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Bevacizumab for Neovascular Age-related Macular Degeneration

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ClinicalTrials.gov Identifier: NCT01306591
Recruitment Status : Completed
First Posted : March 2, 2011
Last Update Posted : March 2, 2011
Sponsor:
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

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



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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
Criteria

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 ClinicalTrials.gov identifier (NCT number): NCT01306591


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Peking University People's Hospital
ClinicalTrials.gov Identifier: NCT01306591     History of Changes
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
Bevacizumab
Multicenter Randomized Study

Additional relevant MeSH terms:
Macular Degeneration
Wet Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Bevacizumab
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents