Macular DegenerationNCT00727753
VEGF-antagonism and Endothelial Function in Age-related Macular Degeneration (AMD)
An observational study of Macular Degeneration, run by University of Zurich at 1 site in Switzerland.
Trial summary
The objective of this study is to evaluate the effects of 2 intravitreal injections with Ranibizumab or Avastin on endothelial function in subjects with neovascular macular degeneration compared to patients with dry AMD. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Macular Degeneration
- What is being tested?
- Ranibizumab, Bevacizumab and No treatment
- How many people
- 54 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jul 2008to Oct 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: See eleigibility criteria
Who may be able to join
- Age: 50 - 80 years
- Diagnosis of neovascular macular degeneration suitable for intravitreal anti-VEGF therapy
- Stable medication for general conditions for at least 1 month
- Written informed consent for participation in the study
- Age: 50 - 80 years
- Diagnosis of "dry" AMD
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- "dry" AMD is defined as at least Age-Related-Eye-Disease-Study (AREDS) category 2 in both eyes and no evidence of neovascularization in either eye
- Stable medication for general conditions for at least 1 month
- Written informed consent for participation in the study
Who cannot join
- Myocardial infarction, unstable angina, stroke within 3 months prior to study entry
- Thoracic or cardiac surgery and/or coronary intervention/revascularisation procedure (within 3 months before randomization)
- Uncontrolled symptomatic congestive heart failure (NHYA> II) in the last 4 weeks prior to study
- Renal insufficiency (Creatinine Clearance < 50ml/min)
- Ventricular tachyarrhythmias
- Poorly controlled hypertension, defined as resting blood pressure ≥ 160/100 mmHg
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- Symptomatic hypotension
- Long acting nitrates
- Smoking (>5 Zig./d)
- Diabetes mellitus
- Dyslipidemia (LDL-cholesterol > 4.5 mmol/l)
- Liver disease (ALT or AST >3x ULN)
- Alcohol or drug abuse
- Hypersensitivity to the active substance or to any of the excipients
- Active or suspected ocular or periocular infections
- Patients with active severe intraocular inflammation
- Malignancy (unless healed or remission > 5 years)
- Disease with systemic inflammation (e.g. rheumatoid arthritis, M. Crohn)
- Participation in another study within the last month
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Hospital Zurich, Division of Cardiology
Zurich, Canton of Zurich, 8091
About this study
Official title: Effects of Vascular Endothelial Growth Factor Antagonism With Ranibizumab or Bevacizumab in Patients With Neovascular Macular Degeneration
The objective of this study is to evaluate the effects of 2 intravitreal injections with Ranibizumab or Avastin on endothelial function in subjects with neovascular macular degeneration compared to patients with dry AMD.
- Conditions
- Macular Degeneration
- Being tested
- Ranibizumab, Bevacizumab, No treatment
- Keywords
- Macular Degeneration, Age-Related Maculopathies
- 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
Also called Lucentis
ranibizumab (0.5 mg) will be injected intraocular
BevacizumabDrug
Also called Avastin
Bevacizumab (1.25 mg) will be injected intraocular
No treatmentOther
No treatment
| Study group | Role | What they receive |
|---|---|---|
| Ranibizumab | Not described Receives: Drug: Ranibizumab | |
| Bevacizumab | Not described Receives: Drug: Bevacizumab | |
| Dry AMD | Not described Receives: Other: No treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of endothelial function after 2 intravitreal injections and 8 weeks follow-up with ranibizumab or bevacizumab in patients with neovascular macular degeneration compared to patients with dry AMD.
Measured: 8 weeks
Secondary outcomes (1)
Change in cardiovascular and ophthalmological parameters.
Secondary outcomes include evaluation of retinal thickness as measured by optical coherence tomography (OCT), change in best-corrected visual acuity (BCVA), "Early Treatment Diabetic Retinopathy Study" (ETDRS) letters, ambulatory blood pressure, vascular compliance, biomarkers of vascular function and platelet function.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2008 (estimated)
- Study startJul 2008
- Primary completionDec 2012
- Study completionOct 2013
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 University of ZurichThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Frank Ruschitzka, Prof MD, Principal investigator, University Hospital Zurich, Division of Cardiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00727753
- Sponsor's protocol ID
- EK-770
- Status last verified
- May 2015
- First submitted
- 31 Jul 2008
- Last updated
- 28 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Vascular Endothelial Growth Factor Antagonism With Ranibizumab or Bevacizumab in Patients With Neovascular Macular Degeneration
- ClinicalTrials.gov ID
- NCT00727753
- Acronym / sponsor ID
- EK-770
- Conditions
- Macular Degeneration
- Keywords
- Macular Degeneration, Age-Related Maculopathies
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- Jul 2008
- Primary completion
- Dec 2012 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 4 Aug 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.
The objective of this study is to evaluate the effects of 2 intravitreal injections with Ranibizumab or Avastin on endothelial function in subjects with neovascular macular degeneration compared to patients with dry AMD.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Ranibizumab | – | Drug: Ranibizumab |
| Bevacizumab | – | Drug: Bevacizumab |
| Dry AMD | – | Other: No treatment |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- See eleigibility criteria
Key inclusion criteria (9 listed)
- Age: 50 - 80 years
- Diagnosis of neovascular macular degeneration suitable for intravitreal anti-VEGF therapy
- Stable medication for general conditions for at least 1 month
- Written informed consent for participation in the study
- Age: 50 - 80 years
Key exclusion criteria (19 listed)
- Myocardial infarction, unstable angina, stroke within 3 months prior to study entry
- Thoracic or cardiac surgery and/or coronary intervention/revascularisation procedure (within 3 months before randomization)
- Uncontrolled symptomatic congestive heart failure (NHYA> II) in the last 4 weeks prior to study
- Renal insufficiency (Creatinine Clearance < 50ml/min)
- Ventricular tachyarrhythmias
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 |
|---|---|---|
| RanibizumabAlso: Lucentisranibizumab (0.5 mg) will be injected intraocular | Drug | Ranibizumab |
| BevacizumabAlso: AvastinBevacizumab (1.25 mg) will be injected intraocular | Drug | Bevacizumab |
| No treatmentNo treatment | Other | Dry AMD |
Primary outcome
Change of endothelial function after 2 intravitreal injections and 8 weeks follow-up with ranibizumab or bevacizumab in patients with neovascular macular degeneration compared to patients with dry AMD.
Time frame: 8 weeks
1 secondary outcome
Change in cardiovascular and ophthalmological parameters.
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2015.
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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.
Frank Ruschitzka, Prof MD principal investigator
University Hospital Zurich, Division of Cardiology
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 University of Zurich at 1 site in Switzerland.
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 9 inclusion and 19 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 28 May 2015. 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 Switzerland. 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?
Change of endothelial function after 2 intravitreal injections and 8 weeks follow-up with ranibizumab or bevacizumab in patients with neovascular macular degeneration compared to patients with dry AMD. (time frame: 8 weeks). 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 28 May 2015.