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

Neovascular Age Related Macular Degeneration Clinical Trial

— AMD  

Official title:

The Effect of Intravitreal Bevacizumab & Ranibizumab on Ocular Pulse Amplitude in Neovascular Age Related Macular Degeneration

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00640640
• Other study ID #: SHEBA-07-4739-ER-CTIL
• Status: Recruiting
• Phase: N/A
• First received: February 24, 2008
• Last updated: March 20, 2008
• Start date: August 2007
• Est. completion date: February 2009

Study information

• Verified date: March 2008
• Source: Sheba Medical Center
• Contact: Ehud Rechtman, MD
• Phone: 972-52-2528871
• Email: ehudrechtman[@]gmail.com
• Is FDA regulated: No
• Health authority: Israel: Israeli Health Ministry Pharmaceutical Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: February 2009
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Macular Degeneration
• Neovascular Age Related Macular Degeneration
• Wet Macular Degeneration

Intervention

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
• 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

Locations

Country	Name	City	State
Belgium	University Hospitals Leuven	Leuven
Israel	Goldschleger Eye Institute Sheba Medical Center	Ramat Gan

Sponsors (2)

Lead Sponsor	Collaborator
Sheba Medical Center	Universitaire Ziekenhuizen Leuven

Countries where clinical trial is conducted

Belgium,  Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes