NCT01306591

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
210

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2008

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 1, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 2, 2011

Completed
Last Updated

March 2, 2011

Status Verified

December 1, 2010

Enrollment Period

2.4 years

First QC Date

March 1, 2011

Last Update Submit

March 1, 2011

Conditions

Exudative Age-related Macular Degeneration

Keywords

neovascular age-related macular degenerationBevacizumabMulticenter Randomized Study

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • macular thickness in OCT

    0week(baseline), 6week, 12week, 18week, 24week, 30week, 36week, 42week, 48week

Study Arms (2)

Bevacizumab 1

ACTIVE COMPARATOR
Drug: Bevacizumab 1

Bevacizumab 2

ACTIVE COMPARATOR
Drug: Bevacizumab

Interventions

Bevacizumab 1DRUG

Bevacizumab, 1.25mg/0.05ml, every 6 weeks, 42weeks

Bevacizumab 1
BevacizumabDRUG

Bevacizumab, 1.25mg/0.05ml, 0week(baseline), 6week, 12week, 24week, 36week

Bevacizumab 2

Eligibility Criteria

Age50 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • No other ocular fundus diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xiaoxin Li

Beijing, Beijing Municipality, 100044, China

Location

Related Publications (3)

  • 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.

    PMID: 32374423DERIVED

  • 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.

    PMID: 24069533DERIVED

  • 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.

    PMID: 22818896DERIVED

MeSH Terms

Interventions

Bevacizumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Xiaoxin Li, doctor

    Peking University People's Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 1, 2011

First Posted

March 2, 2011

Study Start

January 1, 2008

Primary Completion

June 1, 2010

Study Completion

December 1, 2010

Last Updated

March 2, 2011

Record last verified: 2010-12

Locations

CN(1)