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Phase 4 IOP Signals Associated With ILUVIEN® (PALADIN)
This study is ongoing, but not recruiting participants.
Sponsor:
Alimera Sciences
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
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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
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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
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