EUCTR2015-000519-42-FR进行中（未招募）1 期
Role of multimodal imaging in the evaluation of anatomic alterations in neovascular Age-Related Macular Degeneration (AMD) subjects: 18 month Phase 2a open label study of Fovista® (anti-PDGF therapy) administered in combination with anti-VEGF therapy
OPHTHOTECH CORPORATIO0 个研究点目标入组 32 人开始时间: 2015年8月5日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 32
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
入选标准
- •Ophthalmic Inclusion Criteria:
- •The following inclusion criteria apply to the study eye:
- •- Best corrected visual acuity in the study eye between 20/40 and 20/200, inclusive. The VA must be re-confirmed at Day 1 prior to randomization.
- •- Total area of the lesion (including blood, neovascularization, and scar/atrophy) must be = 9 disc areas (DA)
- •- Presence of subfoveal Active CNV. Active CNV” is defined as presence of fluorescein leakage consistent with choroidal neovascularization.
- •- Sub or intraretinal fluid in the anatomic fovea by OCT
- •- Clear ocular media and adequate pupillary dilatation to allow collection of fundus photographs and fluorescein angiograms of a sufficient quality to be analyzed by the central reading center.
- •- Intraocular pressure (IOP) of 21 mmHg or less
- •- Treatment naïve subjects or treatment experienced subjects which is defined as subjects with 2 prior sequential monthly doses of intravitreal anti-VEGF therapy given within the past 12 weeks. For treatment experienced subjects, there must be a VA change of = 0 letters per Snellen VA score since the last anti-VEGF injection.
- •General Inclusion Criteria:
- •- Subjects of either gender aged =50 years.
- •- Women must agree to be using two forms of effective contraception, be post-menopausal for at least 12 months prior to trial entry, or surgically sterile; if of child-bearing potential, a serum pregnancy test must be performed within 14 days prior to the first injection with a negative result. The two forms of effective contraception must be implemented during the trial and for at least 60 days following the last dose of test medication.
- •- Provide written informed consent.
- •- Ability to comply with study and follow-up procedures and return for all trial visits.
- •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 60
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 60
排除标准
- •Ophthalmic Exclusion Criteria:
- •- Intravitreal treatment (including intravitreal corticosteroids) in the study eye prior to the Day 1 visit, regardless of indication, with the exception of two prior anti-VEGF injections for the Treatment Experienced cohort.
- •- Subjects with atrophy or scar within 1 disc area (DA) of the center of the fovea are excluded.
- •- Presence of significant serous pigment epithelial detachments (PEDs), such as large PEDs that constitute greater than 50% of the total lesion or have a vertical height of = 600 µm.
- •- Presence of pure PED without subretinal hyper-reflective material.
- •- Presence of pigment epithelial tears or rips.
- •- Presence of intraocular inflammation, significant epiretinal membrane (causing distortion of macular anatomy and/or opacification), significant vitreomacular traction (causing distortion of macular anatomy), macular hole (full or partial thickness) or vitreous hemorrhage.
- •- Aphakia or absence of the posterior capsule. Absence of an intact posterior capsule is allowed if it occurred as a result of YAG laser posterior capsulotomy in association with prior posterior chamber IOL implantation.
- •- History of idiopathic or autoimmune-associated uveitis in either eye.
- •- Significant media opacities, including cataract, which may interfere with visual acuity assessment or fundus photography evaluation of the study eye (i.e. foveal atrophy, fibrosis, etc.).
- •- Significant likelihood of requiring cataract surgery in the study eye in the next 12 months.
- •- Presence of other causes of choroidal neovascularization, including pathologic myopia (spherical equivalent of -8 diopters or more, or axial length of 25mm or more), ocular histoplasmosis syndrome, angioid streaks, choroidal rupture, and multifocal choroiditis.
- •- Non-pharmacologic treatment (intraocular surgery or thermal laser) within three (3) months of trial entry.
- •- Prior thermal laser in the macular region, regardless of indication.
- •- Ocular or periocular infection in the past twelve (12) weeks.
- •- History of any of the following conditions or procedures in the study eye: rhegmatogenous retinal detachment, pars plana vitrectomy, filtering surgery (e.g. trabeculectomy), glaucoma drainage device, or corneal transplant.
- •- Previous therapeutic radiation in the region of the study eye.
- •General Exclusion Criteria:
- •- Any of the following underlying conditions or diseases including:
- •A definitive diagnosis of diabetes mellitus or diabetic retinopathy (regardless of HbA1c level)
- •HbA1c value of =6.5% (If the HbA1c value is = 6.5% and = 6.9%, and the patient has no signs or symptoms of diabetes mellitus, has a normal creatinine, has no diabetic retinopathy and no glycosuria, then the patient may have an oral glucose tolerance test (OGTT) at the discretion of the investigator. If the 2-hour glucose value on OGTT is <200 mg/dL (<11.1mmol/L), then the patient may be enrolled.)
- •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 of an investigational drug or that might affect in
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