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

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.

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