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

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.

Study Overview

• Status: Terminated
• Conditions: Diabetic Macular Edema (DME)

• Study Type: Observational
• Enrollment (Actual): 25

Contacts and Locations

Study Locations

• Germany
  • Neubrandenburg, Germany

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with DME considered insufficiently responsive to available therapies in approximately 25 ophthalmology centers (private practice or hospital) across Germany

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Chronic DME; Patients with vision impairment associated with chronic diabetic macular edema (DME)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Acuity	Observed and change from baseline visual acuity LogMAR scores will be summarized using descriptive statistics.	24 Months
Number of Patients With Ocular Adverse Events		24 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Retinal Center Subfield Thickness	Observed and change from baseline SD-OCT values will be summarized using descriptive statistics.	24 months

Collaborators and Investigators

• Sponsor: Alimera Sciences
• Investigators: Study Chair: Professor Helmut Hoeh, MD, Dietrich-Bonhoeffer-Klinikum

Study record dates

Study Major Dates

• Study Start: December 1, 2013
• Primary Completion (Actual): March 1, 2015
• Study Completion (Actual): April 1, 2015

Study Registration Dates

• First Submitted: March 3, 2014
• First Submitted That Met QC Criteria: March 4, 2014
• First Posted (Estimate): March 6, 2014

Study Record Updates

• Last Update Posted (Estimate): August 26, 2015
• Last Update Submitted That Met QC Criteria: August 14, 2015
• Last Verified: August 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Retinal Degeneration; Retinal Diseases; Macular Degeneration; Macular Edema
• Other Study ID Numbers: M-01-13-003

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No