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Bevacizumab for Neovascular Age-related Macular Degeneration

This study has been completed.
Information provided by:
Peking University People's Hospital Identifier:
First received: March 1, 2011
Last updated: NA
Last verified: December 2010
History: No changes posted
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 Intervention
Exudative Age-related Macular Degeneration
Drug: Bevacizumab 1
Drug: Bevacizumab

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single Blind (Participant)
Primary Purpose: Treatment
Official Title: Randomized Multi-center Clinical Study:Bevacizumab for Neovascular Age-related Macular Degeneration

Resource links provided by NLM:

Further study details as provided by Peking University People's Hospital:

Primary Outcome Measures:
  • 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:
  • 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

Enrollment: 210
Study Start Date: January 2008
Study Completion Date: December 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


Ages Eligible for Study:   50 Years to 90 Years   (Adult, Senior)
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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01306591

China, Beijing
Xiaoxin Li
Beijing, Beijing, China, 100044
Sponsors and Collaborators
Peking University People's Hospital
Study Chair: Xiaoxin Li, doctor Peking University People's Hospital
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Peking University People's Hospital Identifier: NCT01306591     History of Changes
Other Study ID Numbers: Bevacizumab for nAMD
Study First Received: March 1, 2011
Last Updated: March 1, 2011

Keywords provided by Peking University People's Hospital:
neovascular age-related macular degeneration
Multicenter Randomized Study

Additional relevant MeSH terms:
Macular Degeneration
Wet Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents processed this record on April 27, 2017