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

University of Zurich (UZH)

Status: Completed

Conditions: Macular Degeneration

Treatments: Drug: Bevacizumab; Drug: Ranibizumab; Other: No treatment

Study type: Observational

Funder types: Other

Identifiers

NCT00727753

EK-770

Details and patient eligibility

About

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.

Enrollment: 54 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

54 participants in 3 patient groups

Ranibizumab

Treatment:

Drug: Ranibizumab

Bevacizumab

Treatment:

Drug: Bevacizumab

Dry AMD

Treatment:

Other: No treatment