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Exudative Age-related Macular DegenerationNCT01306591

Bevacizumab for Neovascular Age-related Macular Degeneration

A study testing Bevacizumab 1 and Bevacizumab in people with Exudative Age-related Macular Degeneration, run by Peking University People's Hospital at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 50 to 90 years
What is being tested?
Bevacizumab 1 and Bevacizumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
210 participants
Where
1 siteChina
Study dates
Jan 2008to Dec 2010
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • No other ocular fundus diseases

Trial locations and contacts

1 site in 1 country.

China1 site

  • Xiaoxin Li

    Beijing, Beijing Municipality, 100044

Other trials in China

About this study

Official title: 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.

Being tested
Bevacizumab 1, Bevacizumab
Keywords
neovascular age-related macular degeneration, Bevacizumab, Multicenter Randomized Study

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Bevacizumab 1Drug

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

  • BevacizumabDrug

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

Study groups in NCT01306591
Study groupRoleWhat they receive
Bevacizumab 1Active comparatorNot described
Receives: Drug: Bevacizumab 1
Bevacizumab 2Active comparatorNot described
Receives: Drug: Bevacizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. EDTRS visual acuity score

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

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

Secondary outcomes (1)

  1. macular thickness in OCT

    macular thickness is assessed at each timepoint for every group

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Mar 2011 (estimated)
  2. Study startJan 2008
  3. Primary completionJun 2010
  4. Study completionDec 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Single group
Masking
Single blind
Who is masked
Participant
Enrolment
210 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01306591
Sponsor's protocol ID
Bevacizumab for nAMD
Status last verified
Dec 2010
First submitted
1 Mar 2011
Last updated
2 Mar 2011
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 32374423

  • 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.

    PubMed 24069533

  • 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.

    PubMed 22818896

Questions about this trial

What is this clinical trial studying?

A study testing Bevacizumab 1 and Bevacizumab in people with Exudative Age-related Macular Degeneration, run by Peking University People's Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Mar 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

EDTRS visual acuity score (time frame: 0week(baseline), 6week, 12week, 18week, 24week, 30week, 36week, 42week, 48week). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01306591, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2011.

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