NCT00640640

Brief 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.

Trial Health

47
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2007

Geographic Reach
2 countries

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2007

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

February 24, 2008

Completed
26 days until next milestone

First Posted

Study publicly available on registry

March 21, 2008

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2009

Completed
Last Updated

March 21, 2008

Status Verified

March 1, 2008

Enrollment Period

1.3 years

First QC Date

February 24, 2008

Last Update Submit

March 20, 2008

Conditions

Neovascular Age Related Macular Degeneration

Keywords

IOPOPAAMDbevacizumabranibizumabchoroidal blood flowDCTOcular Pulse Amplitude change following anti VEGFOcular Pulse Amplitude

Outcome Measures

Primary Outcomes (1)

  • Ocular pulse pressure (OPA)a week and month after intravitreal bevacizumab/ranibizumab, as compare to baseline OPA, just prior to treatment

    One month for each patient

Study Arms (1)

A

EXPERIMENTAL

All study patients will be evaluated in a similar way

Device: Pascal Dynamic Contour TonometerDrug: RanibizumabDrug: Bevacizumab

Interventions

Pascal Dynamic Contour TonometerDEVICE

Pascal Dynamic Contour Tonometer is an ocular device that is able to safely measure the intraocular pressure and the ocular pulse amplitude

Also known as: Pascal Dynamic Contour Tonometer = Pascal DCT
A
RanibizumabDRUG

measure the effect of intravitreal 0.5mg/0.05ml ranibizumab on the intraocular pressure and ocular pulse amplitude with the Pascal Dynamic Contour Tonometer

Also known as: Lucentis
A
BevacizumabDRUG

measure the effect of intravitreal 1.25mg/0.05ml bevacizumab on the intraocular pressure and ocular pulse amplitude with the Pascal Dynamic Contour Tonometer

Also known as: Avastin
A

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female in the ages of 50 year or older
  • Willing and able to sign an inform consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University Hospitals Leuven

Leuven, Belgium

RECRUITING

Goldschleger Eye Institute Sheba Medical Center

Ramat Gan, 52621, Israel

RECRUITING

MeSH Terms

Interventions

RanibizumabBevacizumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Ehud Rechtman, MD

    Sheba Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ehud Rechtman, MD

CONTACT

972-52-2528871ehudrechtman@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

February 24, 2008

First Posted

March 21, 2008

Study Start

August 1, 2007

Primary Completion

December 1, 2008

Study Completion

February 1, 2009

Last Updated

March 21, 2008

Record last verified: 2008-03

Locations

IL(1)BE(1)