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

Diabetic Macular Edema (DME) Clinical Trial

— ILUMINATE  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02080091
• Other study ID #: M-01-13-003
• Status: Terminated
• Phase: N/A
• First received: March 3, 2014
• Last updated: August 14, 2015
• Start date: December 2013
• Est. completion date: April 2015

Study information

• Verified date: August 2015
• Source: Alimera Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 25
• Est. completion date: April 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Diabetic Macular Edema (DME)
• Macular Edema

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Alimera Sciences

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual Acuity	Observed and change from baseline visual acuity LogMAR scores will be summarized using descriptive statistics.	24 Months	Yes
Primary	Number of Patients With Ocular Adverse Events		24 Months	Yes
Secondary	Retinal Center Subfield Thickness	Observed and change from baseline SD-OCT values will be summarized using descriptive statistics.	24 months	No