Evaluation of safety and efficacy on visual acuity outcome of intravitreal somministration of Bevacizumab in patients with diabetic retinopathy - ND

• Conditions: Diabetic Retinopathy; MedDRA version: 8.1Level: LLTClassification code 10012689Term: Diabetic retinopathy

• Registration Number: EUCTR2006-005315-10-IT
• Lead Sponsor: OSPEDALE SACRO CUORE-DON CALABRIA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-11-10
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

a Patients with macular edema who did not respond to laser treatment or with visual acuity 2/10 b Patients with severe diabetic retinal proliferation
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

a Poor Blood Pressure control. b Previus Thromboembolic events, myocardial infarction, cerebral stroke. c Pregnant women, or fertile age women who do not take contraceptive pills. d 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 administration of Bevacizumab.;Secondary Objective: To evaluate the efficacy, determined by maintainence of stable visual acuity and reduction of macular edema and neovascular proliferations, in patients with diabetic retinopathy who present visual loss after having received all other currently available treatments.;Primary end point(s): Evaluation of safety of intravitreal somministration of Bevacizumab.