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

  • China
    • 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
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

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.

Sponsor

Peking University People's Hospital

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

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

Keywords

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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