Choroidal neovascularization in patients with age-related macular degeneration.
Conditions
Interventions
Trade Name: AVASTIN
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Bevacizumab
Concentration unit: ml millilitre(s)
Concentration type: equal
Concentration number: .05-
Trade Name:
Sponsors
AZIENDA OSPEDALIERA L. SACCO (A.O. DI RILIEVO NAZIONALE)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - age beetween 50 and 80 - wet AMD with choroidal neovascularization - absence of: any possibile systemic causes of vasculopathy, any vascular disorders of the retina and choroid, previous intravitreal drug injections, previous eye surgery. 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: . previous eye surgery . any changes at the cornea and lens level which interfere with a good visualization of fundus. . previous intravitreal drug injections . any possibile systemic causes of periferic vasculopathy . hypersensitivity to the drug in study . women in pregnancy and breast-feeding or women who have intention of having one pregnancy in the period of time of duration of the study . prior treatment for CNV secondary to AMD in the study eye including PDT or Argon laser
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the variations of choroidal blood flow of intravitreal injection of Pan anti-VEGF (Avastin) and Selective anti-VEGF (Macugen) using dynamic ICG angiography with confocal scanning laser ophthalmoscope (HRA, Heidelberg engineering).;Secondary Objective: To evaluate the safety of both drugs and the cumulative toxic effect.;Primary end point(s): difference in choroidal blood flow between the two drugs. | — |
Countries
Italy
Outcome results
None listed