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Phase 4 IOP Signals Associated With ILUVIEN® (PALADIN)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Alimera Sciences
ClinicalTrials.gov Identifier:
NCT02424019
First received: April 18, 2015
Last updated: January 5, 2017
Last verified: January 2017
  Purpose
This study will assess the safety in patients treated with ILUVIEN, with primary focus on IOP.

Condition Intervention Phase
Diabetic Macular Edema (DME) Drug: ILUVIEN® Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
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

Resource links provided by NLM:


Further study details as provided by Alimera Sciences:

Primary Outcome Measures:
  • Intraocular Pressure [ Time Frame: 36 months ]

Enrollment: 153
Study Start Date: April 2015
Estimated Study Completion Date: December 2019
Estimated Primary Completion Date: December 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: ILUVIEN 0.19 MG
All patients will receive ILUVIEN (Fluocinolone Acetonide Intravitreal Insert) 0.19 mg.
Drug: ILUVIEN®
Other Name: Fluocinolone Acetonide Intravitreal Implant 0.19 mg

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.
  Eligibility

Ages Eligible for Study:   Child, Adult, Senior
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02424019

  Show 41 Study Locations
Sponsors and Collaborators
Alimera Sciences
  More Information

Responsible Party: Alimera Sciences
ClinicalTrials.gov Identifier: NCT02424019     History of Changes
Other Study ID Numbers: M-01-15-004
Study First Received: April 18, 2015
Last Updated: January 5, 2017

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on August 22, 2017