NCT02359526

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)

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Association for Innovation and Biomedical Research on Light and Image · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Diabetic Macular Edema

Interventions

Type	Name	Description
DRUG	IlUVIEN	All patients will receive ILUVIEN 190 micrograms intravitreal implant in applicator with an initial release rate of 0.2 microgram per day. The implant will be administered by injection according to the method of administration defined in the SmPC (ILUVIEN SmPC). Only one eye of each patient will be treated with ILUVIEN.

Timeline

• Start date: 2014-10-01
• Primary completion: 2016-03-01
• Completion: 2016-12-01
• First posted: 2015-02-10
• Last updated: 2017-03-10

Locations

4 sites across 1 country: Portugal