Macular DegenerationNCT01655589
VEGF Gene Association With Response to Neovascular Age-related Macular Degeneration With Anti-VEGF Agents
An observational study of Macular Degeneration, run by Institute of Vision, Brasil at 1 site in Brazil.
Trial summary
The main purpose of this study is to investigate the association between VEGF gene polymorphism and the response to intravitreal drugs in neovascular age-related macular degeneration. This is a retrospective review of patients treated between 2008 and 2012 at the Institute of Vision, in Belo Horizonte, Brazil. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Macular Degeneration
- How many people
- 74 participants
- Where
- 1 siteBrazil
- Study dates
- Jan 2008to not given
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Eye clinic in Belo Horizonte, Brazil
Who may be able to join
- Diagnosis of neovascular age-related macular degeneration
- Visual acuity better than 20/400
- Loading dose with three intravitreal injections of anti-VEGF agents, administred one per month over three months
- Follow-up period of at least six months
Who cannot join
- Choroidal neovascularization secondary to any other cause than age-related macular degeneration
- Eyes with polypoidal choroidal vasculopathy
- Eyes previously submitted to posterior vitrectomy
- Other diseases that could affect visual acuity
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Institute of Vision
Belo Horizonte, Minas Gerais, 30150270
Andre B Ferreira, 55 31 32743355, andre@ivisao.com
About this study
Official title: VEGF Gene Polymorphism and Response to Intravitreal Anti-VEGF Agents in Neovascular Age-related Macular Degeneration
The main purpose of this study is to investigate the association between VEGF gene polymorphism and the response to intravitreal drugs in neovascular age-related macular degeneration. This is a retrospective review of patients treated between 2008 and 2012 at the Institute of Vision, in Belo Horizonte, Brazil.
- Conditions
- Macular Degeneration
- Medical subject headings
- Macular Degeneration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2012 (estimated)
- Study startJan 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Macular DegenerationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 74 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institute of Vision, Brasil
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01655589
- Sponsor's protocol ID
- IV-01
- Status last verified
- Jul 2012
- First submitted
- 31 Jul 2012
- Last updated
- 2 Aug 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- VEGF Gene Polymorphism and Response to Intravitreal Anti-VEGF Agents in Neovascular Age-related Macular Degeneration
- ClinicalTrials.gov ID
- NCT01655589
- Acronym / sponsor ID
- IV-01
- Conditions
- Macular Degeneration
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 74 participants (estimated)
- Lead sponsor
- Institute of Vision, BrasilUniversity, hospital or other
- Study start
- Jan 2008
- First posted
- 2 Aug 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main purpose of this study is to investigate the association between VEGF gene polymorphism and the response to intravitreal drugs in neovascular age-related macular degeneration. This is a retrospective review of patients treated between 2008 and 2012 at the Institute of Vision, in Belo Horizonte, Brazil.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Eye clinic in Belo Horizonte, Brazil
Key inclusion criteria (4 listed)
- Diagnosis of neovascular age-related macular degeneration
- Visual acuity better than 20/400
- Loading dose with three intravitreal injections of anti-VEGF agents, administred one per month over three months
- Follow-up period of at least six months
Key exclusion criteria (4 listed)
- Choroidal neovascularization secondary to any other cause than age-related macular degeneration
- Eyes with polypoidal choroidal vasculopathy
- Eyes previously submitted to posterior vitrectomy
- Other diseases that could affect visual acuity
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Macular Degeneration, run by Institute of Vision, Brasil at 1 site in Brazil.
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 4 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 2 Aug 2012. 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 Brazil. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
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 Aug 2012.