E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Diabetic Macular Edema |
Edema Macular Diabético |
|
E.1.1.1 | Medical condition in easily understood language |
Diabetic Macular Edema |
Edema Macular Diabético |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Eye Diseases [C11] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
Evaluar la eficácia de ILUVIEN en términos de Cambios en la Mejor Agudeza Visual Corregida (MAVC) en pacientes con EMD con respuesta insuficiente a terapias disponibles |
|
E.2.2 | Secondary objectives of the trial |
1. Changes in retinal thickness assessed using spectral domain optical coherence tomography (SD-OCT); 2. Occurrence of Adverse events (EA) 3. Quality of Life Analysis (VQF-25 questionnaire) |
1. Cambios en el espesor retiniano evaluada por tomografía de coherencia óptica de dominio espectral (SD-OCT) o Swept-Source OCT (SS-OCT). 2. Presencia de acontecimientos adversos (AA) 3. Análisis Calidad de Vida (cuestionario VQF-25) |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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. |
1. Pacientes ≥ 18 años de edad, de ambos sexos que hayan firmado el consentimiento informado. 2. EMD basado en la evaluación clínica del investigador y demostrada por fotografía del fondo de ojo y SD-OCT o SS-OCT 3. Pacientes con respuesta a las terapia disponibles considerada insuficiente, que hayan recibido, al menos, 3 inyecciones anti-VEGF en los últimos 6 meses y/o hayan recibido inyección de esteroides intravítreos hace 6 meses o más y además, cumpla los siguientes criterios: - Espesor foveal central medio (grosor del subcampo central) ≥ 290 µm en mujeres y ≥ 305 µm en hombres en Zeiss Cirrus ó ≥ 305 µm en mujeres y ≥ 320 µm en hombres en Heidelberg Spectralis, o equivalente según Tocon ó Swept Source en el ojo de estudio, utilizando SD-OCT o SS-OCT; - Deterioro visual relacionado com el EMD (20/50 a 20/400 utilizando escala Snellen); - Si, en opinión del investigador, es posible una mejora adicional. |
|
E.4 | Principal 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. |
1. PIO > 21 mm Hg en la visita de screening, en el ojo de estudio. 2. Antecedentes de aumento de PIO > 25 mmHg posterior al tratamiento con costicosteroides intravítreos en el ojo de estudio. 3. Uso de ≥ 2 agentes activos como medicamentos para reducir y controlar la PIO en el día de selección en el ojo de estudio. 4. Pacientes con EMD con tracción vítreomacular y medios opacos en el ojo de estudio. 5. Pacientes con retinopatía diabética proliferativa severa que requieran fotocoagulación panretiniana en el ojo de estudio. 6. Mujeres embarazadas o mujeres en edad fértil que no deseen utilizar métodos anticonceptivos a lo largo de todo el estudio. 7. Pacientes diagnosticados por angiografía, de isquémia macular central previa a la selección en el ojo de estudio. 8. Pacientes que hayan recibido panfotocoagulación o cirugía de cataratas en los 3 meses previos a la visita de selección en el ojo de estudio. 9. Pacientes con inyección de esteroides intravítreos, subtenoniana o periocular en los seis meses anteriores a la selección en el estudio (ejemplo: ILUVIEN®, Ozurdex® o triamcinolona) 10. Pacientes con contraindicaciones: a. Diagnóstico de glaucoma pre-existente. b. Infección activa o sospecha de infección ocular y periocular. c. Paciente hipersensible al agente activo o a alguno de los excipientes |
|
E.5 End points |
E.5.1 | Primary end point(s) |
BCVA after 2 years of implanting Iluvien |
MAVC a los dos años desde el implante de Iluvien |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
Screening visit and all follow up visits f the study: After 7 days of implanting Iluvien After 30 days After 90 days After 180 days After 270 days After 360 days After 450 days After 540 days After 630 days After 720 days (last study visit) |
En la visita de screening y en todas las visita de estudio tras el implante de Iluvien: A los 7 días A los 30 días A los 90 días A los 180 días A los 270 días A los 360 días A los 450 días A los 540 días A los 630 días A los 720 días (última visita de estudio) |
|
E.5.2 | Secondary end point(s) |
Retinal thickness Adverse Envents Quality of Life |
Espesor retiniano Acontecimientos Adversos Calidad de Vida |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
For Retinal thickness (OCT) and Adverse Events: At the Screening visit and at all follow up visits f the study: After 7 days of implanting Iluvien After 30 days After 90 days After 180 days After 270 days After 360 days After 450 days After 540 days After 630 days After 720 days (last study visit) For QoL at screening visit, and 180 days, 360 days and 720 days after implantation |
Para Espesor Retiniano (OCT) y Acontecimientos Adversos: En la visita de screening y en todas las visita de estudio tras el implante de Iluvien: A los 7 días A los 30 días A los 90 días A los 180 días A los 270 días A los 360 días A los 450 días A los 540 días A los 630 días A los 720 días (última visita de estudio) Para Calidad de Vida (VQF-25) en la visita de screening y a los 180 días, 360 días y 720 días tras el implante de Iluvien |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
Quality of Life |
Calidad de Vida |
|
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
|
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 1 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 8 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |