CTRI/2023/09/057655招募中3 期
A Phase III, Randomized, Double blind, Parallel Group, Multicenter Study to Compare the Efficacy, Safety and Immunogenicity between Test Aflibercept and Eylea® in Patients with Neovascular (Wet) Age-Related Macular Degeneration (AMD) - NI
试验速览
- 阶段
- 3 期
- 状态
- 招募中
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. Male or female participants aged 50 years (completed) or more at the time of screening
- •2. Newly diagnosed, angiographically documented patients with primary or recurrent, active subfoveal (including juxtafoveal) choroid neovascularization (CNV) lesion secondary to neovascular (wet) age related macular degeneration (AMD) in the study eye at Screening.
- •3. The area of CNV (classic plus occult component) must be =50% of the total lesion area in the study eye
- •4. Total lesion area <12 Disc Areas (DA) in size (including blood, scars and neovascularization) as assessed by FA in the study eye
- •5. BCVA between 20/40 and 20/320 (Snellen equivalent) using Early Treatment Diabetic Retinopathy Study chart (ETDRS) testing in the study eye at Screening and Baseline
- •6. Sufficiently clear ocular media and adequate pupillary dilation should be ensured in the patient to permit good quality ocular imaging
- •7. Participants must have signed and dated an IRB/IEC approved written informed consent form in accordance with regulatory and institutional guidelines. This must be obtained before the performance of any protocol related procedures that are not part of normal patient care (If the Participant is legal blind or illiterate, an impartial witness should be present during the entire informed consent discussion)
- •8. Participants must be willing and able to comply with scheduled visits, treatment schedule, laboratory tests and other requirements of the study.
排除标准
- •1. Central subfield of the study eye affected by fibrosis or geographic atrophy assessed by color fundus photography at Screening
- •2. Total area of subfoveal fibrosis, atrophy or scarring =50% of the total lesion area in the study eye at Screening
- •3. Subretinal hemorrhage that is either 50% or more of the total lesion area, or if the blood is under the fovea and is 1 or more disc areas in size in the study eye
- •4. Any active intraocular inflammation (grade trace or above) in the study eye within 4 weeks prior to Baseline.
- •5.Known hypersensitivity to aflibercept or any of the components of study medication or Eylea® or to drugs of similar chemical class or to fluorescein or any other component of fluorescein formulation or to topical anesthetics, mydriatic medications. The patient should not be hypersensitive to any of the drugs, components of the drugs, or essential supportive drugs that are required to be used during treatment or evaluation
- •6. Any concomitant or prior treatment with ethambutol (2 weeks prior to randomization); deferoxamine and topiramate (4 weeks prior to randomization); tamoxifen, hydroxychloroquine, chloroquine, or vigabatrin (8 weeks prior to randomization), and amiodarone (12 weeks prior to randomization)
- •7. Received an investigational intervention (including investigational vaccines) or used an invasive investigational medical device within 30 days or 5 half-lives prior to Baseline, whichever is longer or is currently enrolled in an investigational study
- •8. History of drug or alcohol abuse according to Diagnostic and Statistical Manual of Mental Disorders (5th edition) (DSM-V) criteria within 1 year before Screening or positive test result(s) for alcohol or drugs of abuse (including barbiturates, opiates, cocaine, cannabinoids, amphetamines and benzodiazepines) at Screening if required as per medical history.
- •9.History of hepatitis B surface antigen (HBsAg) or hepatitis C antibody (anti-HCV) positive, or other clinically active liver disease, or tests positive for HBsAg or anti-HCV at Screening
- •10. History of human immunodeficiency virus (HIV) antibody positive, or tests positive for HIV at Screening.
- •11.Presence of uncontrolled systolic blood pressure >160 mmHg or uncontrolled diastolic blood pressure >100 mmHg based on the average of 3 readings taken with the patient in a resting state (Patients with controlled blood pressure ( <140/90) with stable anti-hypertensive treatment regimen will be eligible). No history of hypertensive crisis or encephalopathy
- •12. Documented medical history of thromboembolic events, stroke, cerebral infarction, or transient ischemic attacks, peripheral vascular disease, unstable angina pectoris, congestive heart failure or recent (within 6 months of screening) myocardial infarction, clinically significant cardiac diseases like New York Heart Association (NYHA) Grade II or greater, uncontrolled atrial fibrillation or any other cardiac arrhythmias
- •13. Documented medical history of bleeding disorders, including platelet disorders, acquired or hereditary coagulations disorders, and acquired or hereditary vascular disorders
- •14. Lymphoma, leukemia, or any malignancy within the past 5 years except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years; carcinoma in situ of the cervix; or malignancy, which is considered cure
研究者
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