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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02472366

Enrollment

Registered

2015-06-15

Start date

2014-01-31

Completion date

2015-05-31

Last updated

2015-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Diabetic Macular Edema

Brief summary

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

Interventions

DRUGILUVIEN

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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

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

Participant flow

Participants by arm

Arm	Count
Laser laser with or without prior history of intraocular corticosteroid therapy ILUVIEN	6
Laser and Anti-VEGF laser and anti-VEGF therapy with or without prior history of intraocular corticosteroid therapy ILUVIEN	10
Total	16

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Lost to Follow-up	1	0

Baseline characteristics

Characteristic	Laser	Laser and Anti-VEGF	Total
Age, Continuous	66.65 years STANDARD_DEVIATION 9.014	60.87 years STANDARD_DEVIATION 11.006	63.04 years STANDARD_DEVIATION 10.398
Sex: Female, Male Female	2 Participants	5 Participants	7 Participants
Sex: Female, Male Male	4 Participants	5 Participants	9 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	— / —	— / —
other Total, other adverse events	2 / 6	3 / 10
serious Total, serious adverse events	0 / 6	2 / 10

Outcome results

Primary

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.