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OpenTrials
Completed

NCT Number: NCT00727753

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

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Zurich, Division of Cardiology

Zurich, Canton of Zurich, 8091, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ranibizumab

Drug

ranibizumab (0.5 mg) will be injected intraocular

Other names: Lucentis

Bevacizumab

Drug

Bevacizumab (1.25 mg) will be injected intraocular

Other names: Avastin

No treatment

Other

No treatment

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.

    Time frame: 8 weeks

Secondary outcomes

  1. Change in cardiovascular and ophthalmological parameters.

    Time frame: 8 weeks

    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.

Sponsors and collaborators

Lead sponsor

University of Zurich

Other

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2012
Study completion
2013
First posted
Aug 4, 2008
Registry last updated
May 28, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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