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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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
Sponsor:
Collaborator:
Information provided by:

February 24, 2008
March 21, 2008
March 21, 2008
August 2007
December 2008   (Final data collection date for primary outcome measure)
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 ]
Same as current
No Changes Posted
Not Provided
Not Provided
Not Provided
Not Provided
 
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

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.

Not Provided
Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Neovascular Age Related Macular Degeneration
  • 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
  • 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
    Other Name: Lucentis
  • 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
    Other Name: Avastin
Experimental: A
All study patients will be evaluated in a similar way
Interventions:
  • Device: Pascal Dynamic Contour Tonometer
  • Drug: Ranibizumab
  • Drug: Bevacizumab
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
60
February 2009
December 2008   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
50 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Belgium,   Israel
 
 
NCT00640640
SHEBA-07-4739-ER-CTIL
No
Not Provided
Not Provided
Ehud Rechtman MD, Goldschleger Eye Institute, Sheba Medical Center
Sheba Medical Center
Universitaire Ziekenhuizen Leuven
Principal Investigator: Ehud Rechtman, MD Sheba Medical Center
Sheba Medical Center
March 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP