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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00727753

Enrollment

Registered

2008-08-04

Start date

2008-07-31

Completion date

2013-10-31

Last updated

2015-05-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Macular Degeneration

Keywords

Macular Degeneration, Age-Related Maculopathies

Brief 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.

Interventions

DRUGRanibizumab

ranibizumab (0.5 mg) will be injected intraocular

DRUGBevacizumab

Bevacizumab (1.25 mg) will be injected intraocular

OTHERNo treatment

No treatment

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

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.	8 weeks

Secondary

Measure	Time frame	Description
Change in cardiovascular and ophthalmological parameters.	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.

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026