Diabetic Retinopathy MedDRA version: 8.1 Level: LLT Classification code 10012689 Term: Diabetic retinopathy
Conditions
Interventions
Trade Name: AVASTIN
Pharmaceutical Form: Concentrate for solution for infusion
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 1250-
Sponsors
OSPEDALE SACRO CUORE-DON CALABRIA
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Italy
Outcome results
None listed