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

Tracking Information

First Received Date ^ICMJE

July 31, 2008

Last Updated Date

December 11, 2012

Start Date ^ICMJE

July 2008

Primary Completion Date

December 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00727753 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Effects of Vascular Endothelial Growth Factor Antagonism With Ranibizumab or Bevacizumab in Patients With Neovascular Macular Degeneration

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

Macular Degeneration

Intervention ^ICMJE

Drug: Ranibizumab
ranibizumab (0.5 mg) will be injected intraocular

Other Name: Lucentis
Drug: Bevacizumab
Bevacizumab (1.25 mg) will be injected intraocular

Other Name: Avastin
Other: No treatment
No treatment

Other Name: No treatment

Study Arm (s)

Active Comparator: Ranibizumab
Intervention: Drug: Ranibizumab
Active Comparator: Bevacizumab
Intervention: Drug: Bevacizumab
Sham Comparator: Dry AMD
Intervention: Other: No treatment

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

January 2013

Primary Completion Date

December 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Both

Ages

18 Years to 80 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Frank Ruschitzka, Prof. MD

frank.ruschitzka@usz.ch

Location Countries ^ICMJE

Switzerland

Administrative Information

NCT Number ^ICMJE

NCT00727753

Other Study ID Numbers ^ICMJE

EK-770

Has Data Monitoring Committee

Responsible Party

University of Zurich

Study Sponsor ^ICMJE

University of Zurich

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Frank Ruschitzka, Prof MD

University Hospital Zurich, Division of Cardiology

Information Provided By

University of Zurich

Verification Date

December 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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