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Diabetic Macular EdemaPhase 4FADNCT02902744

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

A Phase 4 study testing ILUVIEN® in people with Diabetic Macular Edema, run by Johns Hopkins University at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

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). Read more about this study

Who is it for?
Any age
Conditions the study is for
Diabetic Macular Edema
What is being tested?
ILUVIEN®
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteUnited States
Study dates
1 Mar 2017to 18 Aug 2017
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

  • 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.

Who cannot join

  • None

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Wilmer Eye Institute, Johns Hopkins University School of Medicine

    Baltimore, Maryland, 21218

Other trials in United States

About this study

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).
Read the 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.

Being tested
ILUVIEN®

What participants receive

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

  • ILUVIEN®Drug

    Also called Fluocinolone Acetonide Intravitreal Implant 0.19 mg

    Patients will receive Iluvien as the standard of care treatment for diabetic macular edema.

Study groups in NCT02902744
Study groupRoleWhat they receive
ILUVIEN 0.19 MGExperimentalNot described
Receives: Drug: ILUVIEN®

What is being measured

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

  1. Percentage of patients that require a surgical procedure for increased IOP that could not be controlled by IOP-lowering drops.

    Percentage of patients that require a surgical procedure for increased intraocular pressure that could not be controlled by IOP-lowering drops.

    Measured: 5 years

  2. Percentage of patients requiring 1, 2, or 3 medications to control IOP.

    Percentage of patients requiring 1, 2, or 3 medications to control intraocular pressure.

    Measured: 5 years

  3. Percentage of patients with IOP > 25mmHg on two occasions and percentage of patients with IOP > 30mmHg on two occasions

    Percentage of patients with intraocular pressure > 25mmHg on two occasions and percentage of patients with intraocular pressure > 30mmHg on two occasions

    Measured: 5 years

  4. Percentage of patients losing > 15 letters at month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60

    Percentage of patients losing > 15 letters at month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60

    Measured: 5 years

Secondary outcomes (6)

  1. Mean change from baseline BCVA ETDRS letter score at months 12, 24, 36, 48, and 60

    Mean change from baseline best corrected visual acuity (BCVA) ETDRS letter score at months 12, 24, 36, 48, and 60

    Measured: 5 years

  2. Mean change from baseline CST measured by spectral domain-optical coherence tomography (SD-OCT) at months 12, 24, 36, 48, and 60

    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

    Measured: 5 years

  3. Percentage of subjects with gain from baseline BCVA letter score ≥ 15; ≥ 10; ≥ 5 at months 12, 24, 36, 48, and 60

    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

    Measured: 5 years

  4. Percentage of subjects with CST ≤300µm at months 12, 24, 36, 48, and 60

    Percentage of subjects with central subfield thickness (CST) ≤300µm at months 12, 24, 36, 48, and 60

    Measured: 5 years

  5. Percentage of subjects with no intraretinal or subretinal fluid in the macula at months 12, 24, 36, 48, and 60

    Percentage of subjects with no intraretinal or subretinal fluid in the macula at months 12, 24, 36, 48, and 60

    Measured: 5 years

  6. Number of anti-VEGF injections required between baseline and month 60

    Number of anti-VEGF injections required between baseline and month 60

    Measured: 5 years

Timeline

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

  1. First posted16 Sep 2016 (estimated)
  2. Study start1 Mar 2017
  3. Primary completion18 Aug 2017
  4. Study completion18 Aug 2017

Why it stopped: The study was withdrawn due to difficult recruitment of patients for the study; No participants were enrolled in the study.

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
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02902744
Sponsor's protocol ID
IRB00082826
Acronym
FAD
Status last verified
Aug 2017
First submitted
12 Sep 2016
Last updated
22 Aug 2017
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing ILUVIEN® in people with Diabetic Macular Edema, run by Johns Hopkins University at 1 site 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 2 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: withdrawn, as of the sponsor's last update on 22 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 was withdrawn before enrolling participants, so there are no results.

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?

Percentage of patients that require a surgical procedure for increased IOP that could not be controlled by IOP-lowering drops. (time frame: 5 years). The study lists 4 primary outcomes in all. 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 NCT02902744.

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 22 Aug 2017.

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