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| Name | Class |
|---|---|
| European Vision Institute Clinical Research Network | NETWORK |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aflibercept Monotherapy | Sham Comparator | IVT Aflibercept 2 mg + Sham PDT |
|
| Aflibercept + verteporfin PDT | Active Comparator | IVT Aflibercept 2 mg + Verteporfin PDT |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intravitreal Aflibercept | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Best Corrected Visual Acuity (BCVA) | Unit of Measure: [Letters] | from Baseline (Week 0) to Week 52. |
| Polyps regression | Unit of Measure: [Yes, No] | from Baseline (W0) to Week 52. |
| Measure | Description | Time Frame |
|---|---|---|
| Polyps regression, assessed by Indocyanine Green Angiography (ICGA); | Unit of Measure: [Yes, No] | from Baseline (W0) to Week 16 |
| Presence of active polyps, assessed by Indocyanine Green Angiography (ICGA); |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rufino Silva, PhD | Association for Innovation and Biomedical Research on Light and Image | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital de Braga | Braga | 4710-243 | Portugal | |||
| AIBILI - Centro de Ensaios Clínicos |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34348351 | Derived | Silva R, Arias L, Nunes S, Farinha C, Coimbra R, Marques JP, Cachulo ML, Figueira J, Barreto P, Madeira MH, Pires I, Sousa JC, Distefano L, Rosa P, Carneiro A, Vaz-Pereira S, Meireles A, Cabrera F, Bures A, Mendonca L, Fernandez-Vega-Sanz A, Barrao S, Koh A, Cheung CMG, Cunha-Vaz JG, Murta J; EVICR.net ATLANTIC Study Group. Efficacy and Safety of Intravitreal Aflibercept Treat and Extend for Polypoidal Choroidal Vasculopathy in the ATLANTIC Study: A Randomized Clinical Trial. Ophthalmologica. 2022;245(1):80-90. doi: 10.1159/000518235. Epub 2021 Jul 13. | |
| 28851779 |
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Unit of Measure: [Yes, No]
| from Baseline (W0) to Week 52 |
| Presence of leakage based on fluorescein angiography (FA) | Unit of Measure: [Yes, No] | 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] | 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] | from Baseline (W0) to Week 52 |
| Total number of treatments with Aflibercept; | Unit of Measure: [#] | from Baseline (W0) to Week 52 |
| Frequency and severity of ocular and non-ocular adverse events over time. | Unit of Measure: [Mild, Moderate, Severe] | from Baseline (W0) to Week 52 |
| Coimbra |
| 3000-548 Coimbra |
| Portugal |
| Espaço Médico de Coimbra | Coimbra | 3030-163 | Portugal |
| Centro Hospitalar de Leiria | Leiria | 2400-171 | Portugal |
| IRL - Instituto de Retina e Diabetes de Lisboa | Lisbon | 1050-085 Lisboa | Portugal |
| Centro Hospitgalar de Lisboa Norte, EPE - Hospital de Santa Maria | Lisbon | 1649-035 | Portugal |
| Instituto de Oftalmologia Dr. Gama Pinto | Lisbon | Portugal |
| Centro Hospitalar do Porto- Hospital de Santo António | Porto | 4099-001 | Portugal |
| Centro Hospitalar de São João, EPE - Serviço de Oftalmologia | Porto | 4200-319 | Portugal |
| Bellvitge University Hospital | Barcelona | Spain |
| Instituto de Microcirugia Ocular | Barcelona | Spain |
| Vall d'Hebron Hospital | Barcelona | Spain |
| Hospital Insular de Gran Canaria | Las Palmas | Spain |
| Derived |
| Marques JP, Farinha C, Costa MA, Ferrao A, Nunes S, Silva R. Protocol for a randomised, double-masked, sham-controlled phase 4 study on the efficacy, safety and tolerability of intravitreal aflibercept monotherapy compared with aflibercept with adjunctive photodynamic therapy in polypoidal choroidal vasculopathy: the ATLANTIC study. BMJ Open. 2017 Aug 28;7(8):e015785. doi: 10.1136/bmjopen-2016-015785. |
| ID | Term |
|---|---|
| D000092342 | Polypoidal Choroidal Vasculopathy |
| ID | Term |
|---|---|
| D020256 | Choroidal Neovascularization |
| D015862 | Choroid Diseases |
| D014603 | Uveal Diseases |
| D005128 | Eye Diseases |
| D009389 | Neovascularization, Pathologic |
| D008679 | Metaplasia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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