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Macular DegenerationREVIEWNCT01933152

Study to Assess the EffectiVeness of exIsting Anti-vascular Endothelial groWth Factor (Anti-VEGF) Treatment Regimens in Patients With Wet Age-related Macular Degeneration

An observational study of Macular Degeneration, run by Bayer at 1 site in Portugal.

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

Retrospective, non-interventional, observational multi-center field study. Patients diagnosed with wet Age-related macular degeneration (wAMD) and having started treatment with ranibizumab between January 1, 2009 and December 31, 2009 must be consecutively screened and, if eligible, enrolled. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Macular Degeneration
What is being tested?
Ranibizumab
How many people
137 participants
Where
1 sitePortugal
Study dates
Aug 2012to Apr 2013
Phase
Observational
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients must have been diagnosed to suffer from wet AMD and must have started anti-VEGF treatment with ranibizumab between January 1, 2009, and December 31, 2009

Who may be able to join

  • Diagnosis of wet Age-related Macular Degeneration
  • Start of anti-VEGF therapy with ranibizumab (Lucentis) between January 1, 2009 and December 31, 2009
  • Informed consent form signed

Who cannot join

  • Participation in an investigational study during anti-VEGF therapy (from start up to December 31, 2011) that involved treatment with any drug or device

Trial locations and contacts

1 site in 1 country.

Portugal1 site

  • Study site

    Many Locations

Other trials in Portugal

About this study

Official title: Review Study: A Retrospective Noninterventional Study to Assess the EffectiVeness of exIsting Anti-vascular Endothelial groWth Factor (Anti-VEGF) Treatment Regimens in Patients With Wet Age-related Macular Degeneration

Retrospective, non-interventional, observational multi-center field study. Patients diagnosed with wet Age-related macular degeneration (wAMD) and having started treatment with ranibizumab between January 1, 2009 and December 31, 2009 must be consecutively screened and, if eligible, enrolled. Patients will be followed up at maximum until December 31, 2011. Switch to any other Anti vascular endothelial growth factor (anti VEGF) treatment will be documented. For each patient, demographics, medical history, administered treatments, results of ocular and visual assessments and other tests (where available) will be documented.

Being tested
Ranibizumab
Keywords
wAMD, anti-VEGF
Medical subject headings
Macular Degeneration

What participants receive

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

  • RanibizumabDrug

    Patients with wet AMD treated with ranibizumab as prescribed by physician

Study groups in NCT01933152
Study groupRoleWhat they receive
Group 1Not described
Receives: Drug: Ranibizumab

What is being measured

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

  1. Changes in visual acuity after start of Anti vascular endothelial growth factor (anti VEGF) therapy with ranibizumab, assessed by Early Treatment Diabetic Retinopathy (ETDRS) or Snellen chard

    Measured: Baseline and 24 months

Secondary outcomes (8)

  1. Demographic characteristics of patients included in the study (Age, Sex, Race)

    Measured: Baseline

  2. Mean time from first clinical presentation to diagnosis

    Measured: Baseline

  3. Mean time from diagnosis to treatment

    Measured: Time from diagnosis to treatment: Up to 24 months

  4. Mean time from diagnosis to end of follow-up

    Measured: Time from diagnosis to end of follow-up: up to 48 months

  5. Mean change of visual acuity, from diagnosis to end of follow-up, assessed by Early Treatment Diabetic Retinopathy (ETDRS) or Snellen chart

    Measured: Baseline and 24 months

  6. Mean change of retinal thickness from diagnosis to end of follow-up, assessed by Optical Coherence Tomography (OCT)

    Measured: Baseline and 24 months

  7. Mean change of lesion size from diagnosis to end of follow-up, assessed by Fluorescein Angiography (FA)

    Measured: Baseline and 24 months

  8. Average number of treatments given from diagnosis to end of follow-up

    Measured: After 24 months

Timeline

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

  1. First posted2 Sep 2013 (estimated)
  2. Study startAug 2012
  3. Primary completionApr 2013
  4. Study completionApr 2013

Resources

More details

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

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
137 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01933152
Sponsor's protocol ID
16378
Acronym
REVIEW
Status last verified
Sep 2014
First submitted
29 Jul 2013
Last updated
1 Oct 2014
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

An observational study of Macular Degeneration, run by Bayer at 1 site in Portugal.

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 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 1 Oct 2014. 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 Portugal. 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?

Changes in visual acuity after start of Anti vascular endothelial growth factor (anti VEGF) therapy with ranibizumab, assessed by Early Treatment Diabetic Retinopathy (ETDRS) or Snellen chard (time frame: Baseline and 24 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 NCT01933152.

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 Oct 2014.

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