E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Diabetic macular edema |
Diabetisches Makulaödem |
|
E.1.1.1 | Medical condition in easily understood language |
Diabetic macular edema |
Diabetisches Makulaödem |
|
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 | 17.1 |
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 |
|
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 influence of an intensified diabetes control program on treatment of diabetic macular edema. |
Bestimmung des Einflusses eines intensivierten Diabetes-Kontrollprogramms auf die Behandlung eines diabetischen Makulaödems mit Ranibizumab. |
|
E.2.2 | Secondary objectives of the trial |
To evaluate:
-the number of treatments with ranibizumab
-the mean average change in BCVA
-the macular thickness (as measured with OCT)
-the time needed to reach the target HbA1c
-the number of neovascular complications with need of PRP
-the safety of the treatment of DME with ranibizumab based on ocular and systemic adverse events |
Bestimmung der:
-Anzahl der Behandlungen mit Ranibizumab
-durchschnittlichen Veränderung der BCVA
-Makuladicke (gemessen mit OCT)
-Zeit bis zum Erreichen des HbA1c-Zielwertes
-Anzahl neovaskulärer Komplikationen: Notwendigkeit einer PRP
-Anzahl okularer und systemischer Adverse Events (Netzhautablösung, Verschluss der zentralen Netzhautarterie, Endophthalmitis; Anzahl von Schlaganfällen, Myokardinfarkten, schweren Hypoglykämien) |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
-Patients with diabetic macular edema relevant to visual acuity
-OCT retinal thickness >= 250µm
-HbA1c > 6,5% at initial visit
-BCVA <= 0.8 and >= 0,05
-Age >= 18 years
-Written informed consent given |
-Patienten mit DMÖ, welches Einfluss auf die Sehschärfe hat
-Netzhautdicke >= 250µm (OCT)
-HbA1c > 6,5% bei Einschluss
-BCVA- Wert <= 0,8 und >= 0,05
-Alter >= 18 Jahre
-Schriftliche Einwilligung liegt vor
|
|
E.4 | Principal exclusion criteria |
-Previous treatment with intravitreal drugs in last 6 months
-Vitreous hemorrhage as a consequence of proliferative retinopathy which would hamper adequate diagnosis and imaging
-Blood pressure of >= 180/100 (or uncontrolled pressures under pharmacological therapy)
-Chronic systemic or ocular inflammatory/autoimmune diseases (e.g. inflammatory bowel disease, Addison´s disease, Cushing Syndrome, Uveitis)
-Systemic cortisone or anti-VEGF therapy
-Acute systemic or ocular infectious diseases
-Prior laser photocoagulation treatment within 3 months (focal / grid laser or panretinal) prior to study entry
-Current treatment with pharmaceutical preparations with which interactions can be expected
-Persons who have a fluorescein allergy
-Women who are pregnant or breast feeding |
-Behandlung mit intravitrealen Medikamenten in den letzten 6 Monaten
-Einblutung in den Glaskörper als Folge einer proliferativen Retinopathie, die eine adäquate Diagnose und Bildgebung verhindern würde
-Blutdruck >= 180/100 (oder unkontrollierter Blutdruck unter medikamentöser Therapie)
-Chronisch systemische oder okuläre inflammatorische/autoimmune Erkrankungen (z.B. chronisch-entzündliche Darmerkrankung, Morbus Addison, Cushing-Syndrom, Uveitis)
-Systemische Kortison- oder anti-VEGF-Therapie
-Akute systemische oder okulare Infektionserkrankungen
-Laserphotokoagulationsbehandlung (focal/grid oder panretinal) innerhalb von drei Monaten vor Studieneintritt
-Laufende Behandlung mir Präparaten, für die Wechselwirkungen erwartet werden können
-Personen mit Fluoreszein-Allergie
-Schwangere oder stillende Frauen |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Change of best corrected visual acuity (BCVA) in ETDRS letters score at month 12 when compared with baseline. |
Veränderung der bestmöglichen Sehschärfe (BCVA) mittels ETDRS Tafel nach 12 Monaten im Vergleich zur Baseline. |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
|
E.5.2 | Secondary end point(s) |
-Number of treatments with ranibizumab up to 6, 18 and 24 months of treatment respectively
-Mean average change in BCVA at 6 , 12 , 18 and 24 months after initial treatment
-Macular thickness (as measured with OCT) at 6 , 12 , 18 and 24 months after initial treatment
-Time to reach target HbA1c
-Number of neovascular complications: need for PRP
-Rates of ocular and systemic adverse events (retinal detachment, central retinal artery occlusion, endophthalmitis; rates of stroke, myocardial infarction, severe hypoglycemia) |
-Anzahl der Behandlungen mit Ranibizumab von Baseline bis Monat 6, 12, 18, 24
-Durchschnittliche Veränderung der BCVA nach 6, 12, 18 und 24 Monaten nach Initialbehandlung
-Makuladicke (gemessen mit OCT) nach 6, 12, 18 und 24 Monaten nach Initialbehandlung
-Zeit bis zum Erreichen des HbA1c-Zielwertes
-Anzahl neovaskulärer Komplikationen: Notwendigkeit einer PRP
-Anzahl okularer und systemischer Adverse Events (Netzhautablösung, Verschluss der zentralen Netzhautarterie, Endophthalmitis; Anzahl von Schlaganfällen, Myokardinfarkten, schweren Hypoglykämien) |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
1.-3. months 6, 12, 18 and 24
4.-6. EoS |
1.-3. Monat 6, 12, 18 und 24
4.-6. Studienende |
|
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 | 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) | 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 | Yes |
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 | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
Personen, die BCVA, Makuladicke & Kapillardurchblutung messen, sind verblindet |
Observer-masking |
|
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 | Yes |
E.8.2.3.1 | Comparator description |
Reguläre glykämische Kontrolle der Diabetes |
Regular glycemic control of the diabetic disease |
|
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.8.5 | 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
|
LVLS |
Letzte Visite des letzten Patienten (LPLV) |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |