- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01306591
Bevacizumab for Neovascular Age-related Macular Degeneration
March 1, 2011 updated by: Peking University People's Hospital
Randomized Multi-center Clinical Study:Bevacizumab for Neovascular Age-related Macular Degeneration
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
210
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Beijing
-
Beijing, Beijing, China, 100044
- Xiaoxin Li
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
50 years to 90 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Clinical diagnosis of neovascular Age-related macular degeneration
- Signed informed consent
Exclusion Criteria:
- No other ocular fundus diseases
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Bevacizumab 1
|
Bevacizumab, 1.25mg/0.05ml,
every 6 weeks, 42weeks
|
Active Comparator: Bevacizumab 2
|
Bevacizumab, 1.25mg/0.05ml,
0week(baseline), 6week, 12week, 24week, 36week
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
0week(baseline), 6week, 12week, 18week, 24week, 30week, 36week, 42week, 48week
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
0week(baseline), 6week, 12week, 18week, 24week, 30week, 36week, 42week, 48week
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Chair: Xiaoxin Li, doctor, Peking University People's Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2008
Primary Completion (Actual)
June 1, 2010
Study Completion (Actual)
December 1, 2010
Study Registration Dates
First Submitted
March 1, 2011
First Submitted That Met QC Criteria
March 1, 2011
First Posted (Estimate)
March 2, 2011
Study Record Updates
Last Update Posted (Estimate)
March 2, 2011
Last Update Submitted That Met QC Criteria
March 1, 2011
Last Verified
December 1, 2010
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Bevacizumab for nAMD
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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