Phase 4 IOP Signals Associated With ILUVIEN®

NCT ID: NCT02424019

Last Updated: 2022-01-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

153 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-05-06

Study Completion Date

2020-07-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Diabetic Macular Edema (DME)

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ILUVIEN 0.19 MG

All patients will receive ILUVIEN (Fluocinolone Acetonide Intravitreal Insert) 0.19 mg.

Group Type EXPERIMENTAL

ILUVIEN 0.19 MG

Intervention Type DRUG

Interventions

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ILUVIEN 0.19 MG

Intervention Type DRUG

Other Intervention Names

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Fluocinolone Acetonide Intravitreal Implant 0.19 mg

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Alimera Sciences

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Retina Consultants of Arizona

Phoenix, Arizona, United States

Site Status

Retina Centers, P.C.

Tucson, Arizona, United States

Site Status

Retina and Macula Institute

Glendale, California, United States

Site Status

Atlantis Eye Care

Huntington Beach, California, United States

Site Status

Northern California Retina Vitreous Medical Group, Inc.

Mountain View, California, United States

Site Status

Orange County Retina Medical Group

Santa Ana, California, United States

Site Status

Eye Care Center of Northern Colorado

Longmont, Colorado, United States

Site Status

Retina Vitreous Associates of Florida

St. Petersburg, Florida, United States

Site Status

Southeast Retina Center, P.C.

Augusta, Georgia, United States

Site Status

Retina Consultants of Hawaii

‘Aiea, Hawaii, United States

Site Status

Chicagoland Eye and Retina Foundation

Chicago, Illinois, United States

Site Status

The University of Illinois at Chicago

Chicago, Illinois, United States

Site Status

University Retina and Macula Associates

Oak Forest, Illinois, United States

Site Status

Illinois Retina Associates, SC

Oak Park, Illinois, United States

Site Status

Carle Foundation Hospital

Urbana, Illinois, United States

Site Status

Wolfe Eye Clinic

West Des Moines, Iowa, United States

Site Status

Sabates Eye Center Research Division

Leawood, Kansas, United States

Site Status

Paducah Retinal Center

Paducah, Kentucky, United States

Site Status

Eye Associates of Northeast Louisiana

West Monroe, Louisiana, United States

Site Status

University of Maryland Eye Associates

Baltimore, Maryland, United States

Site Status

Johns Hopkins Hospital

Baltimore, Maryland, United States

Site Status

Wayne State University

Detroit, Michigan, United States

Site Status

Lifelong Vision Foundation

Chesterfield, Missouri, United States

Site Status

Discover Vision Centers

Independence, Missouri, United States

Site Status

Eyesight Ophthalmic Services, PA

Portsmouth, New Hampshire, United States

Site Status

New Jersey Retina

New Brunswick, New Jersey, United States

Site Status

Retina Associates of New Jersey

Teaneck, New Jersey, United States

Site Status

Joseph R. Podhorzer, MD PLLC

Brooklyn, New York, United States

Site Status

Ophthalmic Consultants of Long Island

Lynbrook, New York, United States

Site Status

Macula Care

New York, New York, United States

Site Status

Island Retina

Shirley, New York, United States

Site Status

Tulsa Retina Consultants

Tulsa, Oklahoma, United States

Site Status

Laurel Eye Clinic

Brookville, Pennsylvania, United States

Site Status

Pennsylvania Retina Specialist, PC

Camp Hill, Pennsylvania, United States

Site Status

Southeastern Retina Associates, PC

Kingsport, Tennessee, United States

Site Status

Retina Research Center

Austin, Texas, United States

Site Status

Valley Retina Institute, PA

McAllen, Texas, United States

Site Status

Medical Center Ophthalmology Associates

San Antonio, Texas, United States

Site Status

Hampton Roads Retina Center

Chesapeake, Virginia, United States

Site Status

Virginia Retina Center

Warrenton, Virginia, United States

Site Status

Cascade Eye and Skin

University Place, Washington, United States

Site Status

Countries

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United States

References

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Mansour SE, Kiernan DF, Roth DB, Eichenbaum D, Holekamp NM, Kaba S, Werts E. Two-year interim safety results of the 0.2 microg/day fluocinolone acetonide intravitreal implant for the treatment of diabetic macular oedema: the observational PALADIN study. Br J Ophthalmol. 2021 Mar;105(3):414-419. doi: 10.1136/bjophthalmol-2020-315984. Epub 2020 May 27.

Reference Type DERIVED
PMID: 32461262 (View on PubMed)

Other Identifiers

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M-01-15-004

Identifier Type: -

Identifier Source: org_study_id

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