Phase 4 IOP Signals Associated With ILUVIEN® (PALADIN)
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ClinicalTrials.gov Identifier: NCT02424019 |
Recruitment Status
:
Active, not recruiting
First Posted
: April 22, 2015
Last Update Posted
: January 10, 2018
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Diabetic Macular Edema (DME) | Drug: ILUVIEN 0.19 MG | Phase 4 |
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 |
Study Start Date : | April 2015 |
Estimated Primary Completion Date : | December 2019 |
Estimated Study Completion Date : | December 2019 |

Arm | Intervention/treatment |
---|---|
Experimental: ILUVIEN 0.19 MG
All patients will receive ILUVIEN (Fluocinolone Acetonide Intravitreal Insert) 0.19 mg.
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Drug: ILUVIEN 0.19 MG
Other Name: Fluocinolone Acetonide Intravitreal Implant 0.19 mg
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- Intraocular Pressure [ Time Frame: 36 months ]Intraocular pressure of the ILUVIEN treated eye

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Ages Eligible for Study: | Child, Adult, Senior |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

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

Study Chair: | Kenneth Green | Alimera Sciences |
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 10, 2018 |
Last Verified: | January 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 |