Phase 4 IOP Signals Associated With ILUVIEN®
PALADIN
A Phase 4 Safety Study of IOP Signals in Patients Treated With ILUVIEN® (Fluocinolone Acetonide Intravitreal Implant) 0.19 mg
1 other identifier
interventional
153
1 country
41
Brief Summary
This study will assess the safety in patients treated with ILUVIEN, with primary focus on IOP.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started May 2015
Longer than P75 for phase_4
41 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 18, 2015
CompletedFirst Posted
Study publicly available on registry
April 22, 2015
CompletedStudy Start
First participant enrolled
May 6, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 29, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
July 31, 2020
CompletedJanuary 11, 2022
January 1, 2022
5.2 years
April 18, 2015
January 10, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Intraocular Pressure
Intraocular pressure of the ILUVIEN treated eye
36 months
Study Arms (1)
ILUVIEN 0.19 MG
EXPERIMENTALAll patients will receive ILUVIEN (Fluocinolone Acetonide Intravitreal Insert) 0.19 mg.
Interventions
Eligibility Criteria
You may qualify if:
- Patients who are eligible for treatment with ILUVIEN based on the Prescribing Information.
You may not qualify if:
- Patients who are unable to understand and sign the Informed Consent Form.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Alimera Scienceslead
Study Sites (41)
Retina Consultants of Arizona
Phoenix, Arizona, 85014, United States
Retina Centers, P.C.
Tucson, Arizona, 85704, United States
Retina and Macula Institute
Glendale, California, 91203, United States
Atlantis Eye Care
Huntington Beach, California, 92647, United States
Northern California Retina Vitreous Medical Group, Inc.
Mountain View, California, United States
Orange County Retina Medical Group
Santa Ana, California, 92705, United States
Eye Care Center of Northern Colorado
Longmont, Colorado, 80503, United States
Retina Vitreous Associates of Florida
St. Petersburg, Florida, United States
Southeast Retina Center, P.C.
Augusta, Georgia, 30909, United States
Retina Consultants of Hawaii
‘Aiea, Hawaii, 96701, United States
Chicagoland Eye and Retina Foundation
Chicago, Illinois, 60601, United States
The University of Illinois at Chicago
Chicago, Illinois, 60612, United States
University Retina and Macula Associates
Oak Forest, Illinois, 63017, United States
Illinois Retina Associates, SC
Oak Park, Illinois, 60304, United States
Carle Foundation Hospital
Urbana, Illinois, 61801, United States
Wolfe Eye Clinic
West Des Moines, Iowa, 50266, United States
Sabates Eye Center Research Division
Leawood, Kansas, 66211, United States
Paducah Retinal Center
Paducah, Kentucky, 42001, United States
Eye Associates of Northeast Louisiana
West Monroe, Louisiana, 71291, United States
University of Maryland Eye Associates
Baltimore, Maryland, 21201, United States
Johns Hopkins Hospital
Baltimore, Maryland, 21287, United States
Wayne State University
Detroit, Michigan, 48201, United States
Lifelong Vision Foundation
Chesterfield, Missouri, 63017, United States
Discover Vision Centers
Independence, Missouri, 64055, United States
Eyesight Ophthalmic Services, PA
Portsmouth, New Hampshire, 03801, United States
New Jersey Retina
New Brunswick, New Jersey, 08901, United States
Retina Associates of New Jersey
Teaneck, New Jersey, 07666, United States
Joseph R. Podhorzer, MD PLLC
Brooklyn, New York, 11223, United States
Ophthalmic Consultants of Long Island
Lynbrook, New York, 11563, United States
Macula Care
New York, New York, 10021, United States
Island Retina
Shirley, New York, United States
Tulsa Retina Consultants
Tulsa, Oklahoma, 74133, United States
Laurel Eye Clinic
Brookville, Pennsylvania, United States
Pennsylvania Retina Specialist, PC
Camp Hill, Pennsylvania, 17011, United States
Southeastern Retina Associates, PC
Kingsport, Tennessee, 37660, United States
Retina Research Center
Austin, Texas, 78705, United States
Valley Retina Institute, PA
McAllen, Texas, 78503, United States
Medical Center Ophthalmology Associates
San Antonio, Texas, United States
Hampton Roads Retina Center
Chesapeake, Virginia, 23320, United States
Virginia Retina Center
Warrenton, Virginia, 20186, United States
Cascade Eye and Skin
University Place, Washington, 98467, United States
Related Publications (1)
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.
PMID: 32461262DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 18, 2015
First Posted
April 22, 2015
Study Start
May 6, 2015
Primary Completion
July 29, 2020
Study Completion
July 31, 2020
Last Updated
January 11, 2022
Record last verified: 2022-01