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

Not Applicable

• Conditions: Neovascular Age Related Macular Degeneration
• Interventions: Device: Pascal Dynamic Contour Tonometer; Drug: Ranibizumab; Drug: Bevacizumab

• Registration Number: NCT00640640
• Lead Sponsor: Sheba Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-08
• Study First Submitted: 2008-02-24
• Status Verified: 2008-03
• Study First Submitted QC: 2008-03-20
• Last Update Submitted: 2008-03-20
• Study First Posted: 2008-03-21
• Last Update Posted: 2008-03-21
• Primary Completion: 2008-12
• Study Completion: 2009-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
A	Pascal Dynamic Contour Tonometer	All study patients will be evaluated in a similar way
A	Bevacizumab	All study patients will be evaluated in a similar way
A	Ranibizumab	All study patients will be evaluated in a similar way

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

University Hospitals Leuven; 🇧🇪 Leuven, Belgium

Goldschleger Eye Institute Sheba Medical Center; 🇮🇱 Ramat Gan, Israel