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

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

January 16, 2009

Last Updated Date

February 10, 2009

Start Date ^†

February 2009

Current Primary Outcome Measures ^†

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 ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00826371 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

To evaluate the effects of ranibizumab 0.5 mg on the change in BCVA from Baseline to Month 12. [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^†

Same as current

Descriptive Information

Brief Title ^†

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

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

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.

Detailed Description

Study Phase

Phase III

Study Type ^†

Interventional

Study Design ^†

Treatment, Open Label, Single Group Assignment

Condition ^†

Age Related Macular Degeneration

Intervention ^†

Drug: ranibizumab 0.5 mg

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Recruiting

Estimated Enrollment ^†

110

Completion Date

Estimated Primary Completion Date

February 2011 (final data collection date for primary outcome measure)

Eligibility 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.

Gender

Both

Ages

50 Years and older

Accepts Healthy Volunteers

Contacts ^††

Contact: Novartis Pharmaceuticals

+41-61-324-1111

Location Countries ^†

China

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00826371

Responsible Party

External Affairs, Novartis Pharmaceuticals

Secondary IDs ^††

Study Sponsor ^†

Novartis Pharmaceuticals

Collaborators ^††

Investigators ^†

Study Director:

Novartis Pharmaceuticals

Information Provided By

Novartis

Verification Date

February 2009

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.