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

NCT00640640 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2008-03-21

No results posted yet for this study

Summary

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.

Conditions

  • Neovascular Age Related Macular Degeneration

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

Sponsors & Collaborators

  • Universitaire Ziekenhuizen KU Leuven

    collaborator OTHER

  • Sheba Medical Center

    lead OTHER_GOV

Principal Investigators

  • Ehud Rechtman, MD · Sheba Medical Center

Study Design

Allocation
NA
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-08-31
Primary Completion
2008-12-31
Completion
2009-02-28

Countries

  • Belgium
  • Israel

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00640640 on ClinicalTrials.gov