WHO ICTRP trial

An open-label, multi-center, 24-month extension study to evaluate the safety of…

EUCTR2008-007467-17-FR · EU Clinical Trials Register · Not Recruiting

Key facts

Trial ID EUCTR2008-007467-17-FR
Public title An open-label, multi-center, 24-month extension study to evaluate the safety of ranibizumab as symptomatic treatment for visual impairment due to diabetic macular edema in patients who have completed the RESTORE trial - RESTORE EXTENSION
Scientific title An open-label, multi-center, 24-month extension study to evaluate the safety of ranibizumab as symptomatic treatment for visual impairment due to diabetic macular edema in patients who have completed the RESTORE trial - RESTORE EXTENSION
Primary sponsor Novartis Pharma Services AG
Registry EU Clinical Trials Register
Recruitment status Not Recruiting
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 France;Hungary;Belgium;Spain;Germany;Netherlands;Italy;United Kingdom
Conditions Diabetic Macular Edema (DME) MedDRA version: 9.1 Level: LLT Classification code 10057934 Term: Diabetic macular edema
Interventions Trade Name: Lucentis Product Name: Lucentis Product Code: RFB002D Pharmaceutical Form: Solution for injection INN or Proposed INN: Ranibizumab Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number…
Registration date Jan 4, 2009
Target size 320
Secondary IDs RFB002D2301E1
Registry page clinicaltrialsregister.eu

At a glance

  • Yes Results available

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

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