EUCTR2014-004579-22-LV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7月9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
- 性别
- All
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 secondary to AMD with 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
- •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 iodine
- •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 ocular/intraocular infection at baseline (day 1)
- •9. History of recurrent or currently active ocular/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 region of the study eye
- •15. Any prior or current systemic or ocular treatment (including surgery) for neovascular
- •AMD, approved or investigational, except dietary supplements or vitamins
- •16. Prior use of ocular anti-VEGF agents for neovascular eye diseases other than AMD
- •17. Treatment with ocular corticosteroid injections or implants (eg, by subconjunctival,
- •periocular, or
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