WHO ICTRP trial

A 24-month, phase IIIb, open-label, single arm, multicenter study assessing the…

NL-OMON37905 · Overview of Medical Research in the Netherlands (NL-OMON) · Not Recruiting

Key facts

Trial ID NL-OMON37905
Public title A 24-month, phase IIIb, open-label, single arm, multicenter study assessing the efficacy and safety of an individualized, stabilization criteria-driven pro re rata (PRN) dosing regimen with 0.5-mg ranibizumab intravitreal injections applied as monotherapy in patients with visual impairment due to macular edema secondary to central retinal vein occlusion (CRVO).
Scientific title A 24-month, phase IIIb, open-label, single arm, multicenter study assessing the efficacy and safety of an individualized, stabilization criteria-driven pro re rata (PRN) dosing regimen with 0.5-mg ranibizumab intravitreal injections applied as monotherapy in patients with visual impairment due to…
Primary sponsor Novartis
Registry Overview of Medical Research in the Netherlands (NL-OMON)
Recruitment status Not Recruiting
Study type Interventional
Phase 3
Countries Australia;Austria;Belgium;Canada;Czechia;Denmark;France;Greece;Hungary;Ireland;Italy;Netherlands ;Norway;Poland;Portugal;Slovakia;Spain;Sweden;Switzerland;Turkey;United Kingdom
Conditions visual impairment;10047060;visual impairment
Interventions The investigational treatment is 0.5 mg ranibizumab administered PRN by intravitreal injections. ;central retinal vein occlusion (CRVO);macular edema;visual impairment
Registration date Sep 19, 2012
Target size 25
Secondary IDs 2011-002350-31;NCT01535261;NL38012.058.11
Registry page onderzoekmetmensen.nl

At a glance

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Source: World Health Organization (WHO), International Clinical Trials Registry Platform (ICTRP) · Source date:

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