The Effects of Bevacizumab and Ranibizumab on Ocular Pulse Amplitude in Neovascular Age Related Macular Degeneration (AMD) (AMD)
|ClinicalTrials.gov Identifier: NCT00640640|
Recruitment Status : Unknown
Verified March 2008 by Sheba Medical Center.
Recruitment status was: Recruiting
First Posted : March 21, 2008
Last Update Posted : March 21, 2008
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.
|Condition or disease||Intervention/treatment||Phase|
|Neovascular Age Related Macular Degeneration||Device: Pascal Dynamic Contour Tonometer Drug: Ranibizumab Drug: Bevacizumab||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Effect of Intravitreal Bevacizumab & Ranibizumab on Ocular Pulse Amplitude in Neovascular Age Related Macular Degeneration|
|Study Start Date :||August 2007|
|Estimated Primary Completion Date :||December 2008|
|Estimated Study Completion Date :||February 2009|
All study patients will be evaluated in a similar way
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
Other Name: Pascal Dynamic Contour Tonometer = Pascal DCT
measure the effect of intravitreal 0.5mg/0.05ml ranibizumab on the intraocular pressure and ocular pulse amplitude with the Pascal Dynamic Contour Tonometer
Other Name: Lucentis
measure the effect of intravitreal 1.25mg/0.05ml bevacizumab on the intraocular pressure and ocular pulse amplitude with the Pascal Dynamic Contour Tonometer
Other Name: Avastin
- Ocular pulse pressure (OPA)a week and month after intravitreal bevacizumab/ranibizumab, as compare to baseline OPA, just prior to treatment [ Time Frame: One month for each patient ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00640640
|Contact: Ehud Rechtman, MDfirstname.lastname@example.org|
|University Hospitals Leuven||Recruiting|
|Contact: Ingeborg Stalmans, MD, PhD|
|Goldschleger Eye Institute Sheba Medical Center||Recruiting|
|Ramat Gan, Israel, 52621|
|Contact: Ehud Rechtman, MD 972-52-2528871 email@example.com|
|Principal Investigator: Ehud Rechtman, MD|
|Principal Investigator:||Ehud Rechtman, MD||Sheba Medical Center|