Clinical trial NCT02472366: 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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Chronic Diabetic Macular Edema
Lead sponsor: Alimera Sciences
Sponsor class: INDUSTRY
First posted: 2015-06-15
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Primary outcomes:
measure: Changes in Best Corrected Visual Acuity From Baseline
timeFrame: Change from Baseline to 12 months post ILUVIEN administration
Secondary outcomes:
measure: Changes in Intraocular Pressure (IOP)
timeFrame: Change from Baseline to 12 months post ILUVIEN administration
measure: Changes in Central Subfield Thickness
timeFrame: Change from Baseline to 12 months post ILUVIEN administration
measure: Changes in Macular Volume
timeFrame: Change from Baseline to 12 months post ILUVIEN administration
Other outcomes:
Locations:
Study officials:
References: