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Phase 4 IOP Signals Associated With ILUVIEN® (PALADIN)

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: NCT02424019
Recruitment Status : Active, not recruiting
First Posted : April 22, 2015
Last Update Posted : January 23, 2019
Sponsor:
Information provided by (Responsible Party):
Alimera Sciences

Study Description
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Brief Summary:
This study will assess the safety in patients treated with ILUVIEN, with primary focus on IOP.

Condition or disease Intervention/treatment Phase
Diabetic Macular Edema (DME) Drug: ILUVIEN 0.19 MG Phase 4

Detailed Description:
The specific objectives include the study of intraocular pressure (IOP) related data in patients who received ILUVIEN and how it relates to the patient's experiences following prior treatment with a course of corticosteroid which did not result in a clinically significant IOP elevation.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 153 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 4 Safety Study of IOP Signals in Patients Treated With ILUVIEN® (Fluocinolone Acetonide Intravitreal Implant) 0.19 mg
Actual Study Start Date : May 6, 2015
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : January 2020

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Arms and Interventions
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Arm Intervention/treatment
Experimental: ILUVIEN 0.19 MG
All patients will receive ILUVIEN (Fluocinolone Acetonide Intravitreal Insert) 0.19 mg.
 Drug: ILUVIEN 0.19 MG
Other Name: Fluocinolone Acetonide Intravitreal Implant 0.19 mg


Outcome Measures
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Primary Outcome Measures :
  1. Intraocular Pressure [ Time Frame: 36 months ]
    Intraocular pressure of the ILUVIEN treated eye


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients who are eligible for treatment with ILUVIEN based on the Prescribing Information.

Exclusion Criteria:

  • Patients who are unable to understand and sign the Informed Consent Form.
Contacts and Locations
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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): NCT02424019


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Sponsors and Collaborators
Alimera Sciences
Investigators
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Study Chair: Kenneth Green Alimera Sciences
More Information
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Responsible Party: Alimera Sciences
ClinicalTrials.gov Identifier: NCT02424019     History of Changes
Other Study ID Numbers: M-01-15-004
First Posted: April 22, 2015    Key Record Dates
Last Update Posted: January 23, 2019
Last Verified: January 2019

Additional relevant MeSH terms:
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Fluocinolone Acetonide
Macular Edema
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
 Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs