EUCTR2014-004579-22-DE进行中（未招募）1 期
Safety and Efficacy of Abicipar Pegol (AGN-150998) in Patients with Neovascular Age-related Macular Degeneration - CEDAR
Allergan Ltd.0 个研究点目标入组 926 人开始时间: 2015年6月12日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 926
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •General Inclusion Criteria
- •1. Male or female patients, 50 years of age or older at the time of informed consent
- •2. Patient has completed/signed an informed consent prior to conduct of any study-related
- •procedures or examinations, is able to follow study instructions, and is likely to complete
- •all required visits
- •3. Patient has provided, at screening, written documentation in accordance with the relevant
- •country and local privacy requirements (eg, Written Authorization for Use and Release of Health and Research Study Information and written Data Protection consent, as required
- •by regional health authorities)
- •Ocular Inclusion Criteria (Study Eye)
- •4. Presence of active subfoveal and/or juxtafoveal CNV (1 to 200 micron from the center) secondary to AMD assessed by fluorescein angiogram. In addition, presence of retinal fluid on optical coherence tomography (OCT) and/or fluorescein leakage under the fovea as assessed by the investigator at screening and confirmed by the central reading center prior to baseline (day 1)
- •5. Area of the CNV lesion, including both classic and occult components, must be > 50% of
- •the total lesion area as assessed by the investigator at screening and confirmed by the
- •central reading center prior to baseline (day 1)
- •6. BCVA = 73 and = 24 letters (20/40 to 20/320 Snellen equivalents, respectively) at
- •screening and at baseline (day 1, prior to treatment) visits
- •7. Sufficiently clear ocular media and adequate pupil dilation to permit good quality
- •photographic imaging
- •Ocular Inclusion Criteria (Non-study Eye)
- •8. BCVA of 34 letters (Snellen equivalent 20/200) or better at baseline (day 1), prior to treatment
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 308
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 618
排除标准
- •General Exclusion Criteria
- •1. Females who are pregnant, nursing, planning a pregnancy during the study, or who are of childbearing potential and not using a reliable method of contraception and/or not willing to use a reliable method of contraception during their participation in the study. A pregnancy test administered to women of childbearing potential at the baseline visit (day 1, prior to treatment) must be negative for the patient to receive study medication
- •2. History or current evidence of hypersensitivity to any components of the study medication or clinically relevant sensitivity to fluorescein, as assessed by the investigator at screening
- •3. History or current evidence of hypersensitivity, allergy, or anaphylactic reaction to povidone iodine solution
- •as assessed by the investigator at screening
- •4. Participation in any investigational device study within 30 days, or participation in any investigational drug study within 30 days or 5 half-lives of the respective investigational drug (whichever is longer) prior to baseline (day 1)
- •5. History or current evidence of a medical condition (including physical examination finding, or clinical laboratory finding) that may, in the opinion of the investigator, preclude the safe administration of study medication, adherence to the scheduled study visits, safe participation in the study or confound study results (eg, metabolic dysfunction, uncontrolled hypertension, autoimmune disease, infection, inflammatory condition, advanced coronary artery disease, cerebral vascular disease, other unstable or progressive cardiovascular or pulmonary condition, Parkinson's disease, liver or renal failure, cancer, or dementia)
- •6. Treatment with systemic anti-VEGF medication (eg, bevacizumab, ziv-aflibercept) or VEGF-receptor inhibitor (eg, sunitinib, sorafenib, pazopanib) within 3 months prior to baseline (day 1)
- •7. Use of systemic (eg, oral, intravenous, intramuscular, rectal), or extensive dermal (> 20% total body surface area) corticosteroids within 5 days prior to baseline (day 1)
- •Ocular Exclusion Criteria (Either Eye)
- •8. Active periocular, ocular or intraocular infection at baseline (day 1)
- •9. History of recurrent or currently active ocular or intraocular inflammation (eg, uveitis) at baseline (day 1)
- •10. History or clinical evidence of diabetic retinopathy, diabetic macular edema (DME) or any retinal vascular disease other than AMD at screening
- •Ocular Exclusion Criteria (Study Eye)
- •11. Presence of CNV other than AMD at screening, eg, pathologic myopia, ocular histoplasmosis, and angioid streaks
- •12. Spherical equivalent of the refractive error of -8 diopters of myopia or worse (prior to cataract or refractive surgery) at screening
- •13. Any active iris neovascularization, or current evidence of vitreous hemorrhage, or retinal detachment (considered by the investigator to significantly affect central vision) prior to baseline (day 1)
- •14. Previous use of verteporfin PDT or any ocular anti-angiogenic therapy (eg, aflibercept, bevacizumab, ranibizumab, pegaptanib), approved or investigational, for the treatment of neovascular AMD or previous therapeutic radiation in the r
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