Macular Degeneration Clinical Trial
Official title:
Effects of Vascular Endothelial Growth Factor Antagonism With Ranibizumab or Bevacizumab in Patients With Neovascular Macular Degeneration
Verified date | May 2015 |
Source | University of Zurich |
Contact | n/a |
Is FDA regulated | No |
Health authority | Switzerland: Swissmedic |
Study type | Observational |
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.
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 |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
Switzerland | University Hospital Zurich, Division of Cardiology | Zurich | ZH |
Lead Sponsor | Collaborator |
---|---|
University of Zurich |
Switzerland,
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 |
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