E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
DIABETIC MACULAR EDEMA (DME) |
Edema maculare diabetico (EMD) |
|
E.1.1.1 | Medical condition in easily understood language |
DIABETIC MACULAR EDEMA (DME) |
Edema maculare diabetico (EMD) |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Eye Diseases [C11] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10057934 |
E.1.2 | Term | Diabetic macular edema |
E.1.2 | System Organ Class | 100000004853 |
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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 evaluate the effect of IFN on DME, by measuring central foveal thickness (CFT). |
Valutare l’effetto dell’IFN-α sull’EMD, attraverso la misurazione dello spessore retinico della regione foveale con OCT |
|
E.2.2 | Secondary objectives of the trial |
To evaluate the effect of IFN on visual acuity (VA).
To evaluate the maximum time lenght of the effect of IFN, during which further treatment are not necessary.
To evaluate the safety and tolerability of subtenon IFN |
1) Valutare l’effetto dell’IFN-α sull’AV
2) Valutare il tempo massimo di effetto della terapia sperimentale somministrata, durante il quale non è richiesto un ulteriore trattamento dell’EMD.
3) Valutare la sicurezza e la tollerabilità del trattamento con IFN-α. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Patients affected by diabetes mellitus type II
• DME documented by OCT examination (diffuse macular edema, cystoid macular edema, retinal serous detachment) with central foveal thickness > 300µm
• Best corrected visual acuity from 2/10 to 6/10
• Age > 18 years old
• Glycated hemoglobin < 8% and glycemia < 220 mg/dl
• Signed written informed consent
• If both eyes of the patient meet the inclusion criteria, the worse eye will be selected for the treatment with IFN. |
Pazienti affetti da diabete mellito tipo II
EMD confermato da OCT (edema retinico diffuso, edema cistoide, distacco sieroso retinico) con spessore retinico > 300µm
AV corretta compresa tra 2/10 e 6/10
Età superiore ai 18 anni
Emoglobina glicata < 8% e glicemia < 220 mg/dl
Firma del consenso informato
Se entrambi gli occhi del paziente rientrano nei criteri di inclusione, verrà trattato con il farmaco in studio l’occhio peggiore |
|
E.4 | Principal exclusion criteria |
• Macular laser treatments in the previous 12 months.
• Anti-VEGF or steroid intravitreal treatment in the previous 3 months.
• Tractional diabetic macular edema
• Proliferative diabetic retinopathy and/or vitreous hemorrhage.
• Cataract surgery in the previous 6 months.
• Any other ocular surgery in the previous 2 years.
• Any other concomitant ocular disease, except for diabetic retinopathy.
• Systemic steroid therapy
• Systemic or topic interferon therapy
• Pregnant or breastfeeding women
• Known or suspected hypersensitivity to the experimental drug or to other drugs belonging to the pharmacologic class of the INF.
• Severe clinical conditions that, in the opinion of the investigator, could preclude the patient’s enrollment to the study.
• Any other experimental systemic drugs in the previous 6 months. |
• Trattamenti laser retinici focali maculari nei 12 mesi precedenti
• Trattamenti intravitreali con farmaci antiangiogenetici o corticosteroidei nei 3 mesi precedenti
• Edema maculare diabetico di tipo trazionale
• Retinopatia diabetica proliferante ed emorragia vitreale
• Chirurgia della cataratta nei 6 mesi precedenti
• Altri interventi di chirurgia oculare nei 2 anni precedenti
• Altre patologie oculari concomitanti
• Pazienti in terapia corticosteroidea per via sistemica
• Pazienti in terapia con interferone per via topica o sistemica
• Donne in gravidanza e donne in allattamento
• Nota o sospetta ipersensibilità al farmaco o alla classe farmacologica in studio
• Pazienti con gravi condizioni cliniche che, a giudizio dello sperimentatore, controindicano la partecipazione del paziente allo studio
• Utilizzo di farmaci sperimentali per uso sistemico negli ultimi 6 mesi prima dell’inclusione nello studio |
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E.5 End points |
E.5.1 | Primary end point(s) |
To evaluate the effect of IFN on DME, by measuring central foveal thickness (CFT). |
Valutare l’effetto dell’INF-α sull’EMD, attraverso la misurazione dello spessore retinico della regione foveale con OCT |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
|
E.5.2 | Secondary end point(s) |
To evaluate the effect of IFN on visual acuity (VA).
To evaluate the maximum time lenght of the effect of IFN, during which further treatment are not necessary.
To evaluate the safety and tolerability of subtenon IFN |
1) Valutare l’effetto dell’IFN-α sull’AV
2) Valutare il tempo massimo di effetto della terapia sperimentale somministrata, durante il quale non è richiesto un ulteriore trattamento dell’EMD.
3) Valutare la sicurezza e la tollerabilità del trattamento con IFN-α. |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
|
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 | No |
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 | No |
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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | Information not present in EudraCT |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
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
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
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
|
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 24 |
E.8.9.1 | In the Member State concerned days | 0 |