A Non-Randomized, Open-Label, Single Center Phase 4 Study of the Effect and Safety of ILUVIEN® in Chronic Diabetic Macular Edema Patients Considered Insufficiently Responsive to Available Therapies (Laser, Anti-VEGF) With or Without Intravitreal Corticosteroid Therapy

A phase 4 trial evaluating the effect and safety of ILUVIEN in chronic DME patients insufficiently responsive to available therapies.

Study Overview

• Status: Completed
• Conditions: Chronic Diabetic Macular Edema
• Intervention / Treatment: Drug: ILUVIEN

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Patients ≥18 years of age, of either sex that have signed informed consent / been well informed by the treating physician.
2. DME based on investigator's clinical evaluation and demonstrated using fundoscopic photography and spectral domain OCT.
3. Mean central foveal thickness (central subfield thickness) ≥350 microns in the study eye as measured using spectral domain OCT.
4. Vision impairment (20/60 to 20/400 using Snellen visual acuity equivalent) related to DME.
5. Previous treatment in the study eye with laser photocoagulation for DME, including focal/grid and pan-retinal, at least 3 months prior to the screening visit and ≥3 monthly anti-VEGF treatments (group 1).
6. Previous treatment in the study eye with laser photocoagulation for DME at least 3 months prior to the screening visit (group 2) and treatment with an intraocular anti-VEGF therapy not possible.
7. Patients considered as insufficiently responsive to prior therapy for DME, as defined by the study physician.

Exclusion Criteria:

1. IOP >21 mmHg at screening in the study eye.
2. Historical rise in IOP >25 mmHg following treatment with an intravitreal corticosteroid in the study eye.
3. Use of ≥2 IOP-lowering medications to control IOP at screening in the study eye.
4. Patients that have vitreomacular traction in DME and opaque media in the study eye.
5. Patients with severe proliferative diabetic retinopathy requiring pan retinal photocoagulation in the study eye.
6. Pregnant or breastfeeding.
7. Patients diagnosed with active angiographic central vein ischaemia prior to screening in the study eye.
8. Patients that have received pan retinal photocoagulation or undergone cataract surgery in the 3 months prior to the study start date in the study eye.

9. Patients with contraindications according to the current SPC:

   1. The presence of pre-existing glaucoma.
   2. Active or suspected ocular or periocular infection.
   3. The patient is hypersensitive to the active agent or to one of the excipients.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: laser; laser with or without prior history of intraocular corticosteroid therapy	Drug: ILUVIEN
Other: laser and anti-VEGF; laser and anti-VEGF therapy with or without prior history of intraocular corticosteroid therapy	Drug: ILUVIEN

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in Best Corrected Visual Acuity From Baseline	Best Corrected Visual Acuity is measured using an ETDRS eye chart and is reported as the number of letters read correctly in the study and/or fellow eye.	Change from Baseline to 12 months post ILUVIEN administration

Secondary Outcome Measures

Outcome Measure	Time Frame
Changes in Intraocular Pressure (IOP)	Change from Baseline to 12 months post ILUVIEN administration
Changes in Central Subfield Thickness	Change from Baseline to 12 months post ILUVIEN administration
Changes in Macular Volume	Change from Baseline to 12 months post ILUVIEN administration

Collaborators and Investigators

• Sponsor: Alimera Sciences

Study record dates

Study Major Dates

• Study Start: January 1, 2014
• Primary Completion (Actual): March 1, 2015
• Study Completion (Actual): May 1, 2015

Study Registration Dates

• First Submitted: June 10, 2015
• First Submitted That Met QC Criteria: June 12, 2015
• First Posted (Estimate): June 15, 2015

Study Record Updates

• Last Update Posted (Estimate): September 16, 2015
• Last Update Submitted That Met QC Criteria: August 14, 2015
• Last Verified: August 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Retinal Degeneration; Retinal Diseases; Macular Degeneration; Macular Edema; Edema; Physiological Effects of Drugs; Anti-Inflammatory Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Fluocinolone Acetonide
• Other Study ID Numbers: M-01-13-002