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

Study Overview
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Brief Summary
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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.

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

Conditions
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Macular Degeneration

Intervention / Treatment
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* Drug: Ranibizumab
* Drug: Bevacizumab
* Other: No treatment


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Ranibizumab<br> | Drug: Ranibizumab<br>* ranibizumab (0.5 mg) will be injected intraocular<br>* Other names: Lucentis;|
| Bevacizumab<br> | Drug: Bevacizumab<br>* Bevacizumab (1.25 mg) will be injected intraocular<br>* Other names: Avastin;|
| Dry AMD<br> | Other: No treatment<br>* No treatment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Macular Degeneration, Age-Related Maculopathies