WHO ICTRP trial

Clinical study to compare efficacy and safety of Intas Ranibizumab with…

EUCTR2021-001970-41-LV · EU Clinical Trials Register · Authorised

Key facts

Trial ID EUCTR2021-001970-41-LV
Public title Clinical study to compare efficacy and safety of Intas Ranibizumab with Lucentis.
Scientific title A Double Masked, Parallel Group, Randomized, Multicenter, Clinical Study to Compare Efficacy and Safety of Intas Ranibizumab with Lucentis® in Patients with Neovascular (Wet) Age-Related Macular Degeneration (AMD). - CLARITY
Primary sponsor Intas Pharmaceuticals Ltd.
Registry EU Clinical Trials Register
Recruitment status Authorised
Study type Interventional clinical trial of medicinal product
Phase Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no
Countries Czechia;Hungary;Estonia;Poland;Ukraine;Russian Federation;Latvia;India
Conditions Neovascular (Wet) Age-Related Macular Degeneration (AMD) MedDRA version: 20.0 Level: PT Classification code 10071129 Term: Neovascular age-related macular degeneration System Organ Class: 10015919 - Eye disorders ;Therapeutic area: Diseases…
Interventions Trade Name: Lucentis Pharmaceutical Form: Solution for injection in vial INN or Proposed INN: RANIBIZUMAB CAS Number: 347396-82-1 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 10- Trade…
Registration date Feb 17, 2022
Target size 546
Secondary IDs 0504-19;2021-001970-41-HU
Registry page clinicaltrialsregister.eu

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