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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02080091
Other study ID # M-01-13-003
Secondary ID
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


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
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