Subfoveal Choroidal Neovascularization due to Age Related Macular Degeneration who did not respond to currently available treatments MedDRA version: 6.1 Level: PT Classification code 10060823
Conditions
Sponsors
OSPEDALE SACRO CUORE-DON CALABRIA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Patients with subfoveal CNV due to ARMD who did not respond to currently available treatments presenting enlargment of CNV, and or reduced VA 2. 1 50 VA 4 10 3. Patients with bilateral disease will receive the treatment only in one eye in order to evaluate the risks benefits. Only in case of benefit, the second eye will be treated. 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: 1.Poor Blood Pressure control 2.Previous Thromboembolic events, myocardial infarction, cerebral stroke. 3.Pregnant women, or fertile age women who do not take the contraceptive pills 4.Breast feeding women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evaluation of safety of intravitreal somministration of Bevacizumab Avastin, Roche, United Kingdom .;Secondary Objective: To evaluate the efficacy of intravitreal somministration of Bevacizumab in patients with subfoveal choroidal neovascularization CNV due to Age Related Macular Degeneration ARMD who present visual loss after having received all other currently available treatments. The efficacy will be determined by two parameters 1. Maintainence of stable visual acuity VA ; 2. Reduced CNV activity on fluorescein angiography and OCT.;Primary end point(s): Evaluation of safety of intravitreal somministration of Bevacizumab Avastin, Roche, United Kingdom . | — |
Countries
Italy
Outcome results
None listed