NCT00640640

The Effects of Bevacizumab and Ranibizumab on Ocular Pulse Amplitude in Neovascular Age Related Macular Degeneration (AMD)

The Effect of Intravitreal Bevacizumab & Ranibizumab on Ocular Pulse Amplitude in Neovascular Age Related Macular Degeneration

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Sheba Medical Center · Other Government
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

One concern about repeated intravitreal injections of bevacizumab (Avastin) and ranibizumab (Lucentis) in wet age related macular degeneration, is that in addition to blocking the proteins that triggers the development and proliferation of abnormal vessels in the center of the retina, they may also result in changes in the normal vessels that feeds the outer part of the retina. Small vessels with fenestrations (such as those that feed the outer part of the retina, which are called choriocapillaris) appear to be especially sensitive to this protein (called vascular endothelial growth factor, VEGF) withdrawal. It is estimated that global blood flow in the vascular layer under the retina (called choroid) may be indirectly assessed by measuring the amplitude of the ocular pulsation (the pressure inside the eye change according to the cardiac cycle, similar to the change in blood pressure) which is called Ocular Pulse Amplitude (OPA). The Pascal Dynamic Contour Tonometer (Pascal DCT) is a new tonometer (a device which measures the pressure within the eye) designed to measure intraocular pressure and ocular pulse amplitude. No published study has yet assessed the effect of bevacizumab (Avastin) or ranibizumab (Lucentis) treatment for wet AMD (or on any other retinal disease) on OPA. This is our aim in this pilot study, in which we will measure the pressure within the eye just prior to bevacizumab/Ranibizumab treatment, followed by repeated measurements a week and a month after the treatment. For this purpose, up to 60 patients with wet AMD will be recruited.

Conditions

• Neovascular Age Related Macular Degeneration

Interventions

Type	Name	Description
DEVICE	Pascal Dynamic Contour Tonometer	Pascal Dynamic Contour Tonometer is an ocular device that is able to safely measure the intraocular pressure and the ocular pulse amplitude
DRUG	Ranibizumab	measure the effect of intravitreal 0.5mg/0.05ml ranibizumab on the intraocular pressure and ocular pulse amplitude with the Pascal Dynamic Contour Tonometer
DRUG	Bevacizumab	measure the effect of intravitreal 1.25mg/0.05ml bevacizumab on the intraocular pressure and ocular pulse amplitude with the Pascal Dynamic Contour Tonometer

Timeline

• Start date: 2007-08-01
• Primary completion: 2008-12-01
• Completion: 2009-02-01
• First posted: 2008-03-21
• Last updated: 2008-03-21

Locations

2 sites across 2 countries: Belgium, Israel