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

Overview

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.

Full Title of Study: “The Effect of Intravitreal Bevacizumab & Ranibizumab on Ocular Pulse Amplitude in Neovascular Age Related Macular Degeneration”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 2008

Interventions

  • 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

Arms, Groups and Cohorts

  • Experimental: A
    • All study patients will be evaluated in a similar way

Clinical Trial Outcome Measures

Primary Measures

  • 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

Participating in This Clinical Trial

Inclusion Criteria

1. Male or female in the ages of 50 year or older 2. Willing and able to sign an inform consent Exclusion Criteria:

1. Any history, signs or symptoms of any retinal or optic nerve disease, except AMD and mild hypertensive retinopathy 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

Gender Eligibility: All

Minimum Age: 50 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Sheba Medical Center
  • Collaborator
    • Universitaire Ziekenhuizen Leuven
  • Provider of Information About this Clinical Study
    • Ehud Rechtman MD, Goldschleger Eye Institute, Sheba Medical Center
  • Overall Official(s)
    • Ehud Rechtman, MD, Principal Investigator, Sheba Medical Center
  • Overall Contact(s)
    • Ehud Rechtman, MD, 972-52-2528871, ehudrechtman@gmail.com

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