This is a non-randomised, open-label which means that patients know they will receive the active medicine. No placebo will be used. The study will examine the effect and safety of Iluvien® in chronic diabetic macular edema patients. Patients would have been treated previously with other available therapies such as laser photo coagulation or a therapy called anti-VEGF or with corticosteroid therapy.

Phase 1

• Conditions: Chronic Diabetic Medical Edema; Therapeutic area: Diseases [C] - Eye Diseases [C11]

• Registration Number: EUCTR2014-003491-23-PT
• Lead Sponsor: AIBILI – Association for Innovation and Biomedical Research on Light and Image

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-10-14
• Last Update Posted: 18 April 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Patients =18 years of age, of either sex that have signed informed consent.
2. Chronic DME, defined as a history of macular edema with duration > 1 year having already received other therapy, based on investigator’s clinical evaluation and demonstrated using fundoscopic photography and SD-OCT.
3. 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) = 290um in women and = 305um in men in Zeiss Cirrus OR = 305um in women and = 320um 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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 8
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 4

Exclusion Criteria

1. IOP > 21 mmHg at screening (day -14) 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 active agents as 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 women.
7. Patients diagnosed with active angiographic central macular 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 screening visit in the study eye.
9. Patients with contraindications:
a. Presence of pre-existing glaucoma.
b. Active or suspected ocular or periocular infection.
c. The patient is hypersensitive to the active agent or to one of the excipients.
10. 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 (i.e. one that results in a less than 1% per year failure rate when used consistently and correctly, such as implants, injectables, combined oral contraceptives, and some intrauterine devices – IUDs). Periodic abstinence (e.g. calendar, ovulation, symptothermal, post-ovulation methods) are not acceptable. Reliable contraception should be maintained throughout the study and for 30 days after study drug discontinuation.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess the effect and safety of ILUVIEN in patients with chronic DME insufficiently responsive to prior available therapies with or without prior history of intraocular corticosteroid therapy.;Secondary Objective: Not applicable;Primary end point(s): - Changes in best-corrected visual acuity (BCVA) from baseline to Month-12;<br>- Changes in central retinal thickness assessed using spectral domain optical coherence tomography (SD-OCT) from baseline to Month-12;<br>- Occurrence of Adverse events, namely cataract and elevated IOP<br>;Timepoint(s) of evaluation of this end point: Evaluation done at Months 1, 3, 6, 9 and 12.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not applicable