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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)

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ClinicalTrials.gov Identifier: NCT00826371
Recruitment Status : Completed
First Posted : January 22, 2009
Last Update Posted : November 18, 2016
Sponsor:
Information provided by:
Novartis

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Age Related Macular Degeneration Drug: ranibizumab 0.5 mg Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 114 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : January 2009
Actual Primary Completion Date : July 2010


Arm Intervention/treatment
Experimental: 1 Drug: ranibizumab 0.5 mg



Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. To evaluate the effects of ranibizumab 0.5 mg on the change in BCVA from Baseline to Month 12. [ Time Frame: 12 Months ]
  2. 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 ]
  3. 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 ]


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Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00826371


Locations
China
Novartis Investigative Site
Beijing, China, 100044
Novartis Investigative Site
Beijing, China, 100730
Novartis Investigational Site
Chengdu, China, 610041
Novartis Investigative Site
Guangzhou, China, 510060
Novartis Investigative Site
Shanghai, China, 200031
Novartis Investigative Site
Shanghai, China, 200080
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals

Additional Information:
Publications of Results:
Responsible Party: External Affairs, Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00826371     History of Changes
Other Study ID Numbers: CRFB002A2203
First Posted: January 22, 2009    Key Record Dates
Last Update Posted: November 18, 2016
Last Verified: November 2016

Keywords provided by Novartis:
AMD
Ranibizumab

Additional relevant MeSH terms:
Macular Degeneration
Choroidal Neovascularization
Retinal Degeneration
Retinal Diseases
Eye Diseases
Choroid Diseases
Uveal Diseases
Neovascularization, Pathologic
Metaplasia
Pathologic Processes
Ranibizumab
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents