VEGF-antagonism and Endothelial Function in Age-related Macular Degeneration (AMD)
Effects of Vascular Endothelial Growth Factor Antagonism With Ranibizumab or Bevacizumab in Patients With Neovascular Macular Degeneration
1 other identifier
observational
54
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jul 2008
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2008
CompletedFirst Submitted
Initial submission to the registry
July 31, 2008
CompletedFirst Posted
Study publicly available on registry
August 4, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2013
CompletedMay 28, 2015
May 1, 2015
4.4 years
July 31, 2008
May 27, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (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.
8 weeks
Secondary Outcomes (1)
Change in cardiovascular and ophthalmological parameters.
8 weeks
Study Arms (3)
Ranibizumab
Bevacizumab
Dry AMD
Interventions
Eligibility Criteria
See eleigibility criteria
You may qualify if:
- 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
- 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
You may not qualify if:
- 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
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Hospital Zurich, Division of Cardiology
Zurich, Canton of Zurich, 8091, Switzerland
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Frank Ruschitzka, Prof MD
University Hospital Zurich, Division of Cardiology
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 31, 2008
First Posted
August 4, 2008
Study Start
July 1, 2008
Primary Completion
December 1, 2012
Study Completion
October 1, 2013
Last Updated
May 28, 2015
Record last verified: 2015-05