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

Overview

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.

Full Title of Study: “Effects of Vascular Endothelial Growth Factor Antagonism With Ranibizumab or Bevacizumab in Patients With Neovascular Macular Degeneration”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: December 2012

Interventions

  • Drug: Ranibizumab
    • ranibizumab (0.5 mg) will be injected intraocular
  • Drug: Bevacizumab
    • Bevacizumab (1.25 mg) will be injected intraocular
  • Other: No treatment
    • No treatment

Arms, Groups and Cohorts

  • Ranibizumab
  • Bevacizumab
  • Dry AMD

Clinical Trial Outcome Measures

Primary Measures

  • Change of endothelial function after 2 intravitreal injections and 8 weeks follow-up with ranibizumab or bevacizumab in patients with neovascular macular degeneration compared to patients with dry AMD.
    • Time Frame: 8 weeks

Secondary Measures

  • Change in cardiovascular and ophthalmological parameters.
    • Time Frame: 8 weeks
    • Secondary outcomes include evaluation of retinal thickness as measured by optical coherence tomography (OCT), change in best-corrected visual acuity (BCVA), “Early Treatment Diabetic Retinopathy Study” (ETDRS) letters, ambulatory blood pressure, vascular compliance, biomarkers of vascular function and platelet function.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Zurich
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Frank Ruschitzka, Prof MD, Principal Investigator, University Hospital Zurich, Division of Cardiology

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