A Pilot Study on the Effect and Safety of Iluvien® in Chronic Diabetic Macular Edema Patients

Study Overview
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Brief Summary
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To provide treating physicians with experience with ILUVIEN as well as monitoring its safety (and effectiveness) in a real-life chronic diabetic macular edema (DME) patients judged insufficiently responsive to available therapies.

Official Title
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A Non-randomised, Open-label, Multicenter Phase 4 Pilot Study on the Effect and Safety of Iluvien® in Chronic Diabetic Macular Edema Patients Considered Insufficiently Responsive to Available Therapies With or Without Intravitreal Corticosteroid Therapy (RESPOND)

Conditions
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Diabetic Macular Edema

Intervention / Treatment
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* Drug: IlUVIEN


Participation Criteria
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Eligibility Criteria
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Chronic DME patients considered insufficiently responsive to available therapies (laser, anti-VEGF) with or without intravitreal corticosteroid therapy. Inclusion Criteria: Adults (≥18 years) with chronic DME; Patients considered as insufficiently responsive as defined as having underwent other previous treatments, including at least 3 anti-VEGF injections in the last 6 months, and the following: Mean central foveal thickness (central subfield thickness) ≥ 290 um in women and ≥ 305 um in men in Zeiss Cirrus OR ≥ 305 um in women and ≥ 320 um in men in Heidelberg Spectralis, in the study eye as measured using SD-OCT; Vision impairment (20/50 to 20/400 using Snellen visual acuity equivalent) related to DME; If in the Investigator's opinion a further improvement is possible. Exclusion Criteria: IOP > 21 mmHg at screening (day -14) in the study eye. Historical rise in IOP > 25 mmHg following treatment with an intravitreal corticosteroid in the study eye. Use of ≥ 2 active agents as IOP-lowering medications to control IOP at screening in the study eye. Vitreomacular traction in DME and opaque media in the study eye. Severe proliferative diabetic retinopathy requiring pan retinal photocoagulation in the study eye. Pregnant or breastfeeding women. Active angiographic central macular ischaemia before baseline in the study eye. Pan retinal photocoagulation or cataract surgery 3 months before baseline in the study eye. Presence of pre-existing glaucoma, active or suspected ocular or periocular infection and/or hypersensitive to the active agent or to one of the excipients. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant UNLESS they are: using a highly effective method of birth control.

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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ILUVIEN 190 ug intravitreal implant<br>All patients will receive ILUVIEN 190 micrograms intravitreal implant in applicator with an initial release rate of 0.2 microgram per day. The implant will be administered by injection according to the method of administration defined in the SmPC (ILUVIEN SmPC). Only one eye of each patient will be treated with ILUVIEN. | Drug: IlUVIEN<br>* All patients will receive ILUVIEN 190 micrograms intravitreal implant in applicator with an initial release rate of 0.2 microgram per day. The implant will be administered by injection according to the method of administration defined in the SmPC (ILUVIEN SmPC). Only one eye of each patient will be treated with ILUVIEN.<br>* Other names: Fluocinolone Acetonide;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in best-corrected visual acuity (BCVA) from baseline to Month-12 |  | Baseline to 12 months | 
| Changes in central retinal thickness assessed using spectral domain optical coherence tomography (SD-OCT) from baseline to Month-12 |  | Baseline to 12 months | 
| Occurrence of Adverse events, namely cataract and elevated IOP |  | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic Diabetic Macular Edema, Iluvien, Intra-vitreal injections, Pilot study