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 : Completed
First Posted : April 22, 2015
Last Update Posted : January 11, 2022
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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)|
|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|
|Actual Primary Completion Date :||July 29, 2020|
|Actual Study Completion Date :||July 31, 2020|
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
- Intraocular Pressure [ Time Frame: 36 months ]Intraocular pressure of the ILUVIEN treated eye
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|Ages Eligible for Study:||Child, Adult, Older Adult|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Patients who are eligible for treatment with ILUVIEN based on the Prescribing Information.
- 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
|Responsible Party:||Alimera Sciences|
|Other Study ID Numbers:||
|First Posted:||April 22, 2015 Key Record Dates|
|Last Update Posted:||January 11, 2022|
|Last Verified:||January 2022|
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs