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Evaluation of Safety and Efficacy of Once Monthly Ranibizumab Injections in Chinese Patients With Wet Age Related Macular Degeneration (AMD) Patients (EXTEND II)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00826371
First Posted: January 22, 2009
Last Update Posted: November 18, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Novartis
January 16, 2009
January 22, 2009
November 18, 2016
January 2009
July 2010   (Final data collection date for primary outcome measure)
To evaluate efficacy of ranibizumab 0.5 mg by mean change in best-corrected visual acuity (BCVA) from Baseline to Month 4 as assessed with early treatment of diabetic retinopathy study (ETDRS) like charts at a distance of 4 meters. [ Time Frame: 12 months ]
Same as current
Complete list of historical versions of study NCT00826371 on ClinicalTrials.gov Archive Site
  • To evaluate the effects of ranibizumab 0.5 mg on the change in BCVA from Baseline to Month 12. [ Time Frame: 12 Months ]
  • To evaluate effects of ranibizumab 0.5 mg on retinal structure at Month 4 and Month 12 as assessed by fundus photography, fluorescein angiography, and optical coherence tomography. [ Time Frame: 12 Months ]
  • To evaluate safety of ranibizumab 0.5 mg by rates of adverse events/SAEs, ophthalmic exams, tonometry, and changes in laboratory values/vital signs at Months 4 and 12. [ Time Frame: 12 Months ]
Same as current
Not Provided
Not Provided
 
Evaluation of Safety and Efficacy of Once Monthly Ranibizumab Injections in Chinese Patients With Wet Age Related Macular Degeneration (AMD) Patients
An Open-label, Multicenter Study to Evaluate the Efficacy and Safety of Ranibizumab (0.5 mg) in Patients With Subfoveal Choroidal Neovascularization Secondary to Age-related Macular Degeneration Over 12 Months
The purpose of the study is to provide efficacy and safety data for monthly ranibizumab 0.5 mg intravitreal injections in Chinese patients with subfoveal choroidal neovascularization (CNV) secondary to age-related macular degeneration (AMD). The study results will support the regulatory submission in China to make ranibizumab available for clinical use.
Not Provided
Interventional
Phase 3
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Age Related Macular Degeneration
Drug: ranibizumab 0.5 mg
Experimental: 1
Intervention: Drug: ranibizumab 0.5 mg
Zhao J, Li X, Tang S, Xu G, Xu X, Zhang F, Zhang M, Shamsazar J, Pilz S, Nieweg A. EXTEND II: an open-label phase III multicentre study to evaluate efficacy and safety of ranibizumab in Chinese patients with subfoveal choroidal neovascularization secondary to age-related macular degeneration. BioDrugs. 2014 Dec;28(6):527-36. doi: 10.1007/s40259-014-0106-1.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
114
Not Provided
July 2010   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Male or female Chinese patients 50 years of age or greater.
  • Patients with primary or recurrent subfoveal CNV secondary to AMD.
  • Patients who have a BCVA score from 73 to 24 characters in the study eye.

Exclusion Criteria:

  • Active, or history of, ocular inflammation or infection in the study eye within the last 30 days.
  • Uncontrolled glaucoma in the study eye.

Other protocol-defined inclusion/exclusion criteria may apply.

Sexes Eligible for Study: All
50 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
China
 
 
NCT00826371
CRFB002A2203
Not Provided
Not Provided
Not Provided
External Affairs, Novartis Pharmaceuticals
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
November 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP