Macular oedema MedDRA version: 6.1 Level: HLGT Classification code 10047060
Conditions
Sponsors
AZIENDA OSPEDALIERA ISTITUTI OSPITALIERI DI VERONA
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria: Uncontrolled hypertension, coagulation abnormalities, renal or hepatic impairment, myocardial infarction, neoplasms, pregnant or breast-feading women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Italy
Outcome results
None listed