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
Condition: Chronic Diabetic Macular Edema
MeSH terms: Macular Edema; Edema
Intervention: ILUVIEN
Intervention MeSH terms: Fluocinolone Acetonide
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 16.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

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

Eligibility criteria:

        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.