Status:
COMPLETED
VEGF-antagonism and Endothelial Function in Age-related Macular Degeneration (AMD)
Lead Sponsor:
University of Zurich
Conditions:
Macular Degeneration
Eligibility:
All Genders
18-80 years
Brief 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 pa...
Eligibility Criteria
Inclusion
- Inclusion Criteria for active treatment:
- 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
- Inclusion criteria for controls:
- 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 for all subjects:
- 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
- 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
Exclusion
Key Trial Info
Start Date :
July 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 1 2013
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT00727753
Start Date
July 1 2008
End Date
October 1 2013
Last Update
May 28 2015
Active Locations (1)
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1
University Hospital Zurich, Division of Cardiology
Zurich, Canton of Zurich, Switzerland, 8091