E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Wet age-related macular degeneration |
Silmänpohjan kostea ikärappeuma |
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E.1.1.1 | Medical condition in easily understood language |
Wet age-related macular degeneration |
Silmänpohjan kostea ikärappeuma |
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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 |
Optimization of TER protocol |
TER -hoitomallin optimointi |
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Patients aged 50-85 years, BCVA 0.0625-0.8 Snellen |
Silmänpohjan kosteaa ikärappeumaa sairastavat potilaat, ikä 50-85 vuotta, paras lasikorjattu näöntarkkuus Snellen ekvivalentilla 0.0625-0.8
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E.4 | Principal exclusion criteria |
-no background diabetic/proliferative retinopathy -no previous arterial/venous occlusions of the eye -no previous retinal tears/detachments -no previous fundus laser coagulation -no previous retinal necrosis -no previous optic nerve inflammation -no previous vitreous haemorrhages -no previous vitreitis/endophthalmitis -no ocular/periocular infection -no glaucoma -no pathologic myopia -no eye surgeries in the previous six months -no hydrocephalus/intracranial pressure that increases intracranial expansion -no immunologic systemic disease -no use of other anti-neoplastic drugs -no pulmonary embolism, myocardial or cerebral infarction in the previous six months -no clinically significant cardiovascular disease (unstable angina pectoris, TIA) -no pregnancy or breast feeding -no renal failure -no hypothyroidism (or, if present, under therapeutic control) -no alcohol abuse -no previous gastrointestinal perforations -no hypersensitivity to an active agent (aflibercept)
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-ei diabeteksen aiheuttamaa tausta- / proliferatiivista retinopatiaa -ei aiempia silmän valtimo- / laskimotukoksia -ei aiempia verkkokalvon repeämiä / irtaumia -ei aiempaa silmänpohjan laserkoagulaatiota -ei aiempia verkkokalvon nekrooseja -ei aiempia näköhermon tulehduksia -ei aiempia lasiasverenvuotoja -ei aiempia vitriittejä / endoftalmiitteja -ei silmän / silmänympärysalueen infektiota -ei silmänpainetautia -ei patologista likitaitteisuutta -ei silmäleikkauksia edeltävän 6kk aikana -ei aivopainetta nostavia intrakranielliekspansioita / likvorkierron häiriötä -ei immunologisia systeemisairauksia -ei muiden antineoplastisten lääkkeiden käyttöä -ei viimeisen 6kk aikana sairastettua keuhkoemboliaa, sydän- tai aivoinfaktia -ei kliinisesti merkittävää kardiovaskulaarista sairautta (epästabiili angina pectoris, TIA) -ei raskautta tai imetystä -ei munuaisten vajaatoimintaa -ei kilpirauhasen vajaatoimintaa, joka ei ole hoitotasapainossa -ei alkoholin väärinkäyttöä -ei aiempia maha-suolikanavan perforaatioita -ei yliherkkyyttä vaikuttavalle aineelle (aflibersepti)
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E.5 End points |
E.5.1 | Primary end point(s) |
the mean change from the baseline best corrected visual acuity and the number of injections over the 24 months |
Näkökyky ETDRS-taululta ja lasiaisinjektioiden lukumäärä 24kk hoitomallilla |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
the length of time achieved in treatment intervals (treatment frequency), the number/frequency of relapses, changes retinal thickness. |
Saavutettu hoitoväli, relapsien lukumäärä ja tiheys, keskeisen verkkokalvon paksuus. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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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 |
Optimization of TER protocol |
TER -hoitomallin optimointi |
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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 | 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) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
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
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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 | 4 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |