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

• Status: Completed
• Trial end date: 2016-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Association for Innovation and Biomedical Research on Light and Image
• Treatments: Fluocinolone Acetonide

Criteria

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.