{
    "info": {
        "nct_id": "NCT03211741",
        "official_title": "Longterm Efficiency and Safety of Intravitreal Injections With Bevacizumab in Patients With Neovascularisation or Macular Edema",
        "inclusion_criteria": "1. Age ≥ 18 years of either gender\n2. Written informed consent must be obtained before any intravitreal injection of bevacizumab is performed\n3. Visual impairment predominantly due to abnormal new vessel ingrowth and/or macular edema. The presence of fluid (intraretinal, subretinal or sub-RPE) detected clinically or on the ocular coherence tomography.\n\nIf both eyes are eligible for the study, both eyes can be included in the study.\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "1. Women who are pregnant or breastfeeding (pregnancy defined as the state of a female after conception until the termination of gestation, confirmed by a positive human chorionic gonadotropin laboratory test (> 5mIU/mL)\n2. Women of child bearing potential must be practicing effective contraception implemented during the trial and for at least 28 days following the last dose of study medication\n3. Tromboembolic event (CVA or transient ischemic attack, AMI) less than 3 months prior to the intravitreal injection of bevacizumab\n4. History of hypersensitivity for bevacizumab.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "1. Age ≥ 18 years of either gender",
            "criterions": [
                {
                    "exact_snippets": [
                        "Age ≥ 18 years"
                    ],
                    "criterion": "age",
                    "requirement_type": "range",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": ">=",
                                "value": 18
                            }
                        ]
                    }
                },
                {
                    "exact_snippets": [
                        "either gender"
                    ],
                    "criterion": "gender",
                    "requirement_type": "inclusion",
                    "expected_value": [
                        "male",
                        "female"
                    ]
                }
            ]
        },
        {
            "line": "2. Written informed consent must be obtained before any intravitreal injection of bevacizumab is performed",
            "criterions": [
                {
                    "exact_snippets": [
                        "Written informed consent must be obtained"
                    ],
                    "criterion": "informed consent",
                    "requirement_type": "availability",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "before any intravitreal injection of bevacizumab is performed"
                    ],
                    "criterion": "intravitreal injection of bevacizumab",
                    "requirement_type": "timing",
                    "expected_value": "before"
                }
            ]
        },
        {
            "line": "3. Visual impairment predominantly due to abnormal new vessel ingrowth and/or macular edema. The presence of fluid (intraretinal, subretinal or sub-RPE) detected clinically or on the ocular coherence tomography.",
            "criterions": [
                {
                    "exact_snippets": [
                        "Visual impairment predominantly due to abnormal new vessel ingrowth"
                    ],
                    "criterion": "visual impairment",
                    "requirement_type": "cause",
                    "expected_value": "abnormal new vessel ingrowth"
                },
                {
                    "exact_snippets": [
                        "Visual impairment predominantly due to",
                        "macular edema"
                    ],
                    "criterion": "visual impairment",
                    "requirement_type": "cause",
                    "expected_value": "macular edema"
                },
                {
                    "exact_snippets": [
                        "The presence of fluid"
                    ],
                    "criterion": "fluid",
                    "requirement_type": "presence",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "intraretinal"
                    ],
                    "criterion": "fluid location",
                    "requirement_type": "location",
                    "expected_value": "intraretinal"
                },
                {
                    "exact_snippets": [
                        "subretinal"
                    ],
                    "criterion": "fluid location",
                    "requirement_type": "location",
                    "expected_value": "subretinal"
                },
                {
                    "exact_snippets": [
                        "sub-RPE"
                    ],
                    "criterion": "fluid location",
                    "requirement_type": "location",
                    "expected_value": "sub-RPE"
                }
            ]
        },
        {
            "line": "If both eyes are eligible for the study, both eyes can be included in the study.",
            "criterions": [
                {
                    "exact_snippets": [
                        "both eyes are eligible for the study"
                    ],
                    "criterion": "eyes",
                    "requirement_type": "eligibility",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": [
                        "Healthy volunteers allowed"
                    ],
                    "criterion": "healthy volunteers",
                    "requirement_type": "participation",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "Must have minimum age of 18 Years",
            "criterions": [
                {
                    "exact_snippets": [
                        "minimum age of 18 Years"
                    ],
                    "criterion": "age",
                    "requirement_type": "minimum",
                    "expected_value": {
                        "operator": ">=",
                        "value": 18
                    }
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "1. Women who are pregnant or breastfeeding (pregnancy defined as the state of a female after conception until the termination of gestation, confirmed by a positive human chorionic gonadotropin laboratory test (> 5mIU/mL)",
            "criterions": [
                {
                    "exact_snippets": [
                        "Women who are pregnant"
                    ],
                    "criterion": "pregnancy",
                    "requirement_type": "presence",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "breastfeeding"
                    ],
                    "criterion": "breastfeeding",
                    "requirement_type": "presence",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "positive human chorionic gonadotropin laboratory test (> 5mIU/mL)"
                    ],
                    "criterion": "human chorionic gonadotropin",
                    "requirement_type": "level",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": ">",
                                "value": 5
                            }
                        ]
                    }
                }
            ]
        },
        {
            "line": "2. Women of child bearing potential must be practicing effective contraception implemented during the trial and for at least 28 days following the last dose of study medication",
            "criterions": [
                {
                    "exact_snippets": [
                        "Women of child bearing potential"
                    ],
                    "criterion": "child bearing potential",
                    "requirement_type": "presence",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "must be practicing effective contraception"
                    ],
                    "criterion": "contraception",
                    "requirement_type": "practice",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "implemented during the trial and for at least 28 days following the last dose of study medication"
                    ],
                    "criterion": "contraception duration",
                    "requirement_type": "duration",
                    "expected_value": "during the trial and for at least 28 days following the last dose of study medication"
                }
            ]
        },
        {
            "line": "3. Tromboembolic event (CVA or transient ischemic attack, AMI) less than 3 months prior to the intravitreal injection of bevacizumab",
            "criterions": [
                {
                    "exact_snippets": [
                        "Tromboembolic event (CVA or transient ischemic attack, AMI)"
                    ],
                    "criterion": "tromboembolic event",
                    "requirement_type": "occurrence",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "less than 3 months prior to the intravitreal injection of bevacizumab"
                    ],
                    "criterion": "time since tromboembolic event",
                    "requirement_type": "duration",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": "<",
                                "value": 3
                            }
                        ]
                    }
                }
            ]
        },
        {
            "line": "4. History of hypersensitivity for bevacizumab.",
            "criterions": [
                {
                    "exact_snippets": [
                        "History of hypersensitivity for bevacizumab"
                    ],
                    "criterion": "hypersensitivity",
                    "requirement_type": "history",
                    "expected_value": "bevacizumab"
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}