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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.


Clinical Trial Description

n/a


Study Design

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


Related Conditions & MeSH terms


NCT number NCT00640640
Study type Interventional
Source Sheba Medical Center
Contact Ehud Rechtman, MD
Phone 972-52-2528871
Email ehudrechtman@gmail.com
Status Recruiting
Phase N/A
Start date August 2007
Completion date February 2009

See also
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Completed NCT00383370 - Safety and Tolerability of Intravitreal VEGF Trap Formulations in Subjects With Neovacular AMD Phase 1
Completed NCT01678963 - Efficacy and Safety of Squalamine Lactate Eye Drops in Subjects With Neovascular (Wet) Age-related Macular Degeneration (AMD) Phase 2
Completed NCT03930641 - Study of the Safety of Brolucizumab 6 mg in Prefilled Syringe in Patients With Neovascular Age Related Macular Degeneration Phase 3
Completed NCT01863199 - Impact of Home Monitoring to Decrease the Treatment Burden for Neovascular Age-related Macular Degeneration (AMD) Phase 4
Recruiting NCT05562947 - A Study Of The Efficacy, Safety, And Pharmacokinetics Of The Port Delivery System With Ranibizumab In Chinese Patients With Neovascular Age-Related Macular Degeneration Phase 3
Completed NCT04239027 - A Study to Assess the Effects of Brolucizumab in Adult Patients With Neovascular Age Related Macular Degeneration Phase 3
Completed NCT00574093 - Efficacy and Safety Study of Lucentis (Ranibizumab) and Visudyne (Verteporfin) Combination Therapy in Neovascular AMD Phase 2
Completed NCT00685100 - Retinal Effects After Combined Photodynamic Therapy (PDT) With Intravitreal Triamcinolone Phase 3
Completed NCT01942213 - Observational Study to Evaluate and Compare the Rate and Extent of Inflammation After a Single Intravitreal Injection of Ranibizumab vs. a Single Intravitreal Injection of Aflibercept in Treatment Naive and Treatment Experienced Patients. N/A