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Age Related Macular DegenerationPhase 3LOW-VISIONNCT01327222

Intravitreal Bevacizumab for Low Vision in Neovascular Age-related Macular Degeneration (AMD)

A Phase 3 study testing Bevacizumab in people with Age Related Macular Degeneration, run by IRCCS San Raffaele at 1 site in Italy.

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

The purpose of this study is to compare the effectiveness of intravitreal bevacizumab injection (IVBI) with respect to simple observation in patients with subfoveal choroidal neovascularisation (CNV) secondary to age-related macular degeneration (AMD) presenting at baseline with best corrected visual acuity (BCVA)… Read more about this study

Who is it for?
Ages 55 to 90 years
Conditions the study is for
Age Related Macular Degeneration
What is being tested?
Bevacizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteItaly
Study dates
Feb 2011to Feb 2011
Phase
Phase 3
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 55 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • age-related macular degeneration
  • naïve subfoveal choroidal neovascularization
  • best-corrected visual acuity less then 20/200

Who cannot join

  • previous treatments
  • any other condition able to limit the visual improvement

Trial locations and contacts

1 site in 1 country.

Italy1 site

  • IRCCS San Raffaele

    Milan, MI, 20132

Other trials in Italy

About this study

Official title: Intravitreal Bevacizumab for the Treatment of Patients With Low Vision Due to Neovascular Age-related Macular Degeneration

The purpose of this study is to compare the effectiveness of intravitreal bevacizumab injection (IVBI) with respect to simple observation in patients with subfoveal choroidal neovascularisation (CNV) secondary to age-related macular degeneration (AMD) presenting at baseline with best corrected visual acuity (BCVA) less than 20/200.

Read the detailed description

There is no clear indication regarding the treatment of patients with subfoveal choroidal neovascularisation (CNV) secondary to age-related macular degeneration (AMD) presenting at baseline with best corrected visual acuity (BCVA) less than 20/200.

Treatment of eyes with low visual acuity could lead to a waste of resources, without any functional and social improvements.

Aim of the present study is to compare the effectiveness of intravitreal bevacizumab injection (IVBI) with respect to simple observation in

Being tested
Bevacizumab
Keywords
age-related macular degeneration, bevacizumab
Medical subject headings
Macular Degeneration

What participants receive

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

  • BevacizumabDrug

    Also called avastin

    1.25 mg intravitreal bevacizumab

Study groups in NCT01327222
Study groupRoleWhat they receive
bevacizumabExperimentalthree-monthly intravitreal bevacizumab, followed by PRN monthly injection on the basis of the detection of any fluid on the optical coherence tomography
Receives: Drug: Bevacizumab
controlNo interventionmonthly follow-up

What is being measured

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

  1. change in best-corrected visual acuity

    change in best-corrected visual acuity at the end of the follow-up

    Measured: 6 months

Secondary outcomes (2)

  1. change in central macular thickness

    change in central macular thickness on OCT

    Measured: 6 months

  2. NEI VFQ-25 scores

    change in NEI VFQ-25 scores questionnaire

    Measured: 6 months

Timeline

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

  1. First posted1 Apr 2011 (estimated)
  2. Study startFeb 2011
  3. Primary completionFeb 2011
  4. Study completionFeb 2011

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01327222
Sponsor's protocol ID
LOW-VISION
Acronym
LOW-VISION
Status last verified
Jan 2011
First submitted
30 Mar 2011
Last updated
1 Apr 2011
Results posted
No
Data monitoring committee
No

Publications

  • Arevalo JF, Sanchez JG, Wu L, Berrocal MH, Alezzandrini AA, Restrepo N, Maia M, Farah ME, Brito M, Diaz-Llopis M, Rodriguez FJ, Reategui G, Iturralde-Iraola J, Udaondo-Mirete P; Pan-American Collaborative Retina Study Group. Intravitreal bevacizumab for subfoveal choroidal neovascularization in age-related macular degeneration at twenty-four months: the Pan-American Collaborative Retina Study. Ophthalmology. 2010 Oct;117(10):1974-81, 1981.e1. doi: 10.1016/j.ophtha.2010.01.056. Epub 2010 May 31.

    PubMed 20569989

  • Parodi MB, Cascavilla M, Papayannis A, Kontadakis DS, Bandello F, Iacono P. Intravitreal bevacizumab in advanced-stage neovascular age-related macular degeneration with visual acuity lower than 20/200. Arch Ophthalmol. 2012 Jul;130(7):934-5. doi: 10.1001/archophthalmol.2011.2617. No abstract available.

    PubMed 22776937

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Bevacizumab in people with Age Related Macular Degeneration, run by IRCCS San Raffaele at 1 site in Italy.

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 3 inclusion and 2 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 1 Apr 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 Italy. 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.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

change in best-corrected visual acuity (time frame: 6 months). 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 NCT01327222, which also lists 2 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 1 Apr 2011.

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