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

This study has been completed.
Information provided by (Responsible Party):
University of Zurich Identifier:
First received: July 31, 2008
Last updated: May 27, 2015
Last verified: May 2015
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.

Condition Intervention Phase
Macular Degeneration
Drug: Ranibizumab
Drug: Bevacizumab
Other: No treatment
Phase 4

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Effects of Vascular Endothelial Growth Factor Antagonism With Ranibizumab or Bevacizumab in Patients With Neovascular Macular Degeneration

Resource links provided by NLM:

Further study details as provided by University of Zurich:

Primary Outcome 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 Outcome 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.

Enrollment: 54
Study Start Date: July 2008
Study Completion Date: October 2013
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Ranibizumab Drug: Ranibizumab
ranibizumab (0.5 mg) will be injected intraocular
Other Name: Lucentis
Bevacizumab Drug: Bevacizumab
Bevacizumab (1.25 mg) will be injected intraocular
Other Name: Avastin
Dry AMD Other: No treatment
No treatment


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
See eleigibility 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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00727753

University Hospital Zurich, Division of Cardiology
Zurich, ZH, Switzerland, 8091
Sponsors and Collaborators
University of Zurich
Principal Investigator: Frank Ruschitzka, Prof MD University Hospital Zurich, Division of Cardiology
  More Information

Responsible Party: University of Zurich Identifier: NCT00727753     History of Changes
Other Study ID Numbers: EK-770
Study First Received: July 31, 2008
Last Updated: May 27, 2015

Keywords provided by University of Zurich:
Macular Degeneration
Age-Related Maculopathies

Additional relevant MeSH terms:
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Endothelial Growth Factors
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents
Immunologic Factors processed this record on May 25, 2017