PER-065-15招募中未知
SAFETY AND EFFICACY OF ABICIPAR PEGOL (AGN-150998) IN PATIENTS WITH NEOVASCULAR AGE-RELATED MACULAR DEGENERATIO
适应症
试验速览
- 阶段
- 未知
- 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
- 年龄范围
- 50 至 99（—）
- 性别
- All
入选标准
- •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).
- •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.
- •8. BCVA of 34 letters (Snellen equivalent 20/200) or better at baseline (day 1), prior to treatment.
排除标准
- •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 (Section 4.5.1.1)
- •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 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).
- •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.
- •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 wi
研究者
相似试验
进行中（未招募）
1 期
Study to determine (find out) the Safety and Efficacy of Abicipar Pegol (AGN-150998) in Patients with Neovascular Age-related Macular Degeneratioeovascular age-related macular degeneration (AMD).EUCTR2014-004580-20-PLAllergan Ltd.949
进行中（未招募）
1 期
Study to determine (find out) the Safety and Efficacy of Abicipar Pegol (AGN-150998) in Patients with Neovascular Age-related Macular DegeneratioEUCTR2014-004579-22-DEAllergan Ltd.926
进行中（未招募）
1 期
Study to determine (find out) the Safety and Efficacy of Abicipar Pegol (AGN-150998) in Patients with Neovascular Age-related Macular Degeneratioeovascular age-related macular degeneration (AMD).EUCTR2014-004579-22-ATAllergan Ltd.926
进行中（未招募）
1 期
Study to determine (find out) the Safety and Efficacy of Abicipar Pegol (AGN-150998) in Patients with Neovascular Age-related Macular DegeneratioEUCTR2014-004580-20-ITAllergan Ltd.949
进行中（未招募）
1 期
Study to determine (find out) the Safety and Efficacy of Abicipar Pegol (AGN-150998) in Patients with Neovascular Age-related Macular DegeneratioEUCTR2014-004579-22-CZAllergan Ltd.926