VEGF-antagonism and Endothelial Function in Age-related Macular Degeneration (AMD)
NCT ID: NCT00727753
Last Updated: 2015-05-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
54 participants
OBSERVATIONAL
2008-07-31
2013-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Ranibizumab
Ranibizumab
ranibizumab (0.5 mg) will be injected intraocular
Bevacizumab
Bevacizumab
Bevacizumab (1.25 mg) will be injected intraocular
Dry AMD
No treatment
No treatment
Interventions
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Ranibizumab
ranibizumab (0.5 mg) will be injected intraocular
Bevacizumab
Bevacizumab (1.25 mg) will be injected intraocular
No treatment
No treatment
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* "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
Exclusion Criteria
* 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
* 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
18 Years
80 Years
ALL
No
Sponsors
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University of Zurich
OTHER
Responsible Party
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Principal Investigators
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Frank Ruschitzka, Prof MD
Role: PRINCIPAL_INVESTIGATOR
University Hospital Zurich, Division of Cardiology
Locations
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University Hospital Zurich, Division of Cardiology
Zurich, Canton of Zurich, Switzerland
Countries
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Other Identifiers
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EK-770
Identifier Type: -
Identifier Source: org_study_id
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