Evaluation of Safety and Efficacy on Visual Acuity Outcome and Choroidal Neovascularization of Intravitreal Somministration of Bevacizumab Avastin, Roche, United Kingdom in patients with Subfoveal Choroidal Neovascularization due to Age Related Macular Degeneration - ND

• Conditions: Subfoveal Choroidal Neovascularization due to Age Related Macular Degeneration who did not respond to currently available treatments; MedDRA version: 6.1Level: PTClassification code 10060823

• Registration Number: EUCTR2006-002424-42-IT
• Lead Sponsor: OSPEDALE SACRO CUORE-DON CALABRIA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-06-05
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

1.Patients with subfoveal CNV due to ARMD who did not respond to currently available treatments presenting enlargment of CNV, and or reduced VA 2. 1 50 VA 4 10 3. Patients with bilateral disease will receive the treatment only in one eye in order to evaluate the risks benefits. Only in case of benefit, the second eye will be treated.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Poor Blood Pressure control 2.Previous Thromboembolic events, myocardial infarction, cerebral stroke. 3.Pregnant women, or fertile age women who do not take the contraceptive pills 4.Breast feeding women

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Evaluation of safety of intravitreal somministration of Bevacizumab Avastin, Roche, United Kingdom .;Secondary Objective: To evaluate the efficacy of intravitreal somministration of Bevacizumab in patients with subfoveal choroidal neovascularization CNV due to Age Related Macular Degeneration ARMD who present visual loss after having received all other currently available treatments. The efficacy will be determined by two parameters 1. Maintainence of stable visual acuity VA ; 2. Reduced CNV activity on fluorescein angiography and OCT.;Primary end point(s): Evaluation of safety of intravitreal somministration of Bevacizumab Avastin, Roche, United Kingdom .