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

Phase 4

Completed

• Conditions: Chronic Diabetic Macular Edema
• Interventions: Drug: ILUVIEN

• Registration Number: NCT02472366
• Lead Sponsor: Alimera Sciences

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2014-01
• Primary Completion: 2015-03
• Study Completion: 2015-05
• Study First Submitted: 2015-06-10
• Study First Submitted QC: 2015-06-12
• Study First Posted: 2015-06-15
• Results First Submitted: 2015-06-23
• Status Verified: 2015-08
• Results First Submitted QC: 2015-08-14
• Last Update Submitted: 2015-08-14
• Results First Posted: 2015-09-16
• Last Update Posted: 2015-09-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
laser	ILUVIEN	laser with or without prior history of intraocular corticosteroid therapy
laser and anti-VEGF	ILUVIEN	laser and anti-VEGF therapy with or without prior history of intraocular corticosteroid therapy

Primary Outcome Measures

Name	Time	Method
Changes in Best Corrected Visual Acuity From Baseline	Change from Baseline to 12 months post ILUVIEN administration	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.

Secondary Outcome Measures

Name	Time	Method
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