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Phase 4 IOP Signals Associated With ILUVIEN® (PALADIN)

Primary Purpose

Diabetic Macular Edema (DME)

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
ILUVIEN 0.19 MG
Sponsored by
Alimera Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Macular Edema (DME)

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Retina Consultants of Arizona
  • Retina Centers, P.C.
  • Retina and Macula Institute
  • Atlantis Eye Care
  • Northern California Retina Vitreous Medical Group, Inc.
  • Orange County Retina Medical Group
  • Eye Care Center of Northern Colorado
  • Retina Vitreous Associates of Florida
  • Southeast Retina Center, P.C.
  • Retina Consultants of Hawaii
  • Chicagoland Eye and Retina Foundation
  • The University of Illinois at Chicago
  • University Retina and Macula Associates
  • Illinois Retina Associates, SC
  • Carle Foundation Hospital
  • Wolfe Eye Clinic
  • Sabates Eye Center Research Division
  • Paducah Retinal Center
  • Eye Associates of Northeast Louisiana
  • University of Maryland Eye Associates
  • Johns Hopkins Hospital
  • Wayne State University
  • Lifelong Vision Foundation
  • Discover Vision Centers
  • Eyesight Ophthalmic Services, PA
  • New Jersey Retina
  • Retina Associates of New Jersey
  • Joseph R. Podhorzer, MD PLLC
  • Ophthalmic Consultants of Long Island
  • Macula Care
  • Island Retina
  • Tulsa Retina Consultants
  • Laurel Eye Clinic
  • Pennsylvania Retina Specialist, PC
  • Southeastern Retina Associates, PC
  • Retina Research Center
  • Valley Retina Institute, PA
  • Medical Center Ophthalmology Associates
  • Hampton Roads Retina Center
  • Virginia Retina Center
  • Cascade Eye and Skin

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ILUVIEN 0.19 MG

Arm Description

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

Outcomes

Primary Outcome Measures

Intraocular Pressure
Intraocular pressure of the ILUVIEN treated eye

Secondary Outcome Measures

Full Information

First Posted
April 18, 2015
Last Updated
January 10, 2022
Sponsor
Alimera Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT02424019
Brief Title
Phase 4 IOP Signals Associated With ILUVIEN®
Acronym
PALADIN
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

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
May 6, 2015 (Actual)
Primary Completion Date
July 29, 2020 (Actual)
Study Completion Date
July 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alimera Sciences

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Macular Edema (DME)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
153 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ILUVIEN 0.19 MG
Arm Type
Experimental
Arm Description
All patients will receive ILUVIEN (Fluocinolone Acetonide Intravitreal Insert) 0.19 mg.
Intervention Type
Drug
Intervention Name(s)
ILUVIEN 0.19 MG
Other Intervention Name(s)
Fluocinolone Acetonide Intravitreal Implant 0.19 mg
Primary Outcome Measure Information:
Title
Intraocular Pressure
Description
Intraocular pressure of the ILUVIEN treated eye
Time Frame
36 months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Retina Consultants of Arizona
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85014
Country
United States
Facility Name
Retina Centers, P.C.
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85704
Country
United States
Facility Name
Retina and Macula Institute
City
Glendale
State/Province
California
ZIP/Postal Code
91203
Country
United States
Facility Name
Atlantis Eye Care
City
Huntington Beach
State/Province
California
ZIP/Postal Code
92647
Country
United States
Facility Name
Northern California Retina Vitreous Medical Group, Inc.
City
Mountain View
State/Province
California
Country
United States
Facility Name
Orange County Retina Medical Group
City
Santa Ana
State/Province
California
ZIP/Postal Code
92705
Country
United States
Facility Name
Eye Care Center of Northern Colorado
City
Longmont
State/Province
Colorado
ZIP/Postal Code
80503
Country
United States
Facility Name
Retina Vitreous Associates of Florida
City
Saint Petersburg
State/Province
Florida
Country
United States
Facility Name
Southeast Retina Center, P.C.
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30909
Country
United States
Facility Name
Retina Consultants of Hawaii
City
'Aiea
State/Province
Hawaii
ZIP/Postal Code
96701
Country
United States
Facility Name
Chicagoland Eye and Retina Foundation
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60601
Country
United States
Facility Name
The University of Illinois at Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
University Retina and Macula Associates
City
Oak Forest
State/Province
Illinois
ZIP/Postal Code
63017
Country
United States
Facility Name
Illinois Retina Associates, SC
City
Oak Park
State/Province
Illinois
ZIP/Postal Code
60304
Country
United States
Facility Name
Carle Foundation Hospital
City
Urbana
State/Province
Illinois
ZIP/Postal Code
61801
Country
United States
Facility Name
Wolfe Eye Clinic
City
West Des Moines
State/Province
Iowa
ZIP/Postal Code
50266
Country
United States
Facility Name
Sabates Eye Center Research Division
City
Leawood
State/Province
Kansas
ZIP/Postal Code
66211
Country
United States
Facility Name
Paducah Retinal Center
City
Paducah
State/Province
Kentucky
ZIP/Postal Code
42001
Country
United States
Facility Name
Eye Associates of Northeast Louisiana
City
West Monroe
State/Province
Louisiana
ZIP/Postal Code
71291
Country
United States
Facility Name
University of Maryland Eye Associates
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Johns Hopkins Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Wayne State University
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Lifelong Vision Foundation
City
Chesterfield
State/Province
Missouri
ZIP/Postal Code
63017
Country
United States
Facility Name
Discover Vision Centers
City
Independence
State/Province
Missouri
ZIP/Postal Code
64055
Country
United States
Facility Name
Eyesight Ophthalmic Services, PA
City
Portsmouth
State/Province
New Hampshire
ZIP/Postal Code
03801
Country
United States
Facility Name
New Jersey Retina
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08901
Country
United States
Facility Name
Retina Associates of New Jersey
City
Teaneck
State/Province
New Jersey
ZIP/Postal Code
07666
Country
United States
Facility Name
Joseph R. Podhorzer, MD PLLC
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11223
Country
United States
Facility Name
Ophthalmic Consultants of Long Island
City
Lynbrook
State/Province
New York
ZIP/Postal Code
11563
Country
United States
Facility Name
Macula Care
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Island Retina
City
Shirley
State/Province
New York
Country
United States
Facility Name
Tulsa Retina Consultants
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74133
Country
United States
Facility Name
Laurel Eye Clinic
City
Brookville
State/Province
Pennsylvania
Country
United States
Facility Name
Pennsylvania Retina Specialist, PC
City
Camp Hill
State/Province
Pennsylvania
ZIP/Postal Code
17011
Country
United States
Facility Name
Southeastern Retina Associates, PC
City
Kingsport
State/Province
Tennessee
ZIP/Postal Code
37660
Country
United States
Facility Name
Retina Research Center
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
Valley Retina Institute, PA
City
McAllen
State/Province
Texas
ZIP/Postal Code
78503
Country
United States
Facility Name
Medical Center Ophthalmology Associates
City
San Antonio
State/Province
Texas
Country
United States
Facility Name
Hampton Roads Retina Center
City
Chesapeake
State/Province
Virginia
ZIP/Postal Code
23320
Country
United States
Facility Name
Virginia Retina Center
City
Warrenton
State/Province
Virginia
ZIP/Postal Code
20186
Country
United States
Facility Name
Cascade Eye and Skin
City
University Place
State/Province
Washington
ZIP/Postal Code
98467
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
32461262
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.
Results Reference
derived

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Phase 4 IOP Signals Associated With ILUVIEN®

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