PER-099-07已完成未知
A STUDY TO EVALUATE THE SAFETY AND FEASIBILITY OF FOCAL EPIRETINAL RADIOTHERAPY AND RANIBIZUMAB (LUCENTIS®) FOR THE TREATMENT OF SUBFOVEAL CHOROIDAL NEOVASCULARIZATION (CNV) SECONDARY TO AGE-RELATED MACULAR DEGENERATION (AMD)
EOVISTA INC.,0 个研究点目标入组 0 人开始时间: 2008年4月1日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
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
- 0 至 0（—）
入选标准
- •Subjects must have predominantly classic, minimally classic, or occult with no classic lesions, as determined by the Investigator, secondary to AMD, with a total lesion size (including blood, scarring, and neovascularization) of < 12 total disc areas (21.24 mm^), and a GLD <5.4 mm;
- •Lesions may be primary (newly diagnosed and untreated) or recurrent (previously diagnosed and regressed but currently presenting with a new, active component);
- •Subjects must have ETDRS best corrected visual acuity of 69 to 24 letters (20/40 to 20/320 Snellen Equivalent) in the study eye a) Only one eye will be assessed in the study. If both eyes are eligible, the one with the worse acuity will be selected for treatment and study. If only one eye is eligible, vision in the non-study eye must be 20/400 or better;
- •Subretinal heme (if any) must not comprise more than 50% of total lesion size, and may not involve the subfoveal space;
- •Minimally classic and occult with no classic lesions must have evidence of presumed recent disease progression defined as: a. The presence of subretinal hemorrhage and/or fluid and/or lipid OR b. Loss of one or more lines of vision (ETDRS or equivalent) during the past six months OR c. FA documented lesion growth by > 10% during the past 6 months;
- •Subjects must be age 50 or older;
- •Subjects must be willing and able to return for scheduled treatment and follow-up examinations for three years;
- •Women must be post-menopausal >1 year or surgically sterilized. If not, negative serum pregnancy test required within 14 days prior to randomization.
排除标准
- •Subjects with prior or concurrent subfoveal CNV therapy including thermal laser photocoagulation (with or without photographic evidence), photodynamic therapy, injections with Macugen®, intravitreal or subretinal steroids, transpupillary thermotherapy (TTT), and systemic anti-angiogenic or intravitreal anti-angiogenic agents in study eye.
- •Subjects with concomitant disease in the study eye, including uveitis, diabetic retinopathy, presence of pigment epithelial tears or rips, acute ocular or periocular infection;
- •Subjects with advanced glaucoma (greater than 0.8 cup:disk) or intraocular pressure > 30 mmHg in the study eye;
- •Previous glaucoma filtering surgery in the study eye;
- •Subjects with any retinal vasculopathies, including diabetic retinopathy, retinal vein occlusions, etc. in the study eye,
- •Subjects with any subfoveal scarring, atrophy, or hemorrhage in the study
- •Subjects whose CNV lesion in the study eye contains more than 25% scarring and/or atrophy; ^ ,
- •8 Subjects with inadequate pupillary dilation or significant media opacities in the study eye, including cataract, which may interfere with visual acuity or the evaluation of the posterior segment,
- •Current vitreous hemorrhage in the study eye,
- •History of rhegmatogenous retina detachment or macular hole in the study eye;
- •Subjects who present with choroidal neovascularization due to causes other than AMD, including ocular Histoplasmosis syndrome, angioid streaks, multifocal choroiditis, choroidal rupture, or pathologic myopia (spherical equivalent > 8 Diopter or axial length > 25mm);
- •Subjects who have undergone any intraocular surgery of the study eye within 12 weeks prior to the screening visit;
- •Subjects with previous posterior vitrectomy of the study eye;
- •Subjects with known serious allergies to fluorescein dye used in angiography;
- •Subjects who underwent previous radiation therapy to the eye, head or neck;
- •Subjects with an intravitreal device or drug in the study eye;
- •Subjects with any other condition, which in the judgment of the investigator would prevent the subject from completing the study (e.g. dementia, mental illness);
- •Subjects on chronlc systemic corticosteroid or other immunosuppressive therapy that may affect wound healing (e.g. subjects who have undergone chemotherapy within the last 6 months), and any immunocomprom.sed subjects (e.g. HIV);
- •Subjects with a history of optic neuritis;
- •Subjects that have been previously diagnosed or have retinal findings consistent with Type 1 or Type 2 Diabetes Mellitus,
- •Previous intraocular surgery, excluding cataract surgery. If the subject has had cataract surgery, it must have been > 2 months prior to entry into the study;
- •Aphakia or absence of the posterior capsule in the study eye. Previous violation of the posterior capsule is also excluded unless it occurred as a result of yttrium aluminum garnet (YAG) capsulotomy in association with PCIOL implantation;
- •Known sensitivity or allergy to Lucentis®(ranibizumab);
- •Current participation in another drug or device clinical trial, or participation in such a clinical trial within the last year (this does not include patients in clinical triais assessing the efficacy of dietary supplements);
- •History of use of drugs with known retinal toxicity, including: chloroquine (Aralen - an anti-malarial drug),hydroxychIoriquine (Plaquenil), phenothiazine
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