Evaluation of safety and efficacy of intravitreal bevacizumab for macular edema, retinal or choroidal neovascularization or neovascular glaucoma - ND
- Conditions
- Macular oedemaMedDRA version: 6.1Level: HLGTClassification code 10047060
- Registration Number
- EUCTR2006-002351-33-IT
- Lead Sponsor
- AZIENDA OSPEDALIERA ISTITUTI OSPITALIERI DI VERONA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
Patients with vascular diseases of the eye, complicated by essudative maculopathy refractory to previous treatment or in which standard therapy is contraindicated or so severe that a favorable response is unpredictable.
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
Uncontrolled hypertension, coagulation abnormalities, renal or hepatic impairment, myocardial infarction, neoplasms, pregnant or breast-feading women
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate the efficacy of intravitreal bavacizumab on visual acuity and on retinal structure in patients with essudative macular diseases;Secondary Objective: To assess the safety of bevacizumab through the evaluation of ocular or systemic adverse events;Primary end point(s): Rates of patients that gain or loss 5, 15 or 30 letters.
- Secondary Outcome Measures
Name Time Method