PER-019-19已完成未知
A MULTICENTER, DOUBLE-MASKED, RANDOMIZED, DOSE-RANGINGTRIAL TO EVALUATE THE EFFICACY AND SAFETY OF CONBERCEPTINTRAVITREAL INJECTION IN SUBJECTS WITH NEOVASCULAR AGE-RELATEDMACULAR DEGENERATIO
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 8
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. Men and women ≥ 50 years of age at the
- •Screening visit;
- •2. Females must be at least 1 year
- •postmenopausal, or surgically sterilized, or, if
- •of childbearing potential, must have a negative pregnancy test at the Screening visit; o Women of childbearing potential must agree to use a highly effective method of contraception throughout the study (See complete list in the Study
- •Procedures Manual);
- •3. Have received no previous treatment for neovascular AMD, including laser
- •photocoagulation and/or photodynamic therapy (PDT) and/or IVT VEGF antagonists (treatment naïve) and;
- •4. Have active subfoveal CNV lesions secondary to AMD (including polypoidal choroidal vasculopathy (PCV)) evidenced by subfoveal FA leakage, or definite subfoveal fluid by SD-OCT in the study eye at
- •5. Have CNV that is at least 50% of total lesion size in the study eye at Screening;
- •6. Have a ETDRS BCVA letter score of 78 to 25 (approximately 20/32 to 20/320 equivalent) in the study eye at Screening;
- •7. Have ocular media (lens, cornea, vitreous) of adequate clarity to permit high quality fundus imaging;
- •8. Are willing and able to sign the study written
- •informed consent form (ICF).
排除标准
- •1. Have had any prior ocular or systemic
- •treatment (investigational or approved) or
- •surgery for the treatment of neovascular AMD
- •in the study eye except dietary supplements or
- •2. Have participated as a subject in any
- •interventional clinical trial within one month
- •(30 days) prior to Baseline visit;
- •3. Have a total lesion size greater than twelve
- •disc areas (30.5 mm2), including blood,
- •fibrosis and neovascularization, as assessed by
- •FA in the study eye at Screening;
- •4. Have a subretinal hemorrhage that is either
- •50% or more of the total lesion area, or blood
- •is under the fovea and is one or more disc areas
- •in size (greater than 2.5 mm2) in the study eye
- •at Screening;
- •5. Have scarring or fibrosis making up greater
- •than 50% of total lesion in the study eye at
- •Screening; and/or scarring, fibrosis or atrophy
- •involving the center of the fovea in the study
- •eye at Screening;
- •6. Have any retinal pigment epithelial tears or
- •rips in the study eye at Screening or upon
- •examination at Baseline;
- •7. Have any vitreous hemorrhage in the study eye
- •upon examination at Baseline or history of
- •vitreous hemorrhage within eight weeks prior
- •to Screening;
- •8. Have any other cause of CNV, including
- •pathologic myopia (defined per protocol as
- •spherical equivalent of -8 diopters or more),
- •ocular histoplasmosis syndrome, angioid
- •streaks, inherited macular dystrophies,
- •choroidal rupture, uveitis, punctate inner
- •choroidopathy, or multifocal choroiditis in the
- •study eye at Screening;
- •9. Have a history of or clinical evidence of
- •significant diabetic retinopathy that could
- •impact assessment of vision or affect central
- •vision, diabetic macular edema, or any other
- •vascular disease other than AMD including
- •history or clinical evidence of retinal vein
- •occlusion affecting the study eye at Screening;
- •10. Have had prior pars plana vitrectomy in the
- •11. Have presence of a full thickness macular hole
- •at Screening or upon examination at Baseline
- •or a history of a full thickness macular hole in
- •the study eye;
- •12. Have a history of intraocular or periocular
- •surgery within three months of Baseline in the
- 另有 25 项未显示
研究者
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