The purpose of this study is to compare the efficacy and safety of intravitreal Aflibercept monotherapy with the efficacy and safety of combined treatment with Aflibercept plus standard photodynamic therapy (PDT) with Verteporfin in age-related macular degeneration (AMD) patients with polypoidal choroidal vasculopathy (PCV).
To compare the efficacy and safety of intravitreal Aflibercept monotherapy with the efficacy and safety of combined treatment with Aflibercept associated with standard photodynamic therapy (PDT) with Verteporfin in age-related macular degeneration (AMD) patients with polypoidal choroidal vasculopathy (PCV) in a proof concept study and to identify genetic biomarkers for the diagnosis and treatment response of PCV in Caucasians.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
50
Hospital de Braga
Braga, Portugal
AIBILI - Centro de Ensaios Clínicos
Coimbra, Portugal
Espaço Médico de Coimbra
Coimbra, Portugal
Centro Hospitalar de Leiria
Leiria, Portugal
IRL - Instituto de Retina e Diabetes de Lisboa
Lisbon, Portugal
Centro Hospitgalar de Lisboa Norte, EPE - Hospital de Santa Maria
Lisbon, Portugal
Instituto de Oftalmologia Dr. Gama Pinto
Lisbon, Portugal
Centro Hospitalar do Porto- Hospital de Santo António
Porto, Portugal
Centro Hospitalar de São João, EPE - Serviço de Oftalmologia
Porto, Portugal
Bellvitge University Hospital
Barcelona, Spain
...and 3 more locations
Change in Best Corrected Visual Acuity (BCVA)
Unit of Measure: \[Letters\]
Time frame: from Baseline (Week 0) to Week 52.
Polyps regression
Unit of Measure: \[Yes, No\]
Time frame: from Baseline (W0) to Week 52.
Polyps regression, assessed by Indocyanine Green Angiography (ICGA);
Unit of Measure: \[Yes, No\]
Time frame: from Baseline (W0) to Week 16
Presence of active polyps, assessed by Indocyanine Green Angiography (ICGA);
Unit of Measure: \[Yes, No\]
Time frame: from Baseline (W0) to Week 52
Presence of leakage based on fluorescein angiography (FA)
Unit of Measure: \[Yes, No\]
Time frame: from Baseline (W0) to Week 52
Change in the Subfield Central Retinal Thickness (CRT), assessed by Spectral Domain-Optical Coherence Tomography (SD-OCT);
Unit of Measure: \[µm\]
Time frame: from Baseline (W0) to Week 52
Presence of fluid assessed on Spectral Domain-Optical Coherence Tomography (SD-OCT) at Week 52;
Unit of Measure: \[Yes, No\]
Time frame: from Baseline (W0) to Week 52
Total number of treatments with Aflibercept;
Unit of Measure: \[#\]
Time frame: from Baseline (W0) to Week 52
Frequency and severity of ocular and non-ocular adverse events over time.
Unit of Measure: \[Mild, Moderate, Severe\]
Time frame: from Baseline (W0) to Week 52
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