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Iluvien Registry Safety Study (IRISS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01998412
Recruitment Status : Active, not recruiting
First Posted : November 28, 2013
Last Update Posted : March 20, 2019
Sponsor:
Information provided by (Responsible Party):
Alimera Sciences

Brief Summary:
The study will include any patient treated with Iluvien at designated sites in European countries where marketing authorization has been granted in order to obtain broader safety and usage information.

Condition or disease
Chronic Diabetic Macular Oedema Considered Insufficiently Responsive to Available Therapies

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Study Type : Observational [Patient Registry]
Actual Enrollment : 559 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
Official Title: An Open Label, Registry Study of the Safety of Iluvien® 190 Micrograms Intravitreal Implant in Applicator
Study Start Date : December 2013
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : January 2020

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Number of participants with adverse events. [ Time Frame: 5 years ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with vision impairment associated with chronic diabetic macular oedema considered insufficiently responsive to available therapies that were selected to be treated with an intravitreal implant of ILUVIEN.
Criteria

Inclusion Criteria:

  • Any patient treated with Iluvien under this protocol will be included in the study.

Exclusion Criteria:

  • Patients/Guardians who are unable to understand and sign the Informed Consent will be excluded from the study.

Retrospective Enrollment Criteria

Patients treated with ILUVIEN prior to study initiation may be included provided they satisfy the inclusion and exclusion criteria, where applicable, as well as, the following requirements:

  1. The site is allowed to enroll a patient who was treated with ILUVIEN no more than 36 months prior to bringing the patient in for their first study visit.
  2. The eligible patient must meet the data requirements as specified in the protocol, i.e., baseline data collected within 7 days prior to treatment with ILUVIEN and additional data subsequently collected approximately every 6 months thereafter until enrolment into the study.
  3. The eligible patient must be enrolled at least one year prior to the planned end of the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01998412


Locations
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United States, Georgia
Atlanta, Georgia, United States
Sponsors and Collaborators
Alimera Sciences

Additional Information:
Publications of Results:
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Responsible Party: Alimera Sciences
ClinicalTrials.gov Identifier: NCT01998412    
Other Study ID Numbers: M-01-12-001
First Posted: November 28, 2013    Key Record Dates
Last Update Posted: March 20, 2019
Last Verified: March 2019
Additional relevant MeSH terms:
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Macular Edema
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Fluocinolone Acetonide
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs