Clinical trial NCT00727753: VEGF-antagonism and Endothelial Function in Age-related Macular Degeneration (AMD)
Official title: Effects of Vascular Endothelial Growth Factor Antagonism With Ranibizumab or Bevacizumab in Patients With Neovascular Macular Degeneration
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Macular Degeneration
Keywords: Macular Degeneration
Age-Related Maculopathies
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2008-08-04
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: See eleigibility criteria

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.


Eligibility criteria: 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

Primary outcomes:
measure: 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.
timeFrame: 8 weeks
Secondary outcomes:
measure: Change in cardiovascular and ophthalmological parameters.
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: University Hospital Zurich, Division of Cardiology
state: ZH
Study officials:
affiliation: University Hospital Zurich, Division of Cardiology
name: Frank Ruschitzka, Prof MD
role: PRINCIPAL_INVESTIGATOR
References: