Intravitreal Corticosteroid Therapy (RESPOND)

To provide treating physicians with experience with ILUVIEN as well as monitoring its safety (and effectiveness) in a real-life chronic diabetic macular edema (DME) patients judged insufficiently responsive to available therapies.

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.