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Phase 4 IOP Signals Associated With ILUVIEN®

Phase 4
Completed
Conditions
Diabetic Macular Edema (DME)
Interventions
Registration Number
NCT02424019
Lead Sponsor
Alimera Sciences
Brief Summary

This study will assess the safety in patients treated with ILUVIEN, with primary focus on IOP.

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
153
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.

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
ILUVIEN 0.19 MGILUVIEN 0.19 MGAll patients will receive ILUVIEN (Fluocinolone Acetonide Intravitreal Insert) 0.19 mg.
Primary Outcome Measures
NameTimeMethod
Intraocular Pressure36 months

Intraocular pressure of the ILUVIEN treated eye

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (41)

Retina Consultants of Arizona

🇺🇸

Phoenix, Arizona, United States

Retina Centers, P.C.

🇺🇸

Tucson, Arizona, United States

Retina and Macula Institute

🇺🇸

Glendale, California, United States

Atlantis Eye Care

🇺🇸

Huntington Beach, California, United States

Northern California Retina Vitreous Medical Group, Inc.

🇺🇸

Mountain View, California, United States

Orange County Retina Medical Group

🇺🇸

Santa Ana, California, United States

Eye Care Center of Northern Colorado

🇺🇸

Longmont, Colorado, United States

Retina Vitreous Associates of Florida

🇺🇸

Saint Petersburg, Florida, United States

Southeast Retina Center, P.C.

🇺🇸

Augusta, Georgia, United States

Retina Consultants of Hawaii

🇺🇸

'Aiea, Hawaii, United States

Scroll for more (31 remaining)
Retina Consultants of Arizona
🇺🇸Phoenix, Arizona, United States

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