Evaluation of Iluvien for the treatment of DME

Phase 1

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

• Registration Number: EUCTR2016-001680-37-ES
• Lead Sponsor: Dr. José Maria Ruiz Moreno

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-08-11
• Last Update Posted: 31 October 2016

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1.Patients =18 years of age, of either sex that have signed informed consent.
2.DME 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/or corticoesteroids injections 6 months ago or more, and meet the following:
-Mean central foveal thickness (central subfield thickness) = 290 µm in women and = 305 µm in men in Zeiss Cirrus OR = 305µm in women and = 320 µm in men in Heidelberg Spectralis, or equivalent accordingly with Tocon or Swep Source, 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 30
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

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 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 child-bearing potential women who do not want to use contraception methods during the study period.
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.
The patient is hypersensitive to the active agent or to one of the excipients.

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 efficacy of ILUVIEN in terms of change in best corrected visual acuity (BCVA) in patients with DME insufficiently responsive to prior available therapies with or without prior history of intraocular corticosteroid therapy.;Secondary Objective: 1.Changes in retinal thickness assessed using spectral domain optical coherence tomography (SD-OCT);<br>2.Occurrence of Adverse events (EA) <br>3. Quality of Life Analysis (VQF-25 questionnaire);Primary end point(s): BCVA after 2 years of implanting Iluvien;Timepoint(s) of evaluation of this end point: Screening visit and all follow up visits f the study: <br>After 7 days of implanting Iluvien <br>After 30 days<br>After 90 days <br>After 180 days <br>After 270 days <br>After 360 days <br>After 450 days <br>After 540 days<br>After 630 days <br>After 720 days (last study visit)

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Retinal thickness<br>Adverse Envents <br>Quality of Life;Timepoint(s) of evaluation of this end point: For Retinal thickness (OCT) and Adverse Events:<br>At the Screening visit and at all follow up visits f the study: <br>After 7 days of implanting Iluvien <br>After 30 days<br>After 90 days <br>After 180 days <br>After 270 days <br>After 360 days <br>After 450 days <br>After 540 days<br>After 630 days <br>After 720 days (last study visit)<br>For QoL at screening visit, and 180 days, 360 days and 720 days after implantation