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Bevacizumab for Neovascular Age-related Macular Degeneration

Primary Purpose

Exudative Age-related Macular Degeneration

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Bevacizumab 1
Bevacizumab
Sponsored by
Peking University People's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Exudative Age-related Macular Degeneration focused on measuring neovascular age-related macular degeneration, Bevacizumab, Multicenter Randomized Study

Eligibility Criteria

50 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • No other ocular fundus diseases

Sites / Locations

  • Xiaoxin Li

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Bevacizumab 1

Bevacizumab 2

Arm Description

Outcomes

Primary Outcome Measures

EDTRS visual acuity score
EDTRS visual acuity score is assessed at each timepoint for every group

Secondary Outcome Measures

macular thickness in OCT
macular thickness is assessed at each timepoint for every group

Full Information

First Posted
March 1, 2011
Last Updated
March 1, 2011
Sponsor
Peking University People's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01306591
Brief Title
Bevacizumab for Neovascular Age-related Macular Degeneration
Official Title
Randomized Multi-center Clinical Study：Bevacizumab for Neovascular Age-related Macular Degeneration
Study Type
Interventional

2. Study Status

Record Verification Date
December 2010
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
June 2010 (Actual)
Study Completion Date
December 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Peking University People's Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Exudative Age-related Macular Degeneration
Keywords
neovascular age-related macular degeneration, Bevacizumab, Multicenter Randomized Study

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
Randomized
Enrollment
210 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bevacizumab 1
Arm Type
Active Comparator
Arm Title
Bevacizumab 2
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Bevacizumab 1
Intervention Description
Bevacizumab, 1.25mg/0.05ml, every 6 weeks, 42weeks
Intervention Type
Drug
Intervention Name(s)
Bevacizumab
Intervention Description
Bevacizumab, 1.25mg/0.05ml, 0week(baseline), 6week, 12week, 24week, 36week
Primary Outcome Measure Information:
Title
EDTRS visual acuity score
Description
EDTRS visual acuity score is assessed at each timepoint for every group
Time Frame
0week(baseline), 6week, 12week, 18week, 24week, 30week, 36week, 42week, 48week
Secondary Outcome Measure Information:
Title
macular thickness in OCT
Description
macular thickness is assessed at each timepoint for every group
Time Frame
0week(baseline), 6week, 12week, 18week, 24week, 30week, 36week, 42week, 48week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Clinical diagnosis of neovascular Age-related macular degeneration Signed informed consent Exclusion Criteria: No other ocular fundus diseases
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiaoxin Li, doctor
Organizational Affiliation
Peking University People's Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Xiaoxin Li
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100044
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
32374423
Citation
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.
Results Reference
derived
PubMed Identifier
24069533
Citation
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.
Results Reference
derived
PubMed Identifier
22818896
Citation
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.
Results Reference
derived

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Bevacizumab for Neovascular Age-related Macular Degeneration

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