Exudative maculopathy associated with retinovascular disease MedDRA version: 6.1 Level: PT Classification code 10012689
Conditions
Interventions
Trade Name: AVASTIN INFUS 1FL 100MG
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: BEVACIZUMAB
Concentration unit: mg milligram(s)
Concentration type: equal
Concentrat
Sponsors
UNIVERSITA DEGLI STUDI DI UDINE
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Patients with diffuse clinically significant diabetic macular edema CSDME ETDRS criteria either unresponsive to prior treatments laser or intravitreal triamcinolone or combined or very severe at initial presentation - Patients with nonischemic branch retinal vein occlusion BRVO or central retinal vein occlusion CRVO and severe cystoid macular edema either unresponsive to prior treatments or persisting after 6 months since initial presentation - Patients with age-related macular degeneration AMD and subfoveal choroidal neovascularization CNV either unresponsive to prior PDT or unlikely to respond to PDT large subretinal hemorrhage, large PED, large minimally classic lesion, chorioretinal anastomosis - Patients with age-related macular degeneration AMD and stage II-III retinal angiomatous proliferation RAP 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: EYE - History of any ocular surgery within the previous 6 months - Significant media opacities - Macular ischemia at fluorescein angiography MEDICAL - Chronic liver disease, clinical jaundice, and/or elevation of liver-related laboratory results 2 times the upper limit of normal - Chronic renal failure on dialysis - Stroke - Congestive heart failure or myocardial infarction - Cancer
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: to evaluate the effectiveness of intravitreal bevacizumab on visual acuity and retinal morphology in patients with retinovascular disease;Secondary Objective: to evaluate the safety of intravitreal bevacizumab;Primary end point(s): percentage of patients with gain or loss of 5, 15 or 30 ETDRS letters | — |
Countries
Italy
Outcome results
None listed