PER-063-08已完成未知
A Phase III, Double-masked, Multicenter, Randomized, Sham Injection-controlled Study of the Efficacy and Safety of Ranibizumab Injection in Subjects With Clinically Significant Macular Edema With Center Involvement Secondary to Diabetes Mellitus
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 4
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
- 年龄范围
- 18 至 99（—）
- 性别
- All
入选标准
- •Willingness to grant informed consent, in writing and, in US centers, authorization by the Health Insurance Portability and Accountability Act (HIPAA) and in other countries, as provided by national laws
- •Age> 18 years
- •Diabetes mellitus (Type 1 or 2)
- •Retinal thickening secondary to diabetes mellitus (DME) with compromise of the fovea center with a central macular thickness> 2.75 um in the central subfield, as assessed by OCT and confirmed by the central image reading center (UWFPRC) only at the screening visit and by the evaluating physician on Day 0
- •BCVA score in the study eye from 20/40 to 20/320, equivalent to Snellen, using the ETDRS protocol at an initial evaluation distance of 4 meters, confirmed by the researcher
- •Decreased vision determined primarily as a consequence of DME and not from other causes
- •For potentially fertile and sexually active women, the use of an appropriate contraceptive method (or abstinence) for the duration of the study
排除标准
- •History of vitreoretinal surgery in the eye under study
- •Panretinal photocoagulation (PRP) or macular photocoagulation with laser in the eye under study within 3 months of selection
- •Previous use of intraocular corticosteroids in the eye under study (eg, TA) within 3 months of selection
- •Previous treatment with antiangygogenic drugs in any of the eyes (pegaptanib sodium, anecortave acetate, bevacizumab, ranibizumab, etc.) within 3 months of the Day 0 visit
- •PDR in the eye under study, with the exception of inactive POR, already submitted
- •Neovascularization of the iris, vitreous hemorrhage, retinal detachment by traction, or pre-retinal fibrosis with macular involvement in the study eye
- •Vitreomacular traction or epiretinal membrane in the eye under study, detected biomicroscopically or by means of OCT; and that the researcher does not consider that they significantly affect central vision nn
- •Eye inflammation (from traces or more) in the eye under study
- •History of idiopathic or autoimmune uveitis in either of both eyes
- •Structural damage to the center of the macula in the study eye with a probability of preventing an improvement in VA after the resolution of macular edema, including atrophy of the RPE, sub-retinal fibrosis or organized hard exudate in plaque.
- •Eye conditions in the eye under study that could confuse interpretation of study results, including retinal vascular occlusion, retinal detachment, macular hole, or CNV of any origin (eg, AMD, ocular histoplasmosis, or pathological myopia)
- •Concurrent eye disease in the study that could compromise VA or require medical or surgical intervention during the study period
- •Cataract surgery in the eye under study within 3 months, capsulotomy with yttrium-aluminum-garnet (YAG) laser in the previous 2 months, or any other intraocular surgery within 90 days prior to Day 0
- •Aphakia or absence of the posterior capsule in the eye under study. Previous rupture of the posterior capsule is also excluded unless it had occurred as a consequence of the posterior capsulotomy with YAG laser associated with anterior implantation of a posterior chamber infra-ocular lens.
- •Uncontrolled glaucoma (defined as an IOP> 30 mmHg despite treatment with glaucoma medication) or previous filtration surgery in the study eye
- •Spherical equivalent of refractive error in the eye in a study of more than -8 diopters of myopia (in patients who already had refractive surgery or cataract in the eye under study, spherical equivalent of pre-surgical refractive error of more than -8 diopters of myopia )
- •Evidence in the examination of blepharitis, keratitis, scleritis or infectious conjunctivitis in any eye, or current treatment for serious systemic infection
- •Uncontrolled blood pressure (defined as systolic> 180 mmHg and diastolic> 110 mmHg with the patient sitting)
- •History of stroke or myocardial infarction within 3 months prior to Day 0
- •Uncontrolled diabetes mellitus, evidenced by a HbA1c value> 12%
- •Kidney failure requiring dialysis or kidney transplantation
- •Participation in a research trial within 30 days prior to selection that involves treatment with any drug (excluding vitamins and minerals) b device
- •History of any other disease, metabolic dysfunction, finding in the physical examination, or finding in the results of clinical laboratory that could generate a reasonable suspicion of disease or in w
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