Clinical trial NCT02424019: Phase 4 IOP Signals Associated With ILUVIEN®
Official title: A Phase 4 Safety Study of IOP Signals in Patients Treated With ILUVIEN® (Fluocinolone Acetonide Intravitreal Implant) 0.19 mg
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetic Macular Edema (DME)
Lead sponsor: Alimera Sciences
Sponsor class: INDUSTRY
First posted: 2015-04-22
Enrollment: 153
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Intraocular Pressure
timeFrame: 36 months
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Retina Consultants of Arizona
state: Arizona
city: Tucson
country: United States
facility: Retina Centers, P.C.
state: Arizona
city: Glendale
country: United States
facility: Retina and Macula Institute
state: California
city: Huntington Beach
country: United States
facility: Atlantis Eye Care
state: California
city: Mountain View
country: United States
facility: Northern California Retina Vitreous Medical Group, Inc.
state: California
city: Santa Ana
country: United States
facility: Orange County Retina Medical Group
state: California
city: Longmont
country: United States
facility: Eye Care Center of Northern Colorado
state: Colorado
city: Saint Petersburg
country: United States
facility: Retina Vitreous Associates of Florida
state: Florida
city: Augusta
country: United States
facility: Southeast Retina Center, P.C.
state: Georgia
city: 'Aiea
country: United States
facility: Retina Consultants of Hawaii
state: Hawaii
city: Chicago
country: United States
facility: Chicagoland Eye and Retina Foundation
state: Illinois
city: Chicago
country: United States
facility: The University of Illinois at Chicago
state: Illinois
city: Oak Forest
country: United States
facility: University Retina and Macula Associates
state: Illinois
city: Oak Park
country: United States
facility: Illinois Retina Associates, SC
state: Illinois
city: Urbana
country: United States
facility: Carle Foundation Hospital
state: Illinois
city: West Des Moines
country: United States
facility: Wolfe Eye Clinic
state: Iowa
city: Leawood
country: United States
facility: Sabates Eye Center Research Division
state: Kansas
city: Paducah
country: United States
facility: Paducah Retinal Center
state: Kentucky
city: West Monroe
country: United States
facility: Eye Associates of Northeast Louisiana
state: Louisiana
city: Baltimore
country: United States
facility: University of Maryland Eye Associates
state: Maryland
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
city: Detroit
country: United States
facility: Wayne State University
state: Michigan
city: Chesterfield
country: United States
facility: Lifelong Vision Foundation
state: Missouri
city: Independence
country: United States
facility: Discover Vision Centers
state: Missouri
city: Portsmouth
country: United States
facility: Eyesight Ophthalmic Services, PA
state: New Hampshire
city: New Brunswick
country: United States
facility: New Jersey Retina
state: New Jersey
city: Teaneck
country: United States
facility: Retina Associates of New Jersey
state: New Jersey
city: Brooklyn
country: United States
facility: Joseph R. Podhorzer, MD PLLC
state: New York
city: Lynbrook
country: United States
facility: Ophthalmic Consultants of Long Island
state: New York
city: New York
country: United States
facility: Macula Care
state: New York
city: Shirley
country: United States
facility: Island Retina
state: New York
city: Tulsa
country: United States
facility: Tulsa Retina Consultants
state: Oklahoma
city: Brookville
country: United States
facility: Laurel Eye Clinic
state: Pennsylvania
city: Camp Hill
country: United States
facility: Pennsylvania Retina Specialist, PC
state: Pennsylvania
city: Kingsport
country: United States
facility: Southeastern Retina Associates, PC
state: Tennessee
city: Austin
country: United States
facility: Retina Research Center
state: Texas
city: McAllen
country: United States
facility: Valley Retina Institute, PA
state: Texas
city: San Antonio
country: United States
facility: Medical Center Ophthalmology Associates
state: Texas
city: Chesapeake
country: United States
facility: Hampton Roads Retina Center
state: Virginia
city: Warrenton
country: United States
facility: Virginia Retina Center
state: Virginia
city: University Place
country: United States
facility: Cascade Eye and Skin
state: Washington
Study officials:
References:
citation: 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.