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

NCT ID: NCT00826371

Last Updated: 2016-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

114 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Brief Summary

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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

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Conditions

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Age Related Macular Degeneration

Keywords

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AMD Ranibizumab

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Group Type EXPERIMENTAL

ranibizumab 0.5 mg

Intervention Type DRUG

Interventions

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ranibizumab 0.5 mg

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Novartis Pharmaceuticals

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Novartis Investigative Site

Beijing, , China

Site Status

Novartis Investigative Site

Beijing, , China

Site Status

Novartis Investigational Site

Chengdu, , China

Site Status

Novartis Investigative Site

Guangzhou, , China

Site Status

Novartis Investigative Site

Shanghai, , China

Site Status

Novartis Investigative Site

Shanghai, , China

Site Status

Countries

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China

References

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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.

Reference Type RESULT
PMID: 25012926 (View on PubMed)

Other Identifiers

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CRFB002A2203

Identifier Type: -

Identifier Source: org_study_id