E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Retinal function in patients with wet age-related macular degeneration |
|
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10067791 |
E.1.2 | Term | Wet macular degeneration |
E.1.2 | System Organ Class | 10015919 - Eye disorders |
|
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 |
Main outcome measures are the changes of retinal function of the macula monitored by multifocal-ERG as measured 12 months. |
|
E.2.2 | Secondary objectives of the trial |
• to document changes in best corrected visual acuity (BCVA) measured on 4 meters, • to document changes in microperimetry (absolute scotoma size and fixation) • to document changes in optical coherence tomography (OCT)
|
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Diabetic macular edema with center involvement in at least one eye • Patients with a central retinal thickness (CRT) > 250 µm • Patients with a BCVA of 78-24 EDTRS letters • Decrease in vision is due to DME and not due to other causes, in the opinion of the investigator • Type 1 or type 2 diabetes mellitus diagnosed 2 years prior to screening
|
|
E.4 | Principal exclusion criteria |
1. history or evidence of severe cardiac disease (e.g., NYHA functional class III or IV) 2. clinical or medical history uncontrolled hypertension or diabetes 3. of unstable angina, acute coronary syndrome, myocardial infarction or revascularization with 6 months 4. ventricular tachyarrythmias requiring ongoing treatment 5. History or evidence clinically significant peripheral vascular disease, such as intermittent claudication or prior amputation 6. Clinically significant impaired renal or hepatic function 7. Stroke within 12 month before trial entry. 8. Pregnancy 9. Known serious allergies to the fluorescein dye use in angiography 10. Known contraindications to the components of Lucentis® formulation.Current use of or likely need for systemic medications known to be toxic to the lens, retina or optic nerve, including Deferoxamine, Chloroquine/ hydroxychloroquine (Plaquenil), Tamoxifen, Phenothiazines and Ethambutol 11. Known hypersensitivity to ranibizumab or any component of the ranibizumab formulation
|
|
E.5 End points |
E.5.1 | Primary end point(s) |
Main outcome measures are the changes of retinal function of the macula monitored by multifocal-ERG as measured 12 months. |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Yes |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Information not present in EudraCT |
E.6.5 | Efficacy | Information not present in EudraCT |
E.6.6 | Pharmacokinetic | Information not present in EudraCT |
E.6.7 | Pharmacodynamic | Information not present in EudraCT |
E.6.8 | Bioequivalence | Information not present in EudraCT |
E.6.9 | Dose response | Information not present in EudraCT |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | Information not present in EudraCT |
E.6.12 | Pharmacoeconomic | Information not present in EudraCT |
E.6.13 | Others | Information not present in EudraCT |
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 | 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.8.3 |
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
|
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |