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Triple Treatment for Detachment of Retinal Pigment Epithelium Secondary to Polypoidal Choroidal Vasculopathy.
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).
Details
| Lead sponsor | Federal University of São Paulo |
|---|---|
| Phase | Phase 4 |
| Status | WITHDRAWN |
| Start date | 2012-09 |
| Completion | 2014-09 |
Conditions
- Choroidal Neovascularization
- Retinal Pigment Epithelial Detachment
Interventions
- Triple Therapy
Primary outcomes
- Auxiliary Exams - Optical Coherency Tomography (OCT) — 12 months after first procedure
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. - Auxiliary Exams - Indocyanine green angiography (ICGA) — 12 months after first procedure
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. - Auxiliary Exams - Fluorescein Angiography (FA) — 12 months after first procedure
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.
Countries
Brazil