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

May 27, 2015 updated by: University of Zurich

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

54

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
    • ZH
      • Zurich, ZH, Switzerland, 8091
        • University Hospital Zurich, Division of Cardiology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

See eleigibility criteria

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Ranibizumab
Drug: Ranibizumab
ranibizumab (0.5 mg) will be injected intraocular
Other Names:
  • Lucentis
Bevacizumab
Drug: Bevacizumab
Bevacizumab (1.25 mg) will be injected intraocular
Other Names:
  • Avastin
Dry AMD
Other: No treatment
No treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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.
Time Frame: 8 weeks
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Zurich

Investigators

  • Principal Investigator: Frank Ruschitzka, Prof MD, University Hospital Zurich, Division of Cardiology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2008

Primary Completion (Actual)

December 1, 2012

Study Completion (Actual)

October 1, 2013

Study Registration Dates

First Submitted

July 31, 2008

First Submitted That Met QC Criteria

August 1, 2008

First Posted (Estimate)

August 4, 2008

Study Record Updates

Last Update Posted (Estimate)

May 28, 2015

Last Update Submitted That Met QC Criteria

May 27, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EK-770

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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