Bevacizumab for Neovascular Age-related Macular Degeneration

This study has been completed.
Sponsor:
Information provided by:
Peking University People's Hospital
ClinicalTrials.gov Identifier:
NCT01306591
First received: March 1, 2011
Last updated: NA
Last verified: December 2010
History: No changes posted
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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

  Eligibility

Ages Eligible for Study:   50 Years to 90 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided by Peking University People's Hospital

Additional 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
Study First Received: March 1, 2011
Last Updated: March 1, 2011
Health Authority: China: Food and Drug Administration

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
Eye Diseases
Retinal Degeneration
Retinal Diseases
Bevacizumab
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Antineoplastic Agents
Growth Inhibitors
Growth Substances
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 22, 2014