Bevacizumab for Neovascular Age-related Macular Degeneration

NCT ID: NCT01306591

Last Updated: 2011-03-02

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

NA

Total Enrollment

210 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2010-12-31

Brief Summary

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Age-related macular degeneration (AMD) is one of primary blinding eye disease among people over 65 years in China. The anti-VEGF antibody treatment is proved useful for Neovascular Age-related Macular Degeneration (nAMD) by many studies. Bevacizumab is the only available low-cost type of anti-VEGF drug currently in China. This study is a multi-center, randomized trial of Bevacizumab effective dose and safety for nAMD. This study is to explore the effective therapeutic approach that the majority of patients in China can bear establishing a suitable treatment for China.

Detailed Description

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Conditions

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Exudative Age-related Macular Degeneration

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Bevacizumab 1

Group Type ACTIVE_COMPARATOR

Bevacizumab 1

Intervention Type DRUG

Bevacizumab, 1.25mg/0.05ml, every 6 weeks, 42weeks

Bevacizumab 2

Group Type ACTIVE_COMPARATOR

Bevacizumab

Intervention Type DRUG

Bevacizumab, 1.25mg/0.05ml, 0week(baseline), 6week, 12week, 24week, 36week

Interventions

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Bevacizumab 1

Bevacizumab, 1.25mg/0.05ml, every 6 weeks, 42weeks

Intervention Type DRUG

Bevacizumab

Bevacizumab, 1.25mg/0.05ml, 0week(baseline), 6week, 12week, 24week, 36week

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Clinical diagnosis of neovascular Age-related macular degeneration
* Signed informed consent

Exclusion Criteria

* No other ocular fundus diseases
Minimum Eligible Age

50 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Peking University People's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Peking University People's Hospital

Principal Investigators

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Xiaoxin Li, doctor

Role: STUDY_CHAIR

Peking University People's Hospital

Locations

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Xiaoxin Li

Beijing, Beijing Municipality, China

Site Status

Countries

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China

References

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Li E, Donati S, Lindsley KB, Krzystolik MG, Virgili G. Treatment regimens for administration of anti-vascular endothelial growth factor agents for neovascular age-related macular degeneration. Cochrane Database Syst Rev. 2020 May 5;5(5):CD012208. doi: 10.1002/14651858.CD012208.pub2.

Reference Type DERIVED
PMID: 32374423 (View on PubMed)

Fang K, Tian J, Qing X, Li S, Hou J, Li J, Yu W, Chen D, Hu Y, Li X. Predictors of visual response to intravitreal bevacizumab for treatment of neovascular age-related macular degeneration. J Ophthalmol. 2013;2013:676049. doi: 10.1155/2013/676049. Epub 2013 Aug 28.

Reference Type DERIVED
PMID: 24069533 (View on PubMed)

Li X, Hu Y, Sun X, Zhang J, Zhang M; Neovascular Age-Related Macular Degeneration Treatment Trial Using Bevacizumab (NATTB). Bevacizumab for neovascular age-related macular degeneration in China. Ophthalmology. 2012 Oct;119(10):2087-93. doi: 10.1016/j.ophtha.2012.05.016. Epub 2012 Jul 20.

Reference Type DERIVED
PMID: 22818896 (View on PubMed)

Other Identifiers

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Bevacizumab for nAMD

Identifier Type: -

Identifier Source: org_study_id

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