Overview

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

Status:
Completed
Trial end date:
2013-10-01
Target enrollment:
0
Participant gender:
All
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.
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University of Zurich
Treatments:
Bevacizumab
Endothelial Growth Factors
Ranibizumab
Criteria
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