- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00640640
The Effects of Bevacizumab and Ranibizumab on Ocular Pulse Amplitude in Neovascular Age Related Macular Degeneration (AMD) (AMD)
The Effect of Intravitreal Bevacizumab & Ranibizumab on Ocular Pulse Amplitude in Neovascular Age Related Macular Degeneration
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Ehud Rechtman, MD
- Phone Number: 972-52-2528871
- Email: ehudrechtman@gmail.com
Study Locations
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Leuven, Belgium
- Recruiting
- University Hospitals Leuven
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Contact:
- Ingeborg Stalmans, MD, PhD
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Ramat Gan, Israel, 52621
- Recruiting
- Goldschleger Eye Institute Sheba Medical Center
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Contact:
- Ehud Rechtman, MD
- Phone Number: 972-52-2528871
- Email: ehudrechtman@gmail.com
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Principal Investigator:
- Ehud Rechtman, MD
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Male or female in the ages of 50 year or older
- Willing and able to sign an inform consent
Exclusion Criteria:
- Any history, signs or symptoms of any retinal or optic nerve disease, except AMD and mild hypertensive retinopathy
- In the presently bevacizumab/ranibizumab treated eye, prior PDT and/or intravitreal Kenalog, during the last 3 months.
- History of ocular surgery with the following exception: extra capsular cataract extraction with implantation of a posterior chamber intra-ocular lens.
- History of ocular laser treatment, with the following exceptions: Posterior capsulotomy following cataract surgery.
- Cataract or other media opacity precluding adequate fundus visualization of both eyes
Study Plan
How is the study designed?
Design Details
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: A
All study patients will be evaluated in a similar way
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Pascal Dynamic Contour Tonometer is an ocular device that is able to safely measure the intraocular pressure and the ocular pulse amplitude
Other Names:
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 Names:
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 Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
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One month for each patient
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Ehud Rechtman, MD, Sheba Medical Center
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Eye Diseases
- Retinal Degeneration
- Retinal Diseases
- Macular Degeneration
- Wet Macular Degeneration
- Physiological Effects of Drugs
- Antineoplastic Agents
- Antineoplastic Agents, Immunological
- Angiogenesis Inhibitors
- Angiogenesis Modulating Agents
- Growth Substances
- Growth Inhibitors
- Ranibizumab
- Bevacizumab
Other Study ID Numbers
- SHEBA-07-4739-ER-CTIL
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Neovascular Age Related Macular Degeneration
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Novartis PharmaceuticalsCompletedNeovascular Age-Related Macular DegenerationChina
-
Hoffmann-La RocheWithdrawnNeovascular Age-Related Macular DegenerationDenmark, Argentina, Hong Kong, Thailand, Portugal, Greece, Spain
-
Novartis PharmaceuticalsCompletedNeovascular Age-Related Macular DegenerationSpain, Italy, Germany, Canada, Ireland
-
Novartis PharmaceuticalsTerminatedNeovascular Age-Related Macular Degeneration
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Regeneron PharmaceuticalsCompletedNeovascular Age Related Macular DegenerationUnited States
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Hoffmann-La RocheRecruitingNeovascular Age Related Macular Degeneration | nAMDChina
-
Innostellar Biotherapeutics Co.,LtdRecruitingNeovascular Age-Related Macular DegenerationChina
-
Hoffmann-La RocheRecruitingNeovascular Age-Related Macular DegenerationBelgium, United States, United Kingdom, Italy, Argentina, Spain, Israel, Australia, Austria, Brazil, Germany, Switzerland, Taiwan, France
-
Hoffmann-La RocheCompletedNeovascular Age-Related Macular DegenerationUnited States
-
Novartis PharmaceuticalsCompletedNeovascular Age Related Macular DegenerationUnited States
Clinical Trials on Pascal Dynamic Contour Tonometer
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Sheba Medical CenterUnknown
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Yale UniversityWithdrawnIntraocular PressureUnited States
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University of CatanzaroCompletedIntraocular Pressure | Central Corneal ThicknessItaly
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University of ZurichUnknown