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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00727753
Other study ID # EK-770
Secondary ID
Status Completed
Phase Phase 4
First received July 31, 2008
Last updated May 27, 2015
Start date July 2008
Est. completion date October 2013

Study information

Verified date May 2015
Source University of Zurich
Contact n/a
Is FDA regulated No
Health authority Switzerland: Swissmedic
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 54
Est. completion date October 2013
Est. primary completion date December 2012
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 80 Years
Eligibility 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 Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Intervention

Drug:
Ranibizumab
ranibizumab (0.5 mg) will be injected intraocular
Bevacizumab
Bevacizumab (1.25 mg) will be injected intraocular
Other:
No treatment
No treatment

Locations

Country Name City State
Switzerland University Hospital Zurich, Division of Cardiology Zurich ZH

Sponsors (1)

Lead Sponsor Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Yes
Secondary 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 No
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