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Intravitreal Bevacizumab Avastin, Roche, United Kingdom for exudative maculopathies - Intravitreal bevacizumab

Conditions
Exudative maculopathy associated with retinovascular disease
MedDRA version: 6.1Level: PTClassification code 10012689
Registration Number
EUCTR2005-006182-14-IT
Lead Sponsor
IVERSITA DEGLI STUDI DI UDINE
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Authorised-recruitment may be ongoing or finished
Sex
All
Target Recruitment
30
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

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

Study & Design

Study Type
Interventional clinical trial of medicinal product
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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