Macular DegenerationNCT00709657
The Effect of a Single Intravitreal Anti-VEGF Therapy on Optic Nerve Head Perfusion
A study testing ranibizumab, bevacizumab or pegaptanib in people with Macular Degeneration and Regional Blood Flow, run by Medical University of Vienna at 1 site in Austria.
Trial summary
Age related macula degeneration is one of the most common sight threatening diseases of the elderly. The so called wet form of AMD is caused by choroidal neovascularisation (CNV) of pathological vessels, which lead to leakage, bleeding and macular edema. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Macular Degeneration, Regional Blood Flow, Vascular Endothelial Growth Factor
- What is being tested?
- ranibizumab, bevacizumab or pegaptanib
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteAustria
- Study dates
- Mar 2008to Nov 2011
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 40 subjects ≥ 50 years of age
- Subjects with all angiographic subtypes of neovascular wet AMD, already scheduled for intravitreal anti-VEGF therapy in one eye
- Good central or eccentric fixation
Who cannot join
- History or previous Anti-VEGF therapy
- History or previous intravitreal injection with any drug
- Intraocular pressure ≥ 25
- Glaucoma
- History or presence of thromboembolic events
- Diabetes mellitus
- Blood donation during the previous 3 weeks
- Ametropy ≥ 6 dpt
Trial locations and contacts
1 site in 1 country.
Austria1 site
Department of Clinical Pharmacology, Medical University of Vienna
Vienna, 1090
About this study
Age related macula degeneration is one of the most common sight threatening diseases of the elderly. The so called wet form of AMD is caused by choroidal neovascularisation (CNV) of pathological vessels, which lead to leakage, bleeding and macular edema. Several lines of evidence suggest that vascular endothelial growth factor (VEGF) plays a key role in the induction CNV. Recent evidence indicates that overexpression of VEGF in the retinal pigment epithelium may lead to the development of CNV in experimental models, and intravitreal injection of a VEGF blocker prevents the development of experimental CNV. This hypothesis is also supported by the promising effects of anti-VEGF treatment in patients with choroidal neovascularisation. The substances currently in clinical use include ranibizumab (Lucentis®), bevacizumab (Avastin®) and pegaptanib (Macugen®).
However, from a physiological point of view, VEGF also serves as a survival factor for existing vessels and for neuronal cells. Moreover, it has been reported that VEGF induces vasodilatation, most probably by an increased production of nitric oxide. Accordingly one may hypothesize that anti-VEGF treatment is associated with ocular vasoconstriction with unknown long term results. Thus, in the current study, the investigators set out to investigate whether the ocular perfusion is affected by a single intravitreal anti-VEGF.
- Being tested
- ranibizumab, bevacizumab or pegaptanib
- Keywords
- Age-related macular degeneration, 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.
ranibizumab, bevacizumab or pegaptanibDrug
measurements are performed one week before and after anti-VEGF intravitreal injection
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | patients with age-related macular degeneration, which are already scheduled for intravitreal anti-VEGF therapy in one eye are measured before and after treatment. Receives: Drug: ranibizumab, bevacizumab or pegaptanib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Optic nerve head blood flow
Measured: before, one week after and three weeks after intravitreal injection with an anti-VEGF drug
Secondary outcomes (4)
Choroidal blood flow
Measured: before, one week after and three weeks after intravitreal injection with an anti-VEGF drug
Retrobulbar blood flow
Measured: before, one week after and three weeks after intravitreal injection with an anti-VEGF drug
Intraocular pressure
Measured: before, one week after and three weeks after intravitreal injection with an anti-VEGF drug
Systemic blood pressure
Measured: before, one week after and three weeks after intravitreal injection with an anti-VEGF drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2008 (estimated)
- Study startMar 2008
- Primary completionJul 2010
- Study completionNov 2011
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.
- 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gerhard Garhofer, Medical University of Vienna
- Investigators
- Gerhard Garhöfer, MD, Principal investigator, Depatement of Clinical Pharmacology, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00709657
- Sponsor's protocol ID
- OPHT-060707
- Status last verified
- Nov 2014
- First submitted
- 1 Jul 2008
- Last updated
- 14 Nov 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a Single Intravitreal Anti-VEGF Therapy on Optic Nerve Head Perfusion
- ClinicalTrials.gov ID
- NCT00709657
- Acronym / sponsor ID
- OPHT-060707
- Keywords
- Age-related macular degeneration, anti-VEGF
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- Mar 2008
- Primary completion
- Jul 2010 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 3 Jul 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 macula degeneration is one of the most common sight threatening diseases of the elderly. The so called wet form of AMD is caused by choroidal neovascularisation (CNV) of pathological vessels, which lead to leakage, bleeding and macular edema. Several lines of evidence suggest that vascular endothelial growth factor (VEGF) plays a key role in the induction CNV. Recent evidence indicates that overexpression of VEGF in the retinal pigment epithelium may lead to the development of CNV in experimental models, and intravitreal injection of a VEGF blocker prevents the development of experimental CNV. This hypothesis is also supported by the promising effects of anti-VEGF treatment in patients with choroidal neovascularisation. The substances currently in clinical use include ranibizumab (Lucentis®), bevacizumab (Avastin®) and pegaptanib (Macugen®).
However, from a physiological point of view, VEGF also serves as a survival factor for existing vessels and for neuronal cells. Moreover, it has been reported that VEGF induces vasodilatation, most probably by an increased production of nitric oxide. Accordingly one may hypothesize that anti-VEGF treatment is associated with ocular vasoconstriction with unknown long term results. Thus, in the current study, the investigators set out to investigate whether the ocular perfusion is affected by a single intravitreal anti-VEGF.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: ranibizumab, bevacizumab or pegaptanibpatients with age-related macular degeneration, which are already scheduled for intravitreal anti-VEGF therapy in one eye are measured before and after treatment. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 40 subjects ≥ 50 years of age
- Subjects with all angiographic subtypes of neovascular wet AMD, already scheduled for intravitreal anti-VEGF therapy in one eye
- Good central or eccentric fixation
Key exclusion criteria (8 listed)
- History or previous Anti-VEGF therapy
- History or previous intravitreal injection with any drug
- Intraocular pressure ≥ 25
- Glaucoma
- History or presence of thromboembolic events
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 |
|---|---|---|
| ranibizumab, bevacizumab or pegaptanibmeasurements are performed one week before and after anti-VEGF intravitreal injection | Drug | 1 |
Primary outcome
Optic nerve head blood flow
Time frame: before, one week after and three weeks after intravitreal injection with an anti-VEGF drug
4 secondary outcomes
Choroidal blood flow
Time frame: before, one week after and three weeks after intravitreal injection with an anti-VEGF drug
Retrobulbar blood flow
Time frame: before, one week after and three weeks after intravitreal injection with an anti-VEGF drug
Intraocular pressure
Time frame: before, one week after and three weeks after intravitreal injection with an anti-VEGF drug
Systemic blood pressure
Time frame: before, one week after and three weeks after intravitreal injection with an anti-VEGF drug
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 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.
Gerhard Garhöfer, MD principal investigator
Depatement of Clinical Pharmacology, Medical University of Vienna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ranibizumab, bevacizumab or pegaptanib in people with Macular Degeneration and Regional Blood Flow, 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 3 inclusion and 8 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: stopped early, as of the sponsor's last update on 14 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 stopped early. Results are not available in the source record.
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?
Optic nerve head blood flow (time frame: before, one week after and three weeks after intravitreal injection with an anti-VEGF drug). 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 14 Nov 2014.