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

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ClinicalTrials.gov Identifier: NCT00727753
Recruitment Status : Completed
First Posted : August 4, 2008
Last Update Posted : May 28, 2015
Sponsor:
Information provided by (Responsible Party):
University of Zurich

Brief 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.

Condition or disease Intervention/treatment
Macular Degeneration Drug: Ranibizumab Drug: Bevacizumab Other: No treatment

Study Type : Observational
Actual Enrollment : 54 participants
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
Study Start Date : July 2008
Actual Primary Completion Date : December 2012
Actual Study Completion Date : October 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort Intervention/treatment
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



Primary Outcome Measures :
  1. 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 :
  1. 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.



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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
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00727753


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

Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT00727753     History of Changes
Other Study ID Numbers: EK-770
First Posted: August 4, 2008    Key Record Dates
Last Update Posted: May 28, 2015
Last Verified: May 2015

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

Additional relevant MeSH terms:
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Bevacizumab
Ranibizumab
Endothelial Growth Factors
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents
Immunologic Factors