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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2008 by Sheba Medical Center.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Universitaire Ziekenhuizen Leuven
Information provided by:
Sheba Medical Center
ClinicalTrials.gov Identifier:
NCT00640640
First received: February 24, 2008
Last updated: March 20, 2008
Last verified: March 2008
  Purpose

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 Intervention
Neovascular Age Related Macular Degeneration
Device: Pascal Dynamic Contour Tonometer
Drug: Ranibizumab
Drug: Bevacizumab

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: The Effect of Intravitreal Bevacizumab & Ranibizumab on Ocular Pulse Amplitude in Neovascular Age Related Macular Degeneration

Resource links provided by NLM:


Further study details as provided by Sheba Medical Center:

Primary Outcome 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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 60
Study Start Date: August 2007
Estimated Study Completion Date: February 2009
Estimated Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
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
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

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00640640

Contacts
Contact: Ehud Rechtman, MD 972-52-2528871 ehudrechtman@gmail.com

Locations
Belgium
University Hospitals Leuven Recruiting
Leuven, Belgium
Contact: Ingeborg Stalmans, MD, PhD         
Israel
Goldschleger Eye Institute Sheba Medical Center Recruiting
Ramat Gan, Israel, 52621
Contact: Ehud Rechtman, MD    972-52-2528871    ehudrechtman@gmail.com   
Principal Investigator: Ehud Rechtman, MD         
Sponsors and Collaborators
Sheba Medical Center
Universitaire Ziekenhuizen Leuven
Investigators
Principal Investigator: Ehud Rechtman, MD Sheba Medical Center
  More Information

No publications provided

Responsible Party: Ehud Rechtman MD, Goldschleger Eye Institute, Sheba Medical Center
ClinicalTrials.gov Identifier: NCT00640640     History of Changes
Other Study ID Numbers: SHEBA-07-4739-ER-CTIL
Study First Received: February 24, 2008
Last Updated: March 20, 2008
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Sheba Medical Center:
IOP
OPA
AMD
bevacizumab
ranibizumab
choroidal blood flow
DCT
Ocular Pulse Amplitude change following anti VEGF
Ocular Pulse Amplitude

Additional relevant MeSH terms:
Macular Degeneration
Wet Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Bevacizumab
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Growth Inhibitors
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 28, 2014