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NCT02424019 Clinical Trial

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
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
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
Health authority
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.

Study Design

Related Conditions & MeSH terms

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
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