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

Macular Degeneration Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00727753
• Other study ID #: EK-770
• Status: Completed
• Phase: Phase 4
• First received: July 31, 2008
• Last updated: May 27, 2015
• Start date: July 2008
• Est. completion date: October 2013

Study information

• Verified date: May 2015
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Swissmedic
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: October 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Macular Degeneration
• Wet Macular Degeneration

Intervention

Drug:
• Ranibizumab
ranibizumab (0.5 mg) will be injected intraocular
• Bevacizumab
Bevacizumab (1.25 mg) will be injected intraocular

Other:
• No treatment
No treatment

Locations

Country	Name	City	State
Switzerland	University Hospital Zurich, Division of Cardiology	Zurich	ZH

Sponsors (1)

Lead Sponsor	Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Change in cardiovascular and ophthalmological parameters.	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.	8 weeks	No