Choroidal NeoVascularizationNCT00813514
Does Vascular Endothelial Growth Factor (VEGF) or Complement Factor H Gene Polymorphism Play a Role in the Treatment Success With VEGF Inhibitors in Patients With Choroidal NeoVascularization (CNV)?
A study testing VEGF genotyping in people with Choroidal NeoVascularization and Age-Related Macular Degeneration, run by Medical University of Vienna at 1 site in Austria.
Trial summary
Age related macular degeneration (AMD) is a multifactorial disease with a strong genetic component. Most importantly a genetic polymorphism in the gene encoding for the complement factor H (CFH) has been recently identified which is highly associated with an increased risk of developing AMD. Read more about this study
- Who is it for?
- Ages 50 to 90 years
- Conditions the study is for
- Choroidal NeoVascularization, Age-Related Macular Degeneration
- What is being tested?
- VEGF genotyping
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteAustria
- Study dates
- Jan 2009to Nov 2014
- 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
- Men and women aged over 50 years
- Angiographically verified neovascular AMD
- Active primary or recurrent subfoveal lesion with CNV secondary to AMD
- Activity to be proven by fluorescein angiography
- Best corrected visual acuity assessed using ETDRS charts of 20/40 to 20/320 in the study eye
- CNV to be treated with intravitreal ranibizumab
- Signed informed consent
Who cannot join
- Prior treatment with any intravitreal drug in the study eye
- Prior treatment with verteporfin photodynamic therapy in the study eye
- Prior treatment with systemic bevacizumab
- Prior treatment with any intravitreal drug or verteporfin photodynamic therapy in the non-study eye within the 3 moths before the study entry
- Laser photocoagulation within 1 month before study entry in the study eye
- Previous participation in any clinical trial within 1 month before the entry of the study
Show all 12Show fewer
- Subfoveal fibrosis or atrophy in the study eye
- CNV in either of the two eye due to causes other than AMD such as histoplasmosis or pathological myopia
- Retinal pigment epithelial tear involving the macula in the study eye
- Any concurrent intraocular condition in the study eye that could either require medical or surgical intervention during the 12 month study period or that could contribute to a loss of best corrected visual acuity over the 12 months study period (e.g. diabetic retinopathy, cataract, uncontrolled glaucoma). The decision on exclusion is to be based on the opinion of the local principal investigator.
- Active intraocular inflammation
- Acute angle-closure glaucoma or narrow angle glaucoma due to the risk of IOP elevation caused by the administration of tropicamide
Trial locations and contacts
1 site in 1 country.
Austria1 site
Department of Clinical Pharmacology, Medical University of Vienna
Vienna
About this study
Official title: Does VEGF or Complement Factor H Gene Polymorphism Play a Role in the Treatment Success With VEGF Inhibitors in Patients With CNV?
Age related macular degeneration (AMD) is a multifactorial disease with a strong genetic component. Most importantly a genetic polymorphism in the gene encoding for the complement factor H (CFH) has been recently identified which is highly associated with an increased risk of developing AMD. This Tyr402His polymorphism located on chromosome 1q31 has been implicated to play a role in the development of the disease.
For this purpose a total of 200 patients with wet AMD will be included in the study. As described in detail below, the current study aims to identify potentially non-responders to anti-VEGF therapy based on genetic analysis of VEGF polymorphism and complement factor H polymorphism.
- Being tested
- VEGF genotyping
- Keywords
- AMD, VEGF genotyping, complement H gene polymorphism, Vascular Endothelial Growth Factor A
- Medical subject headings
- Choroidal Neovascularization, Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VEGF genotypingGenetic
blood sample for gene analysis
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Open longitudinal study with observer masked analysis Receives: Genetic: VEGF genotyping |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual acuity using ETDRS charts
Measured: 2 x 5 minutes
Central retinal thickness (Optical coherence tomography)
Measured: 2 x 20 minutes
VEGF genotyping
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2008 (estimated)
- Study startJan 2009
- Primary completionNov 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Choroidal NeoVascularizationStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Investigators
- Leopold Schmetterer, Prof. Dr., Principal investigator, Department of Clinical Pharmacology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00813514
- Sponsor's protocol ID
- OPHT-270907
- Status last verified
- Nov 2014
- First submitted
- 22 Dec 2008
- Last updated
- 21 Nov 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does VEGF or Complement Factor H Gene Polymorphism Play a Role in the Treatment Success With VEGF Inhibitors in Patients With CNV?
- ClinicalTrials.gov ID
- NCT00813514
- Acronym / sponsor ID
- OPHT-270907
- Keywords
- AMD, VEGF genotyping, complement H gene polymorphism, Vascular Endothelial Growth Factor A
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 23 Dec 2008 (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.
Age related macular degeneration (AMD) is a multifactorial disease with a strong genetic component. Most importantly a genetic polymorphism in the gene encoding for the complement factor H (CFH) has been recently identified which is highly associated with an increased risk of developing AMD. This Tyr402His polymorphism located on chromosome 1q31 has been implicated to play a role in the development of the disease.
For this purpose a total of 200 patients with wet AMD will be included in the study. As described in detail below, the current study aims to identify potentially non-responders to anti-VEGF therapy based on genetic analysis of VEGF polymorphism and complement factor H polymorphism.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Genetic: VEGF genotypingOpen longitudinal study with observer masked analysis |
Who may qualify
- Ages
- 50 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Men and women aged over 50 years
- Angiographically verified neovascular AMD
- Active primary or recurrent subfoveal lesion with CNV secondary to AMD
- Activity to be proven by fluorescein angiography
- Best corrected visual acuity assessed using ETDRS charts of 20/40 to 20/320 in the study eye
Key exclusion criteria (12 listed)
- Prior treatment with any intravitreal drug in the study eye
- Prior treatment with verteporfin photodynamic therapy in the study eye
- Prior treatment with systemic bevacizumab
- Prior treatment with any intravitreal drug or verteporfin photodynamic therapy in the non-study eye within the 3 moths before the study entry
- Laser photocoagulation within 1 month before study entry in the study eye
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VEGF genotypingblood sample for gene analysis | Genetic | 1 |
Primary outcome
Visual acuity using ETDRS charts
Time frame: 2 x 5 minutes
Central retinal thickness (Optical coherence tomography)
Time frame: 2 x 20 minutes
VEGF genotyping
Time frame: 1 week
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2014.
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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.
Leopold Schmetterer, Prof. Dr. principal investigator
Department of Clinical Pharmacology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VEGF genotyping in people with Choroidal NeoVascularization and Age-Related Macular Degeneration, run by Medical University of Vienna at 1 site in Austria.
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 7 inclusion and 12 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: withdrawn, as of the sponsor's last update on 21 Nov 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 Austria. 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 was withdrawn before enrolling participants, so there are no results.
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?
Visual acuity using ETDRS charts (time frame: 2 x 5 minutes). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
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 21 Nov 2014.