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

NCT ID: NCT00727753

Last Updated: 2015-05-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

54 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-07-31

Study Completion Date

2013-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Macular Degeneration

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Ranibizumab

Ranibizumab

Intervention Type DRUG

ranibizumab (0.5 mg) will be injected intraocular

Bevacizumab

Bevacizumab

Intervention Type DRUG

Bevacizumab (1.25 mg) will be injected intraocular

Dry AMD

No treatment

Intervention Type OTHER

No treatment

Interventions

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Ranibizumab

ranibizumab (0.5 mg) will be injected intraocular

Intervention Type DRUG

Bevacizumab

Bevacizumab (1.25 mg) will be injected intraocular

Intervention Type DRUG

No treatment

No treatment

Intervention Type OTHER

Other Intervention Names

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Lucentis Avastin

Eligibility Criteria

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Inclusion Criteria

* 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


* 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

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Zurich

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Frank Ruschitzka, Prof MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital Zurich, Division of Cardiology

Locations

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University Hospital Zurich, Division of Cardiology

Zurich, Canton of Zurich, Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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EK-770

Identifier Type: -

Identifier Source: org_study_id

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