|
|
|
|
| LEADER |
01000caa a22002652 4500 |
| 001 |
WHO007564953 |
| 003 |
DE-627 |
| 005 |
20230425171916.0 |
| 007 |
cr uuu---uuuuu |
| 008 |
210512s2021 xx |||||o 00| ||eng c |
| 035 |
|
|
|a (DE-627)WHO007564953
|
| 035 |
|
|
|a (UBBS_Klinische_Studien_WHO)EUCTR2019-004838-41-LV
|
| 035 |
|
|
|a (UBBS_Klinische_Studien_WHO)CSOK583A12301
|
| 035 |
|
|
|a (UBBS_Klinische_Studien_WHO)2019-004838-41-DE
|
| 040 |
|
|
|a DE-627
|b ger
|c DE-627
|e rakwb
|
| 041 |
|
|
|a eng
|
| 245 |
1 |
0 |
|a The study is investigating the use of an investigational medication (SOK583A1, a proposed biosimilar medicine to Eylea®) in wet AMD patients. The aim of study is to demonstrate similar safety and efficacy of the proposed biosimilar to the originator
|b A 52-week multicenter, randomized, double-masked, 2-arm parallel study to compare efficacy, safety and immunogenicity of SOK583A1 to Eylea®, administered intravitreally, in patients with neovascular age-related macular degeneration - MYLIGHT
|
| 264 |
|
1 |
|c 2021
|
| 336 |
|
|
|a Text
|b txt
|2 rdacontent
|
| 337 |
|
|
|a Computermedien
|b c
|2 rdamedia
|
| 338 |
|
|
|a Online-Ressource
|b cr
|2 rdacarrier
|
| 500 |
|
|
|a WHO International Clinical Trials Registry Platform (https://www.who.int/ictrp/en/), First posted: 26-10-2020, Last updated: 2022-11-24
|
| 650 |
|
4 |
|a Medical Condition: The ‘wet’ form of age-related macular degeneration (AMD) is a disease which affects the central part of the retina (called the macula) at the back of the eye. The wet form of AMD is caused by choroidal neovascularisation (the abnormal growth of blood vessels under the macula), which may leak fluid and blood and cause swelling (Eylea SmPC) MedDRA version: 20.0Level: LLTClassification code 10075568Term: Wet age-related macular degenerationSystem Organ Class: 100000004853;Therapeutic area: Diseases [C] - Eye Diseases [C11]
|
| 650 |
|
4 |
|a Study Type: Interventional
|
| 650 |
|
4 |
|a Phase: Phase 1
|
| 650 |
|
4 |
|a Recruitment Status: Authorised-recruitment may be ongoing or finished
|
| 650 |
|
4 |
|a 610
|
| 773 |
0 |
8 |
|i Enthalten in
|t WHO International Clinical Trials Registry Platform
|g (2021) vom: 15. Nov.
|
| 773 |
1 |
8 |
|g year:2021
|g day:15
|g month:11
|
| 856 |
4 |
0 |
|u https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2019-004838-41
|z kostenfrei
|3 Volltext
|
| 912 |
|
|
|a GBV_CTG
|
| 912 |
|
|
|a SSG-OLC-PHA
|
| 951 |
|
|
|a AR
|
| 952 |
|
|
|j 2021
|b 15
|c 11
|
Klinische Studie