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

NCT02080091 | Terminated Results

• 1 other identifier: M-01-13-003
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Diabetic Macular Edema (DME)

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Retinal Center Subfield Thickness

  24 months

Study Arms (1)

Chronic DME

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Alimera Sciences: lead

Study Sites (1)

Unknown Facility

Neubrandenburg, Germany

Location

Results Point of Contact

• Title: Andrew Joyson - Associate Director, Clinical Operations Europe
• Organization: Alimera Sciences, Ltd.

Andrew.Joyson@alimerasciences.com

+44 1252 354 026

Study Officials

• Professor Helmut Hoeh, MD

  Dietrich-Bonhoeffer-Klinikum

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2014
• First Posted: March 6, 2014
• Study Start: December 1, 2013
• Primary Completion: March 1, 2015
• Study Completion: April 1, 2015
• Last Updated: August 26, 2015
• Results First Posted: August 10, 2015

Record last verified: 2015-08

Locations

DE (1)