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Diabetic Macular Edema (DME)Phase 4PALADINNCT02424019

Phase 4 IOP Signals Associated With ILUVIEN®

A Phase 4 study testing ILUVIEN 0.19 MG in people with Diabetic Macular Edema (DME), run by Alimera Sciences at 41 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Any age
Conditions the study is for
Diabetic Macular Edema (DME)
What is being tested?
ILUVIEN 0.19 MG
Could I receive a placebo?
No, everyone receives an active treatment
How many people
153 participants
Where
41 sitesUnited States
Study dates
6 May 2015to 31 Jul 2020
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Patients who are eligible for treatment with ILUVIEN based on the Prescribing Information.

Who cannot join

  • Patients who are unable to understand and sign the Informed Consent Form.

Trial locations and contacts

41 sites in 1 country.

41 sites in 1 country

United States41 sites

  • Retina Consultants of Hawaii

    ‘Aiea, Hawaii, 96701

  • Southeast Retina Center, P.C.

    Augusta, Georgia, 30909

  • Retina Research Center

    Austin, Texas, 78705

  • University of Maryland Eye Associates

    Baltimore, Maryland, 21201

  • Johns Hopkins Hospital

    Baltimore, Maryland, 21287

  • Joseph R. Podhorzer, MD PLLC

    Brooklyn, New York, 11223

  • Laurel Eye Clinic

    Brookville, Pennsylvania

  • Pennsylvania Retina Specialist, PC

    Camp Hill, Pennsylvania, 17011

  • Hampton Roads Retina Center

    Chesapeake, Virginia, 23320

  • Lifelong Vision Foundation

    Chesterfield, Missouri, 63017

  • Chicagoland Eye and Retina Foundation

    Chicago, Illinois, 60601

  • The University of Illinois at Chicago

    Chicago, Illinois, 60612

  • Wayne State University

    Detroit, Michigan, 48201

  • Retina and Macula Institute

    Glendale, California, 91203

  • Atlantis Eye Care

    Huntington Beach, California, 92647

  • Discover Vision Centers

    Independence, Missouri, 64055

  • Southeastern Retina Associates, PC

    Kingsport, Tennessee, 37660

  • Sabates Eye Center Research Division

    Leawood, Kansas, 66211

  • Eye Care Center of Northern Colorado

    Longmont, Colorado, 80503

  • Ophthalmic Consultants of Long Island

    Lynbrook, New York, 11563

  • Valley Retina Institute, PA

    McAllen, Texas, 78503

  • Northern California Retina Vitreous Medical Group, Inc.

    Mountain View, California

  • New Jersey Retina

    New Brunswick, New Jersey, 08901

  • Macula Care

    New York, New York, 10021

  • University Retina and Macula Associates

    Oak Forest, Illinois, 63017

  • Illinois Retina Associates, SC

    Oak Park, Illinois, 60304

  • Paducah Retinal Center

    Paducah, Kentucky, 42001

  • Retina Consultants of Arizona

    Phoenix, Arizona, 85014

  • Eyesight Ophthalmic Services, PA

    Portsmouth, New Hampshire, 03801

  • Medical Center Ophthalmology Associates

    San Antonio, Texas

  • Orange County Retina Medical Group

    Santa Ana, California, 92705

  • Island Retina

    Shirley, New York

  • Retina Vitreous Associates of Florida

    St. Petersburg, Florida

  • Retina Associates of New Jersey

    Teaneck, New Jersey, 07666

  • Retina Centers, P.C.

    Tucson, Arizona, 85704

  • Tulsa Retina Consultants

    Tulsa, Oklahoma, 74133

  • Cascade Eye and Skin

    University Place, Washington, 98467

  • Carle Foundation Hospital

    Urbana, Illinois, 61801

  • Virginia Retina Center

    Warrenton, Virginia, 20186

  • Wolfe Eye Clinic

    West Des Moines, Iowa, 50266

  • Eye Associates of Northeast Louisiana

    West Monroe, Louisiana, 71291

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
ILUVIEN 0.19 MG

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ILUVIEN 0.19 MGDrug

    Also called Fluocinolone Acetonide Intravitreal Implant 0.19 mg

Study groups in NCT02424019
Study groupRoleWhat they receive
ILUVIEN 0.19 MGExperimentalAll patients will receive ILUVIEN (Fluocinolone Acetonide Intravitreal Insert) 0.19 mg.
Receives: Drug: ILUVIEN 0.19 MG

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Intraocular Pressure

    Intraocular pressure of the ILUVIEN treated eye

    Measured: 36 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Apr 2015 (estimated)
  2. Study start6 May 2015
  3. Primary completion29 Jul 2020
  4. Study completion31 Jul 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
153 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02424019
Sponsor's protocol ID
M-01-15-004
Acronym
PALADIN
Status last verified
Jan 2022
First submitted
18 Apr 2015
Last updated
11 Jan 2022
Results posted
No
Data monitoring committee
No

Publications

  • Eichenbaum D, Gonzalez VH, Roth D, Fortun J, Radcliffe NM, Cutino A, Kasper J, Coughlin BA, Arevalo JF. Ocular, Visual, and Anatomical Outcomes in Eyes Requiring Incisional Intraocular Pressure-Lowering Surgery Following the 0.19-mg Fluocinolone Acetonide Intravitreal Implant. Ophthalmic Surg Lasers Imaging Retina. 2024 Jan;55(1):22-23. doi: 10.3928/23258160-20231109-02. Epub 2024 Jan 1.

    PubMed 38189802

  • 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.

    PubMed 32461262

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing ILUVIEN 0.19 MG in people with Diabetic Macular Edema (DME), run by Alimera Sciences at 41 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 41 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Intraocular Pressure (time frame: 36 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02424019, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2022.

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