Bevacizumab for Neovascular Age-related Macular Degeneration

Exudative Age-related Macular Degeneration Clinical Trial

Official title:

Randomized Multi-center Clinical Study：Bevacizumab for Neovascular Age-related Macular Degeneration

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01306591
• Other study ID #: Bevacizumab for nAMD
• Status: Completed
• Phase: N/A
• First received: March 1, 2011
• Last updated: March 1, 2011
• Start date: January 2008
• Est. completion date: December 2010

Study information

• Verified date: December 2010
• Source: Peking University People's Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 210
• Est. completion date: December 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 90 Years

Eligibility

Inclusion Criteria:

• Clinical diagnosis of neovascular Age-related macular degeneration

• Signed informed consent

Exclusion Criteria:

• No other ocular fundus diseases

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Exudative Age-related Macular Degeneration
• Macular Degeneration
• Wet Macular Degeneration

Intervention

Drug:
• Bevacizumab 1
Bevacizumab, 1.25mg/0.05ml, every 6 weeks, 42weeks
• Bevacizumab
Bevacizumab, 1.25mg/0.05ml, 0week(baseline), 6week, 12week, 24week, 36week

Locations

Country	Name	City	State
China	Xiaoxin Li	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	EDTRS visual acuity score	EDTRS visual acuity score is assessed at each timepoint for every group	0week(baseline), 6week, 12week, 18week, 24week, 30week, 36week, 42week, 48week	Yes
Secondary	macular thickness in OCT	macular thickness is assessed at each timepoint for every group	0week(baseline), 6week, 12week, 18week, 24week, 30week, 36week, 42week, 48week	Yes