EUCTR2011-000536-28-DE进行中（未招募）不适用
Safety and efficacy study with ESBA1008 versus Lucentis for the treatment of exudative age-related macular degeneration
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 194
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
- •1. Patient must give written informed consent, be able to make the
- •required study visits and follow instructions
- •2. Patient must be 50 years of age or older
- •3. Patient’s study eye must have:
- •primary subfoveal choroidal neovascularization (CNV) secondary to AMD, including predominantly classic, minimally classic or occult lesions
- •a lesion area < 30 mm2 (12 disc areas) of any lesion type (predominantly classic, minimally classic or occult)
- •total area of CNV (including both classic and occult components) must comprise > 50% of the total lesion area. Total lesion area is defined as the area with angiographic evidence of neovascularization, associated contiguous areas of serous elevation of the RPE, elevated blocked fluorescence, and/or late staining
- •a new diagnosis of exudative AMD or evidence of recent disease progression within the last 3 months; if the CNV in the study eye is minimally classic or occult, evidence of recent disease progression is defined as having experienced a loss of at least 1 line of vision (5 ETDRS letters or one Snellen line), a change in lesion size of more than 2.54 mm2 (1 disc area) or the appearance of new blood in the lesion
- •subretinal blood, if present, must spare the fovea and must comprise <50% of the total lesion
- •evidence of subretinal fluid or retinal cystic changes with a central subfield thickness (CSF) of > 340 µm using a Spectralis SD-OCT (Heidelberg Engineering) imaging system
- •a best-corrected visual acuity (BCVA) ranging between 73 letters (20/40 Snellen equivalent) and 34 letters (20/200 Snellen equivalent), inclusive
- •clear ocular media and adequate pupil dilation to permit good
- •quality photographic imaging
- •4. Patient’s fellow eye BCVA must be 34 letters (Snellen equivalent
- •20/200) or better
- •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 40
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 154
排除标准
- •Shortened from protocol:
- •1. Patient received any previous treatment for AMD in the study eye
- •2. Any current or history of ocular disease in the study eye
- •3. Any evidence of fibrosis or scarring in the study eye
- •4. Any vitreous hemorrhage or history of rhegmatogenous retinal detachment in the study eye
- •5. Any previous surgery in the study eye (penetrating keranoplasty, vitrectomy, cataract surgery, LASIK or cataract removal in the last 3 months)
- •6. any active infection or inflammation in the study eye
- •7. uncontrolled glaucoma
- •8. aphakia in the study eye
- •9. use of topical or systemic cortecosteroids
- •10. history of a chronic medical condition that precludes study participation
- •11. laboratory abnormalities that would make the patient unsuitable for the study
- •12. severe hypersensitivity to any of the components of the IMPs that are being used in the study
- •13. Pregnant and breast-feeding women
- •14. participation in another clinical study within the last 30 days
- •15. CNV due to other reasons than AMD
研究者
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