Exudative age-related macular degeneration MedDRA version: 12.1 Level: LLT Classification code 10015902 Term: Exudative senile macular degeneration of retina
Conditions
Interventions
Trade Name: AVASTIN
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Bevacizumab
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1.25-
Sponsors
U.L.S.S. 16
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients affected by exudative age-related macular degeneration, patients with age ≥50 years, type of choroidal neovascularization (CNV), classic, minimally classic and occult CNV, location of CNV: subfoveal, juxtafoveal and extrafoveal, size of CNV ≤ 5.4 mm (9 DD), leakage on fluorescein angiography ≥ 50% of the entire CNV area, subretinal fibrosis ≤ 50% CNV area, OCT thickness ≤ 450 ?m, best-corrected visual acuity between 20/100 and 20/320, previous treatment with anti-VEGF, PDT, laser and others, onset of symptom ≤ 30 days before treatment, presence of hemorrhage ≤ 70% of the entire CNV area, CNV associated with serious pigment epithelium detachment, patient with retinal angiomatous 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: Visual acuity ≥ 20/100, neovascular lesion associated with chorioretina-retinal folds, chorioretinal atrophy, tear of retinal pigment epithelium, uncontrolled blood pressure, opacities of the clear refractive media of the eye such as the cornea, anterior chamber, lens and vitreous, abnormalities of coagulation, renal failure, thromboembolic events, stroke, TIA, arrhythmia 6 months before the study start, general surgery planned 3 months the study start, general surgery 2 months before the study start, pregnant woman. women on breast-feeding.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of intravitreal bevacizumab to stabilize/improve visual acuity in patients with lower visual acuity (<20/100) or not elegible for treatment with ranibizumab and pegaptanib.;Secondary Objective: 1. To obtain a stabilization/improvement of the angiographic and anatomic features in patients with coroidal neovascularization by means of fluorescein/ICG angiography and OCT respectively. 2. to analyze if bevacizumab may induce positive effects in the ``vision-related quality of life`` (QoL score).;Primary end point(s): % of responders (stable or improved) after 12 months treatment. | — |
Countries
Italy
Outcome results
None listed