VEGF-antagonism and Endothelial Function in Age-related Macular Degeneration (AMD)

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.

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