EUCTR2014-002381-73-GB进行中（未招募）1 期
Individualizing therapy for neovascular age-related macular degeneration with aflibercept - VITA
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
- 50
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
- •Newly diagnosed, angiographically documented, previously untreated, active CNV lesion (i.e., leakage on fluorescein angiography AND subretinal, intraretinal, or sub-RPE fluid on OCT) secondary to age-related macular degeneration.
- •Best corrected visual acuity score in the study eye of between 80 and 23 letters inclusive, using ETDRS testing, (between 6/7.5 and 6/96 Snellen equivalent), inclusive.
- •The CNV or sequela of the CNV (i.e., pigment epithelium detachment, subretinal haemorrhage, blocked fluorescence, macular edema, or subretinal or intraretinal fluid) must involve the centre of the fovea.
- •The total area of fibrosis must comprise less than 50% of the total lesion.
- •> 1 drusen (>63 microns) in either eye OR late AMD in fellow eye.
- •No previous treatment for CNV in the study eye.
- •Clear ocular media and adequate pupillary dilation to permit good quality fundus imaging.
- •Signed informed consent form
- •Age = 50 years of either gender
- •Women must be postmenopausal for at least 12 months prior to trial entry, or surgically sterile. If of child bearing potential, a serum pregnancy test with a negative result must be obtained within 14 days prior to the first treatment.
- •Women of child bearing potential must be practicing effective contraception implemented during the trial and for at least 60 days following the last dose of study medication.
- •No condition that precludes follow-up for 2 years.
- •No contraindication to intravitreous injection of aflibercept
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 0
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •Any previous treatments for wet AMD (including verteporfin PDT, Macugen®, Lucentis®, intravitreous Avastin®, thermal laser, external beam radiation or surgery for AMD) in the study eye
- •Current or planned use of systemic medications known to be toxic to the lens, retina or optic nerve, including deferoxamine, chloroquine/ hydroxychloroquine (Plaquenil®), phenothiazines and ethambutol.
- •Previous participation in any studies of investigational drugs likely to have ocular effects within 30 days preceding the initial study treatment
- •Concurrent or previous use of systemic anti-VEGF agents.
- •Any intraocular procedure (including Yttrium-Aluminium-Garnet capsulotomy) within 2 months prior to Screening or anticipated within the next 6 months following Screening
- •Permanent structural damage (fibrosis or atrophy) involving the centre of the fovea in the study eye
- •CNV in either eye due to other causes, such as ocular histoplasmosis, trauma, or pathologic myopia
- •Retinal pigment epithelial tear involving the fovea in the study eye
- •Any concurrent intraocular condition in either eye (e.g., cataract or diabetic retinopathy) that, in the opinion of the investigator, could either require medical or surgical intervention during the 2 year follow-up period to prevent or treat visual loss that might result from that condition, or, if allowed to progress untreated, could likely contribute to loss of at least 2 Snellen equivalent lines of best corrected visual acuity over the 2 year follow-up period.
- •Active or recent (within 4 weeks) intraocular inflammation (grade trace or above) in either eye
- •Neovascularisation of the iris, neovascular glaucoma or vitreous haemorrhage in either eye at the screening visit
- •History of rhegmatogenous retinal detachment, epiretinal membrane, vitreomacular traction or macular hole in the study eye if in the investigators opinion, thought to limit potential for vision improvement after treatment for wet AMD
- •History of vitrectomy in study eye
- •Active infectious conjunctivitis, blepharitis, keratitis, scleritis, or endophthalmitis in either eye at the time of screening
- •Spherical equivalent of the refractive error in the study eye demonstrating more than 8 diopters of myopia
- •For subjects who have undergone prior refractive or cataract surgery in the study eye, the preoperative refractive error in the study eye cannot exceed 8 diopters of myopia.
- •Intraocular surgery (including cataract surgery) in the study eye within 2 months preceding the first study treatment.
- •Uncontrolled glaucoma in either eye at the time of screening (defined as intraocular pressure >25 mmHg despite treatment with anti-glaucoma medication)
- •Inability to be photographed or to document CNV (eg due to allergy to fluorescein dye, lack of venous access or cataract obscuring the CNV).
- •Inability to obtain OCT images of reasonable quality to allow analysis of lesion or macular fluid
- •Other ocular diseases or conditions that can compromise the visual acuity of the study eye such as amblyopia, anterior ischemic optic neuropathy, previous complicated cataract surgery, aphakia, vitreomacular traction or diabetic macular oedema
- •Pregnancy or breastfeeding
- •History of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use an investigational drug or that might affect interpretation of the results of the study or render the subject at high r
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