Fluocinolone Acetonide Insert (ILUVIEN®) for Diabetic Macular Edema (FAD) Study (FAD)

August 21, 2017 updated by: Johns Hopkins University

Primary Objective:

• To collect post-approval safety data related to intraocular pressure (IOP) after one or more injections of Iluvien as standard of care in subjects with diabetic macular edema (DME).

Secondary Objectives:

• To collect visual and anatomic outcome data after one or more injections of Iluvien as standard of care in subjects with diabetic macular edema (DME).

Study Overview

Status

Withdrawn

Intervention / Treatment

Detailed Description

Diabetic retinopathy (DR) is a major complication of diabetes mellitus that can lead to significant visual morbidity. Important features of DR are microaneurysms, vascular leakage, vascular occlusion, and retinal neovascularization. Diabetic macular edema (DME) occurs when there is leakage in the macula, the central region of the retina that is responsible for fine visual acuity. DME is the most prevalent cause of moderate visual loss in patients with diabetes.(1)

Treatment options for DME include the use of focal/grid laser photocoagulation (2), intravitreal anti-VEGF therapy (3-5), intravitreal steroid therapy (6) and steroid implant insertion into the vitreous cavity (7-9).

Corticosteroids are known to be beneficial in the treatment of DME by reducing the expression of vascular endothelial growth factor (VEGF) and other inflammatory cytokines e.g. Interleukin-6, which play a major role in pathogenesis of DME. (10).

Iluvien® (Alimera Sciences, Inc., Alpharetta, GA) is a low dose, sustained release corticosteroid insert that has recently been FDA approved for use in patients with DME. (10, 11) Structurally it is a nonbiodegradable, cylindrical polymer tube measuring 3.5x0.37 mm which releases 0.19 µg/day of Fluocinolone Acetonide. These inserts are injected into the vitreous cavity in an outpatient setting through a 25-gauge injector system which uses MedidurTM (Alimera Sciences, Inc.) technology and are found to be beneficial compared to sham treatment for up to 3 years. (10, 11) As a complication steroid implants can sometimes result in a dose dependent elevation in the intraocular pressure (IOP) which can increase the risk of glaucoma in susceptible patients. The purpose of this study is to look at post-approval safety data related to IOP after one or more injections of Iluvien as standard of care in subjects with DME.

Objectives

Primary Objective:

• To collect post-approval safety data related to intraocular pressure (IOP) after one or more injections of Iluvien as standard of care in subjects with diabetic macular edema (DME).

Secondary Objectives:

• To collect visual and anatomic outcome data after one or more injections of Iluvien as standard of care in subjects with diabetic macular edema (DME).

Study Procedures

This study will assess the long term safety, visual, and anatomic outcomes in subjects receiving 1 or more injections of Iluvien as standard care for DME. Fifty patients from the clinic population of the Wilmer Eye Institute will be enrolled in the study for a duration of 60 months. Subjects will have a measurement of best corrected visual acuity (BCVA), IOP and eye exam at baseline and months 12, 24, 36, 48, and 60. All other follow up and all treatment will be in the clinic by the patient's treating physician. Data from the clinic notes will be collected on case report forms and adverse events will be documented.

Study Type

Interventional

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

    • Maryland
      • Baltimore, Maryland, United States, 21218
        • Wilmer Eye Institute, Johns Hopkins University School of Medicine

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:

  • Subjects receiving Iluvien as standard of care for DME
  • Understands the procedures and requirements of the study and provides written informed consent and authorization for protected health information disclosure.

Exclusion Criteria:

• None

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
Patients will receive Iluvien as the standard of care treatment for diabetic macular edema.
Other Names:
  • Fluocinolone Acetonide Intravitreal Implant 0.19 mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of patients that require a surgical procedure for increased IOP that could not be controlled by IOP-lowering drops.
Time Frame: 5 years
Percentage of patients that require a surgical procedure for increased intraocular pressure that could not be controlled by IOP-lowering drops.
5 years
Percentage of patients requiring 1, 2, or 3 medications to control IOP.
Time Frame: 5 years
Percentage of patients requiring 1, 2, or 3 medications to control intraocular pressure.
5 years
Percentage of patients with IOP > 25mmHg on two occasions and percentage of patients with IOP > 30mmHg on two occasions
Time Frame: 5 years
Percentage of patients with intraocular pressure > 25mmHg on two occasions and percentage of patients with intraocular pressure > 30mmHg on two occasions
5 years
Percentage of patients losing > 15 letters at month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60
Time Frame: 5 years
Percentage of patients losing > 15 letters at month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60
5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean change from baseline BCVA ETDRS letter score at months 12, 24, 36, 48, and 60
Time Frame: 5 years
Mean change from baseline best corrected visual acuity (BCVA) ETDRS letter score at months 12, 24, 36, 48, and 60
5 years
Mean change from baseline CST measured by spectral domain-optical coherence tomography (SD-OCT) at months 12, 24, 36, 48, and 60
Time Frame: 5 years
Mean change from baseline central subfield thickness (CST) measured by spectral domain-optical coherence tomography (SD-OCT) at months 12, 24, 36, 48, and 60
5 years
Percentage of subjects with gain from baseline BCVA letter score ≥ 15; ≥ 10; ≥ 5 at months 12, 24, 36, 48, and 60
Time Frame: 5 years
Percentage of subjects with gain from baseline best corrected visual acuity (BCVA) letter score ≥ 15; ≥ 10; ≥ 5 at months 12, 24, 36, 48, and 60
5 years
Percentage of subjects with CST ≤300µm at months 12, 24, 36, 48, and 60
Time Frame: 5 years
Percentage of subjects with central subfield thickness (CST) ≤300µm at months 12, 24, 36, 48, and 60
5 years
Percentage of subjects with no intraretinal or subretinal fluid in the macula at months 12, 24, 36, 48, and 60
Time Frame: 5 years
Percentage of subjects with no intraretinal or subretinal fluid in the macula at months 12, 24, 36, 48, and 60
5 years
Number of anti-VEGF injections required between baseline and month 60
Time Frame: 5 years
Number of anti-VEGF injections required between baseline and month 60
5 years

Collaborators and Investigators

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

Investigators

  • Study Director: Gulnar Hafiz, MD, MPH, Wilmer Eye Institute, Johns Hopkins Hospital

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)

March 1, 2017

Primary Completion (Actual)

August 18, 2017

Study Completion (Actual)

August 18, 2017

Study Registration Dates

First Submitted

September 12, 2016

First Submitted That Met QC Criteria

September 12, 2016

First Posted (Estimate)

September 16, 2016

Study Record Updates

Last Update Posted (Actual)

August 22, 2017

Last Update Submitted That Met QC Criteria

August 21, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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