Study the effectiveness of the treatment detachment of retinal pigment epithelium secondary to polypoidal choroidal vasculopathy. Efficacy will be assessed by regression of polyp area after twelve months, compared to baseline. Treatment under study is a triple therapy with: 1) reduced-fluence photodynamic therapy (PDT), 2) intravitreal (IVT) triamcinolone and, 3) IVT ranibizumab, for the treatment of detachment of the retinal pigment epithelium (PED) secondary to Polypoidal Choroidal Vasculopathy (PCV).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
The treatment (single group) will be treated with reduced-fluence Photodynamic Therapy (Visudyne -Verteporfin infused over 10 minutes at a dose of 6mg/m2 and following by activating light \[wavelength of 689 nm\] applied 15 minutes after the start of infusion with a light dose of either 25 J/cm2 for 83 seconds), followed by an Intra-vitreous triamcinolone (4mg/0.1ml) on the same day. After 10 days, patients will be subjected to an injection of Intra-vitreous ranibizumab (0.5 mg/0.05 ml). After this first injection, Intra-vitreous ranibizumab will be repeated twice, on a monthly basis, for a total of three injections
Universidade Federal de São Paulo - Escola Paulista de Medicina
São Paulo, São Paulo, Brazil
Auxiliary Exams - Optical Coherency Tomography (OCT)
Optical Coherency Tomography (OCT): To Assess the Retinal Thickness using the ETDRS thickness profile and to evaluate the regression of the pigment epithelium detachment. The Auxiliary exams are done at the Baseline, 10 days after the procedure and every 30 days until the end of the study.
Time frame: 12 months after first procedure
Auxiliary Exams - Indocyanine green angiography (ICGA)
Indocyanine green angiography (ICGA): To Evaluate the polyp lesions regression The Auxiliary exams are done at the Baseline, 10 days after the procedure and every 30 days until the end of the study.
Time frame: 12 months after first procedure
Auxiliary Exams - Fluorescein Angiography (FA)
Fluorescein Angiography (FA): To Evaluate subretinal neovascularization The Auxiliary exams are done at the Baseline, 10 days after the procedure and every 30 days until the end of the study.
Time frame: 12 months after first procedure
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