EUCTR2017-002698-20-IT进行中（未招募）1 期
A dose-ranging study of intravitreal OPT-302 in combination withranibizumab, compared with ranibizumab alone, in participants withneovascular age-related macular degeneration (wet AMD) - A clinical study of OPT-302 with ranibizumab compared to ranibizumab alone in patients with neovasc
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 366
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. Active subfoveal choroidal neovascular (CNV) lesion or juxtafoveal
- •CNV lesion (1-199 µm from the fovea) with subfoveal involvement
- •(demonstrated by leakage on fluorescein angiography (FA) and/or intraretinal
- •or sub-retinal fluid on spectral-domain optical coherence
- •[SD-OCT]) secondary to age-related macular degeneration
- •Active CNV as measured on FA must constitute at least 50% of
- •lesion area, with a total lesion size of = 30.5 mm2. The lesion may
- •classic and/or occult CNV, but any occult CNV present must
- •< 10 mm2 on the FA. The characteristics of each lesion must be
- •by the Independent Reading Centre.
- •A best corrected (ETDRS) visual acuity (BCVA) score between 60 and
- •(inclusive) letters (Snellen equivalent of 20/63 (feet) or 6/21
- •and 20/320 (feet) or 6/96 (metres) respectively).
- •1. Willing and able to provide written informed consent.
- •2. Male or female participants at least 50 years of age.
- •3. Able to understand and willing to comply with study protocol
- •procedures and restrictions.
- •4. If female and of child-bearing potential: Pregnancy test at Screening
- •is negative, and agrees to use a highly effective method of contraceptive
- •for the duration of the study and for at least 3 months following the last
- •dose of study medication.
- •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 35
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 326
排除标准
- •1 Any previous treatment for wet AMD
- •2 Clinically significant ocular disorders other than wet
- •3 Haemorrhage measuring more than 50% of total lesion area
- •4 Fibrosis involving either the fovea centre or measuring more than
- •25% of the total lesion area and/or juxtafoveal or sub-foveal geographic
- •5 Choroidal neovascularisation due to causes other than AMD
- •6 Cloudy ocular media, or inadequate pupillary dilatation
- •7 Presence of intraocular inflammation (= trace cell or flare), significant
- •epiretinal membrane or vitreomacular traction, macular hole or vitreous
- •haemorrhage
- •8 Aphakia or absence of the posterior capsule
- •9 History of idiopathic or autoimmune-associated uveitis
- •10. Any current ocular or periocular infection
- •11 Intraocular pressure of greater than 25 mmHg
- •12 Myopia, or known former myopia, with a spherical equivalent of
- •Greater than 8 dioptres
- •13 Intraocular surgery within 6 months prior to screening, except for
- •Cataract surgery that is excluded within 3 months of Screening.
- •14 History of any of the following conditions or procedures:
- •Rhegmatogenous retinal detachment, filtering surgery
- •glaucoma drainage device, or corneal transplant.
- •15 Prior pars plana vitrectomy.
- •16 Presence of an intravitreal device.
- •17 Retinopathy
- •NON-STUDY EYE
- •History of idiopathic, autoimmune-associated, or infectious uveitis
- •1 diabetes mellitus
- •2 Administration of systemic steroids within 3 months of screening
- •3 Symptoms of heart failure
- •4 Unstable angina, myocardial infarction or coronary artery revascularisation within 6 months of screening.
- •5 Ventricular tachyarrhythmia requiring ongoing treatment
- •6 Vascular stenting within 6 months of screening
- •7 Cerebrovascular event
- •8 Diastolic blood pressure > 100 mmHg at screening.
- •9 Renal failure requiring dialysis or transplant.
- •10. ALT or AST = 2 x upper limit of normal or total bilirubin = 1.5
- •x ULN unless due to genetically confirmed Gilbert's disease
- •11 Any major surgical procedure
- •12 Active systemic infection
- •13 Malignancy within 5 years of screening, with the exception of
- •carcinoma in situ, non-melanoma skin cancers and prostate cancer not
- •requiring treatment or on stable (> 6 months) treatment with hormone
- •14 Known serious allergies to the fluorescein or hypersensitivity to
- •any of the listed excipients in the OPT-302 formulation or components of
- •the ranibizumab formulation
- •15 Pregnant, within 3 months after the end of pregnancy, planning to
- •become pregnant, or lactating.
- •16 Previous administration of anti-VEGF-A therapies except by intravitreal injection in the non-Study Eye
- •17 Administration of an investigational drug or ocular device within 30
- •days of screening, or 5 half-livesor any prior
- 另有 3 项未显示
研究者
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