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

This study is currently recruiting participants.
Verified December 2012 by University of Zurich
Sponsor:
Information provided by (Responsible Party):
University of Zurich
ClinicalTrials.gov Identifier:
NCT00727753
First received: July 31, 2008
Last updated: December 11, 2012
Last verified: December 2012
History of Changes
  Purpose

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: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Vascular Endothelial Growth Factor Antagonism With Ranibizumab or Bevacizumab in Patients With Neovascular Macular Degeneration

Resource links provided by NLM:

U.S. FDA Resources

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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Change in inflammation markers, in oxidative stress, in mean, systolic und diastolic 24-hour blood pressure, in vascular compliance. Correlation of endothelial function with the number of endothelial progenitor cells. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 75
Study Start Date: July 2008
Estimated Study Completion Date: January 2013
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Ranibizumab Drug: Ranibizumab
ranibizumab (0.5 mg) will be injected intraocular
Other Name: Lucentis
Active Comparator: Bevacizumab Drug: Bevacizumab
Bevacizumab (1.25 mg) will be injected intraocular
Other Name: Avastin
Sham Comparator: Dry AMD Other: No treatment
No treatment
Other Name: No treatment

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00727753

Contacts
Contact: Frank Ruschitzka, Prof. MD frank.ruschitzka@usz.ch

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

No publications provided

Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT00727753     History of Changes
Other Study ID Numbers: EK-770
Study First Received: July 31, 2008
Last Updated: December 11, 2012
Health Authority: Switzerland: Swissmedic

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

Additional relevant MeSH terms:
Macular Degeneration
Wet Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Endothelial Growth Factors
Bevacizumab
Growth Substances
 Physiological Effects of Drugs
Pharmacologic Actions
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Inhibitors
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 21, 2013