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

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

Conditions
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Chronic Diabetic Macular Edema

Intervention / Treatment
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* Drug: ILUVIEN


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients ≥18 years of age, of either sex that have signed informed consent / been well informed by the treating physician. DME based on investigator's clinical evaluation and demonstrated using fundoscopic photography and spectral domain OCT. Mean central foveal thickness (central subfield thickness) ≥350 microns in the study eye as measured using spectral domain OCT. Vision impairment (20/60 to 20/400 using Snellen visual acuity equivalent) related to DME. 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). 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. Patients considered as insufficiently responsive to prior therapy for DME, as defined by the study physician. Exclusion Criteria: IOP >21 mmHg at screening in the study eye. Historical rise in IOP >25 mmHg following treatment with an intravitreal corticosteroid in the study eye. Use of ≥2 IOP-lowering medications to control IOP at screening in the study eye. Patients that have vitreomacular traction in DME and opaque media in the study eye. Patients with severe proliferative diabetic retinopathy requiring pan retinal photocoagulation in the study eye. Pregnant or breastfeeding. Patients diagnosed with active angiographic central vein ischaemia prior to screening in the study eye. 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. Patients with contraindications according to the current SPC: The presence of pre-existing glaucoma. Active or suspected ocular or periocular infection. The patient is hypersensitive to the active agent or to one of the excipients.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 | Measure Description | 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 |