VEGF-antagonism and Endothelial Function in Age-related Macular Degeneration (AMD)
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ClinicalTrials.gov Identifier: NCT00727753 |
Recruitment Status :
Completed
First Posted : August 4, 2008
Last Update Posted : May 28, 2015
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Condition or disease | Intervention/treatment |
---|---|
Macular Degeneration | Drug: Ranibizumab Drug: Bevacizumab Other: No treatment |
Study Type : | Observational |
Actual Enrollment : | 54 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | Effects of Vascular Endothelial Growth Factor Antagonism With Ranibizumab or Bevacizumab in Patients With Neovascular Macular Degeneration |
Study Start Date : | July 2008 |
Actual Primary Completion Date : | December 2012 |
Actual Study Completion Date : | October 2013 |

Group/Cohort | Intervention/treatment |
---|---|
Ranibizumab |
Drug: Ranibizumab
ranibizumab (0.5 mg) will be injected intraocular
Other Name: Lucentis |
Bevacizumab |
Drug: Bevacizumab
Bevacizumab (1.25 mg) will be injected intraocular
Other Name: Avastin |
Dry AMD |
Other: No treatment
No treatment |
- 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 ]
- 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.

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Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00727753
Switzerland | |
University Hospital Zurich, Division of Cardiology | |
Zurich, ZH, Switzerland, 8091 |
Principal Investigator: | Frank Ruschitzka, Prof MD | University Hospital Zurich, Division of Cardiology |
Responsible Party: | University of Zurich |
ClinicalTrials.gov Identifier: | NCT00727753 |
Other Study ID Numbers: |
EK-770 |
First Posted: | August 4, 2008 Key Record Dates |
Last Update Posted: | May 28, 2015 |
Last Verified: | May 2015 |
Macular Degeneration Age-Related Maculopathies |
Macular Degeneration Retinal Degeneration Retinal Diseases Eye Diseases Bevacizumab Ranibizumab Antineoplastic Agents, Immunological |
Antineoplastic Agents Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Growth Inhibitors |