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Bevacizumab for Neovascular Age-related Macular Degeneration

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. Identifier: NCT01306591
Recruitment Status : Completed
First Posted : March 2, 2011
Last Update Posted : March 2, 2011
Information provided by:
Peking University People's Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Exudative Age-related Macular Degeneration Drug: Bevacizumab 1 Drug: Bevacizumab Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 210 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Randomized Multi-center Clinical Study:Bevacizumab for Neovascular Age-related Macular Degeneration
Study Start Date : January 2008
Actual Primary Completion Date : June 2010
Actual Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

Drug Information available for: Bevacizumab

Arm Intervention/treatment
Active Comparator: Bevacizumab 1 Drug: Bevacizumab 1
Bevacizumab, 1.25mg/0.05ml, every 6 weeks, 42weeks

Active Comparator: Bevacizumab 2 Drug: Bevacizumab
Bevacizumab, 1.25mg/0.05ml, 0week(baseline), 6week, 12week, 24week, 36week

Primary Outcome Measures :
  1. EDTRS visual acuity score [ Time Frame: 0week(baseline), 6week, 12week, 18week, 24week, 30week, 36week, 42week, 48week ]
    EDTRS visual acuity score is assessed at each timepoint for every group

Secondary Outcome Measures :
  1. macular thickness in OCT [ Time Frame: 0week(baseline), 6week, 12week, 18week, 24week, 30week, 36week, 42week, 48week ]
    macular thickness is assessed at each timepoint for every group

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   50 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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

Exclusion Criteria:

  • No other ocular fundus diseases

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 identifier (NCT number): NCT01306591

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China, Beijing
Xiaoxin Li
Beijing, Beijing, China, 100044
Sponsors and Collaborators
Peking University People's Hospital
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Study Chair: Xiaoxin Li, doctor Peking University People's Hospital
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Peking University People's Hospital Identifier: NCT01306591    
Other Study ID Numbers: Bevacizumab for nAMD
First Posted: March 2, 2011    Key Record Dates
Last Update Posted: March 2, 2011
Last Verified: December 2010
Keywords provided by Peking University People's Hospital:
neovascular age-related macular degeneration
Multicenter Randomized Study
Additional relevant MeSH terms:
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Macular Degeneration
Wet Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Antineoplastic Agents, Immunological
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors