Phase III clinical trial multicenter randomized for the evaluation of the safety and efficacy of the combined treatment of intravitreal triamcinolone and photodynamic therapy versus intravitreal Bevacizumab and photodynamic therapy versus intravitreal Bevacizumab for the treatment of neo-vascular maculopathy type retinal angiomatous prolipheration (RAP). - ND
- Conditions
- Choroideal neo-vascularization type RAP.MedDRA version: 9.1Level: SOCClassification code 10015919
- Registration Number
- EUCTR2008-001468-34-IT
- Lead Sponsor
- AZIENDA OSPEDALIERA L. SACCO (A.O. DI RILIEVO NAZIONALE)
- 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
Signed informed consent.
Age > 50 year.
RAP stage II and III.
BCVA with ETDRS between 20/40 and 20/320.
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
Decompensated blood hypertension.
Thromboembolic events within 6 months, including TIA, cerebral stroke, and myocardial infarction.
Impossibility to document the lesion via FA, ICG, angiography, color photos of fundus oculi,OCT.
Any other condition that could compromize visual acuity.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Secondary Objective: None.;Primary end point(s): Stabilization of the lesion size.;Main Objective: To evaluate the effectiveness of the combined treatment of intravitreal triamcinolone and photodynamic therapy versus intravitreal Bevacizumab and photodynamic therapy versus intravitreal Bevacizumab in the treatment of RAP.
- Secondary Outcome Measures
Name Time Method