E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
patients with newly diagnosed, unilateral, wet Are-Related Macular Degeneration |
Újonnan diagnosztizált egyoldali nedves típusú makula degeneráció |
|
E.1.1.1 | Medical condition in easily understood language |
Wet Macular Degeneration |
Nedves típusú makula degeneráció |
|
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 | 17.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10067791 |
E.1.2 | Term | Wet macular degeneration |
E.1.2 | System Organ Class | 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 |
The primary objective of the current study is to investigate the effect of BI 144807 treatment on central 1-mm retinal thickness in wAMD patients as assessed by SD-OCT |
Elsődleges célja a jelen vizsgálatnak a BI 144807 kezelés hatásának értékelése az 1mm-es centrális retinavastagságra SD-OCT-vel mérve wAMD-ben |
|
E.2.2 | Secondary objectives of the trial |
A secondary outcome will be to assess the effect of BI 144807 on neovascular leakage as assessed by fluorescin angiography |
Másodlagosan a BI 144807 hatásának értékelés a neovaszkuláris szivárgásra fluoreszcein angiográfiával |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Newly diagnosed men and women with unilateral subfoveal choroideal neovascularization secondary to age-related macular degeneration |
Férfi vagy nő beteg újonnan diagnosztizált egyoldali subfoveális CNV talaján kialakult időskori makula degenerációval |
|
E.4 | Principal exclusion criteria |
Additional eye disease that could compromizse best corrected visual acuity, such as uncontrolled glaucoma |
Egyéb szembetegség, mely a legjobban javított látóélességet veszélyeztetheti, mintp például a kezeletlen galukóma |
|
E.5 End points |
E.5.1 | Primary end point(s) |
1: Change from baseline in 1mm central retinal thickness as measured by SD-OCT
|
Az 1mm -es centrális retinavastagság változása a kiinduláshoz képest SD-OCT-vel mérve |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
1: Baseline and 4 weeks
|
Kiindulás és a 4. hét |
|
E.5.2 | Secondary end point(s) |
1: Change in neovascular leakage by fluorescein angiography from baseline
|
A neovaszkuláris szivárgás változása a kiinduláshoz képest fluoreszcein angiográfiával |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
1: Baseline and 4 weeks
|
Kiindulás és a 4. hét |
|
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 | No |
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 | Information not present in EudraCT |
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 | No |
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 | No |
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
| 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 | 4 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 12 |
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 |
Utolsó beteg utolsó vizitje |
|
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 | 9 |
E.8.9.1 | In the Member State concerned days | 26 |
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 | 9 |
E.8.9.2 | In all countries concerned by the trial days | 26 |