Exudative age-related macular degeneration MedDRA version: 9.1 Level: LLT Classification code 10061763 Term: Chorioretinal disorder
Conditions
Sponsors
UNIVERSITA DEGLI STUDI DI UDINE
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients who are 50 year old or older. Patients willing to sign a written informed consent. Patients with age-related macular degeneration and subfoveal choroidal neovascularization, primary when the lesion characteristics controindicate standard treatments, i.e. large occult neovascularization, greater than 4 disc areas or recurrent after standard treatment increase of lesione size by 10 and/or visual loss equal or greater than 2 ETDRS lines after photodynamic therapy with verteporfin 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: Concomitant ocular disease in the study eye that could affect visual acuity Prior treatment of the study eye with photodinamic therapy, laser photocoagulation within 90 days preceeding day 1 or any other experimental treatmentPrior ocular surgery within 60 days preceeding baseline Uncontrolled blood pressure Previous stroke or myocardial infarction
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine whether intravitreal bevacizumab combined with juxtascleral anecortave acetate provides greater benefit, with an acceptable safety profile, compared to intravitreal bevacizumab alone;Secondary Objective: Evaluate the efficacy of combined therapy bevacizumab anecortave acetate versus bevacizumab alone on the mean variation of best corrected visual acuity assessed with ETDRS charts;Primary end point(s): To compare the efficacy of 2 different treatment regimens intravitreal bevacizumab alone and intravitreal bevacizumab combined with juxtascleral anecortave acetate assessed by the number or retreatments with intravitreal bevacizumab needed after a single injection of bevacizumab at 12 months, compared with predefined retreatment criteria monthly intravitreal bevacizumab | — |
Countries
Italy
Outcome results
None listed