Evaluation of efficacy and safety of Intravitreal bevacizumab versus intravitreal bevacizumab combined with juxtascleral anecortave acetate for the treatment exudative age-related macular degeneration - IVB JSA

Conditions: Exudative age-related macular degeneration
MedDRA version: 9.1Level: LLTClassification code 10061763Term: Chorioretinal disorder

Registration Number: EUCTR2006-003170-99-IT

Lead Sponsor: IVERSITA DEGLI STUDI DI UDINE

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

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

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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures