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

Alimera Sciences

Status: Terminated

Conditions: Diabetic Macular Edema (DME)

Study type: Observational

Funder types: Industry

Identifiers

NCT02080091

M-01-13-003

Details and patient eligibility

About

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.

Enrollment: 25 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

25 participants in 1 patient group

Chronic DME

Description:

Patients with vision impairment associated with chronic diabetic macular edema (DME)