Phase 4 IOP Signals Associated With ILUVIEN® (PALADIN)

January 10, 2022 updated by: Alimera Sciences

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

153

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85014
        • Retina Consultants of Arizona
      • Tucson, Arizona, United States, 85704
        • Retina Centers, P.C.
    • California
      • Glendale, California, United States, 91203
        • Retina and Macula Institute
      • Huntington Beach, California, United States, 92647
        • Atlantis Eye Care
      • Mountain View, California, United States
        • Northern California Retina Vitreous Medical Group, Inc.
      • Santa Ana, California, United States, 92705
        • Orange County Retina Medical Group
    • Colorado
      • Longmont, Colorado, United States, 80503
        • Eye Care Center of Northern Colorado
    • Florida
      • Saint Petersburg, Florida, United States
        • Retina Vitreous Associates of Florida
    • Georgia
      • Augusta, Georgia, United States, 30909
        • Southeast Retina Center, P.C.
    • Hawaii
      • 'Aiea, Hawaii, United States, 96701
        • Retina Consultants Of Hawaii
    • Illinois
      • Chicago, Illinois, United States, 60612
        • The University of Illinois at Chicago
      • Chicago, Illinois, United States, 60601
        • Chicagoland Eye and Retina Foundation
      • Oak Forest, Illinois, United States, 63017
        • University Retina and Macula Associates
      • Oak Park, Illinois, United States, 60304
        • Illinois Retina Associates, SC
      • Urbana, Illinois, United States, 61801
        • Carle Foundation Hospital
    • Iowa
      • West Des Moines, Iowa, United States, 50266
        • Wolfe Eye Clinic
    • Kansas
      • Leawood, Kansas, United States, 66211
        • Sabates Eye Center Research Division
    • Kentucky
      • Paducah, Kentucky, United States, 42001
        • Paducah Retinal Center
    • Louisiana
      • West Monroe, Louisiana, United States, 71291
        • Eye Associates of Northeast Louisiana
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Johns Hopkins Hospital
      • Baltimore, Maryland, United States, 21201
        • University of Maryland Eye Associates
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Wayne State University
    • Missouri
      • Chesterfield, Missouri, United States, 63017
        • Lifelong Vision Foundation
      • Independence, Missouri, United States, 64055
        • Discover Vision Centers
    • New Hampshire
      • Portsmouth, New Hampshire, United States, 03801
        • Eyesight Ophthalmic Services, PA
    • New Jersey
      • New Brunswick, New Jersey, United States, 08901
        • New Jersey Retina
      • Teaneck, New Jersey, United States, 07666
        • Retina Associates of New Jersey
    • New York
      • Brooklyn, New York, United States, 11223
        • Joseph R. Podhorzer, MD PLLC
      • Lynbrook, New York, United States, 11563
        • Ophthalmic Consultants of Long Island
      • New York, New York, United States, 10021
        • Macula Care
      • Shirley, New York, United States
        • Island Retina
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74133
        • Tulsa Retina Consultants
    • Pennsylvania
      • Brookville, Pennsylvania, United States
        • Laurel Eye Clinic
      • Camp Hill, Pennsylvania, United States, 17011
        • Pennsylvania Retina Specialist, PC
    • Tennessee
      • Kingsport, Tennessee, United States, 37660
        • Southeastern Retina Associates, PC
    • Texas
      • Austin, Texas, United States, 78705
        • Retina Research Center
      • McAllen, Texas, United States, 78503
        • Valley Retina Institute, PA
      • San Antonio, Texas, United States
        • Medical Center Ophthalmology Associates
    • Virginia
      • Chesapeake, Virginia, United States, 23320
        • Hampton Roads Retina Center
      • Warrenton, Virginia, United States, 20186
        • Virginia Retina Center
    • Washington
      • University Place, Washington, United States, 98467
        • Cascade Eye and Skin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ILUVIEN 0.19 MG
All patients will receive ILUVIEN (Fluocinolone Acetonide Intravitreal Insert) 0.19 mg.
Drug: ILUVIEN 0.19 MG
Other Names:
  • Fluocinolone Acetonide Intravitreal Implant 0.19 mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intraocular Pressure
Time Frame: 36 months
Intraocular pressure of the ILUVIEN treated eye
36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alimera Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 6, 2015

Primary Completion (Actual)

July 29, 2020

Study Completion (Actual)

July 31, 2020

Study Registration Dates

First Submitted

April 18, 2015

First Submitted That Met QC Criteria

April 21, 2015

First Posted (Estimate)

April 22, 2015

Study Record Updates

Last Update Posted (Actual)

January 11, 2022

Last Update Submitted That Met QC Criteria

January 10, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M-01-15-004

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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