CClinicalTrials.gg
CompletedNCT00727753Updated May 28, 2015

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

An observational study in Macular Degeneration, sponsored by University of Zurich. Completed at 1 site in Switzerland. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2015-05-28.

Sponsored by University of Zurich · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
54
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Macular Degeneration

Keywords

  • Macular Degeneration
  • Age-Related Maculopathies
03

In context

Macular Degeneration

1,474 studies on the registry are indexed under Macular Degeneration; 206 are open to participants now.

This study's enrollment of 54 is below the median of 106 across 421 observational studies indexed under Macular Degeneration.

Browse Macular Degeneration studies →

Lead sponsor

University of Zurich is the lead sponsor of 1,030 studies on the registry; 130 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

See eleigibility criteria

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
54 participants (actual)
Patient registry
No

Groups and cohorts

  • Ranibizumab

    Drug: Ranibizumab

  • Bevacizumab

    Drug: Bevacizumab

  • Dry AMD

    Other: No treatment

Interventions

  • DrugRanibizumab

    ranibizumab (0.5 mg) will be injected intraocular

    Also known as: Lucentis

  • DrugBevacizumab

    Bevacizumab (1.25 mg) will be injected intraocular

    Also known as: Avastin

  • OtherNo treatment

    No treatment

06

What researchers measure

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.

    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.

    Time frame: 8 weeks

07

Study locations

1 site
  • University Hospital Zurich, Division of Cardiology
    Zurich, ZH 8091, Switzerland
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 28, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00727753
Lead sponsor
University of Zurich
Responsible party
Sponsor
First posted
Aug 4, 2008
Start date
Jul 2008
Primary completion
Dec 2012
Completion
Oct 2013
Last update
May 28, 2015

Study contacts

Frank Ruschitzka, Prof MD
principal investigator · University Hospital Zurich, Division of Cardiology

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2015. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion