Phase 4 IOP Signals Associated With ILUVIEN®

Diabetic Macular Edema (DME) Clinical Trial

— PALADIN  

Official title:

A Phase 4 Safety Study of IOP Signals in Patients Treated With ILUVIEN® (Fluocinolone Acetonide Intravitreal Implant) 0.19 mg

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02424019
• Other study ID #: M-01-15-004
• Status: Completed
• Phase: Phase 4
• Start date: May 6, 2015
• Est. completion date: July 31, 2020

Study information

• Verified date: January 2022
• Source: Alimera Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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 information / eligibility

• Status: Completed
• Enrollment: 153
• Est. completion date: July 31, 2020
• Est. primary completion date: July 29, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetic Macular Edema (DME)
• Macular Edema

Intervention

Drug:
• ILUVIEN 0.19 MG

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Alimera Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intraocular Pressure	Intraocular pressure of the ILUVIEN treated eye	36 months