The Effects of Bevacizumab and Ranibizumab on Ocular Pulse Amplitude in Neovascular Age Related Macular Degeneration (AMD)
NCT ID: NCT00640640
Last Updated: 2008-03-21
Study Results
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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UNKNOWN
NA
60 participants
INTERVENTIONAL
2007-08-31
2009-02-28
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
NONE
Study Groups
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A
All study patients will be evaluated in a similar way
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
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
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
Interventions
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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
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
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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Willing and able to sign an inform consent
Exclusion Criteria
2. In the presently bevacizumab/ranibizumab treated eye, prior PDT and/or intravitreal Kenalog, during the last 3 months.
3. History of ocular surgery with the following exception: extra capsular cataract extraction with implantation of a posterior chamber intra-ocular lens.
4. History of ocular laser treatment, with the following exceptions: Posterior capsulotomy following cataract surgery.
5. Cataract or other media opacity precluding adequate fundus visualization of both eyes
50 Years
ALL
No
Sponsors
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Universitaire Ziekenhuizen KU Leuven
OTHER
Sheba Medical Center
OTHER_GOV
Responsible Party
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Goldschleger Eye Institute, Sheba Medical Center
Principal Investigators
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Ehud Rechtman, MD
Role: PRINCIPAL_INVESTIGATOR
Sheba Medical Center
Locations
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University Hospitals Leuven
Leuven, , Belgium
Goldschleger Eye Institute Sheba Medical Center
Ramat Gan, , Israel
Countries
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Central Contacts
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Facility Contacts
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Ingeborg Stalmans, MD, PhD
Role: primary
Ehud Rechtman, MD
Role: primary
Other Identifiers
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SHEBA-07-4739-ER-CTIL
Identifier Type: -
Identifier Source: org_study_id