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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.
Read More
Exclusion Criteria
  • Patients who are unable to understand and sign the Informed Consent Form.
Read More

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)

University of Maryland Eye Associates

🇺🇸

Baltimore, Maryland, United States

The University of Illinois at Chicago

🇺🇸

Chicago, Illinois, United States

Sabates Eye Center Research Division

🇺🇸

Leawood, Kansas, United States

Virginia Retina Center

🇺🇸

Warrenton, Virginia, United States

Medical Center Ophthalmology Associates

🇺🇸

San Antonio, Texas, United States

Hampton Roads Retina Center

🇺🇸

Chesapeake, Virginia, United States

Retina Centers, P.C.

🇺🇸

Tucson, Arizona, United States

Retina Vitreous Associates of Florida

🇺🇸

Saint Petersburg, Florida, United States

Wayne State University

🇺🇸

Detroit, Michigan, United States

Eye Care Center of Northern Colorado

🇺🇸

Longmont, Colorado, United States

Southeast Retina Center, P.C.

🇺🇸

Augusta, Georgia, United States

Johns Hopkins Hospital

🇺🇸

Baltimore, Maryland, United States

Illinois Retina Associates, SC

🇺🇸

Oak Park, Illinois, United States

Eye Associates of Northeast Louisiana

🇺🇸

West Monroe, Louisiana, United States

Eyesight Ophthalmic Services, PA

🇺🇸

Portsmouth, New Hampshire, United States

Retina Research Center

🇺🇸

Austin, Texas, United States

New Jersey Retina

🇺🇸

New Brunswick, New Jersey, United States

Retina Associates of New Jersey

🇺🇸

Teaneck, New Jersey, United States

Pennsylvania Retina Specialist, PC

🇺🇸

Camp Hill, Pennsylvania, United States

Joseph R. Podhorzer, MD PLLC

🇺🇸

Brooklyn, New York, United States

Macula Care

🇺🇸

New York, New York, United States

Tulsa Retina Consultants

🇺🇸

Tulsa, Oklahoma, United States

Retina Consultants of Arizona

🇺🇸

Phoenix, Arizona, United States

Retina and Macula Institute

🇺🇸

Glendale, California, United States

Atlantis Eye Care

🇺🇸

Huntington Beach, California, United States

Orange County Retina Medical Group

🇺🇸

Santa Ana, California, United States

Retina Consultants of Hawaii

🇺🇸

'Aiea, Hawaii, United States

Chicagoland Eye and Retina Foundation

🇺🇸

Chicago, Illinois, United States

University Retina and Macula Associates

🇺🇸

Oak Forest, Illinois, United States

Wolfe Eye Clinic

🇺🇸

West Des Moines, Iowa, United States

Carle Foundation Hospital

🇺🇸

Urbana, Illinois, United States

Paducah Retinal Center

🇺🇸

Paducah, Kentucky, United States

Discover Vision Centers

🇺🇸

Independence, Missouri, United States

Lifelong Vision Foundation

🇺🇸

Chesterfield, Missouri, United States

Ophthalmic Consultants of Long Island

🇺🇸

Lynbrook, New York, United States

Laurel Eye Clinic

🇺🇸

Brookville, Pennsylvania, United States

Island Retina

🇺🇸

Shirley, New York, United States

Southeastern Retina Associates, PC

🇺🇸

Kingsport, Tennessee, United States

Cascade Eye and Skin

🇺🇸

University Place, Washington, United States

Northern California Retina Vitreous Medical Group, Inc.

🇺🇸

Mountain View, California, United States

Valley Retina Institute, PA

🇺🇸

McAllen, Texas, United States

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