PER-077-07已完成未知
PROSPECTIVE, RANDOMIZED AND CONTROLLED STUDY OF EPI-RAD90 TM, OPHTHALMIC SYSTEM FOR THE TREATMENT OF SUBOVOLEOUS CHOROID NEOVASCULARISATION ASSOCIATED WITH MACULAR DEGENERATION OF WET TYPE ASSOCIATED WITH AGE
EOVISTA INC.,0 个研究点目标入组 0 人开始时间: 2007年11月7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 present predominantly classic, minimally classic or occult lesions without classic lesions, determined by the investigator, secondary to DMAE, with a total lesion size (including blood, scar deformity and neovascularization) of <12 total papillary areas (21.24 mm ) and a GLD <5.4 mm.
- •The lesions may be primary (newly diagnosed and untreated) or recurrent (previously diagnosed and with remission but which, at present, present a new active component);
- •The subjects should have visual acuity with correction of 69 to 24 letters using ETDRS optotypes (equivalent to 20/40 to 20/320 optotypes with the Snellen scale) in the eye under study. One single eye will be evaluated in the study. If both eyes meet the requirements to be included in the study, the one with the worst acuity will be the one selected for treatment and study. If only one eye meets the requirements, the vision in the eye not studied should be 20/400 or higher;
- •In case of subretinal hemorrhage, it should not cover more than 50% of the total size of the lesion and can not affect the subfoveal space;
- •Minimally classic lesions and non-classical occult lesions should show signs of possible recent progression of the disease defined as follows: a. The presence of subretinal hemorrhage and / or subretinal fluid and / or subretinal lipids. b. The loss of one or more lines of vision (ETDRS or equivalent) during the last six months c. Growth of the lesion confirmed by AF in> 10% during the last 6 months;
- •Subjects must be 50 years of age or older;
- •Subjects must be willing to return for scheduled treatment and follow-up exams for three years and be able to do so;
- •Women must be postmenopausal for 1 year or more or have undergone surgical sterilization. Otherwise, it will be necessary to perform a blood pregnancy test in the 14 days prior to randomization and this test should give a negative result.
排除标准
- •Subjects with previous or simultaneous treatment for subfoveolar CNV, including thermal laser photocoagulation (with or without photographic signs), photodynamic treatment, injections with Macugen®, steroids administered by intravitreal or subretinal injection, transpupillary thermotherapy (TTT) and antiangiogenic agents administered through intravitreal injection or systemic antiangiogenic agents in the studied eye. (Note: Subjects without known antecedents are included, but with photographic signs of previous treatment);
- •Subjects with concomitant disease in the eye studied, including uveitis, diabetic retinopathy, presence of tears in the retinal epithelium, acute periocular or ocular infection;
- •Subjects with advanced glaucoma (greater than a digging index / papilla of 0.8) or intraocular pressure> 30 mmHg in the studied eye;
- •Previous filtration surgery of glaucoma in the eye under study.
- •Subjects with retinal vasculopathies, including diabetic retinopathy, obstruction of retinal veins, etc. in the eye under study;
- •Subjects with subfoveal scar deformation, atrophy or hemorrhage in the studied eye;
- •Subjects in whom the CNV lesion in the eye under study contains more than 25% cicatricial deformity and / or atrophy;
- •Subjects with insufficient pupillary dilation or significant media opacity in the eye under study, including cataract, which may interfere with visual acuity or evaluation of the posterior segment;
- •Current vitreous hemorrhage in the eye under study;
- •History of rhegmatogenous retinal detachment or macular hole in the eye under study;
- •Subjects presenting choroidal neovascularization due to causes other than AMD, including ocular histoplasmosis syndrome, angioid striae, multifocal choroiditis, choroidal rupture or pathological myopia (spherical equivalent> 8 diopters or axial length> 25 mm);
- •Subjects undergoing intraocular surgery of the eye under study in the 12 weeks prior to the screening visit;
- •Subjects with previous posterior vitrectomy in the eye under study;
- •Subjects with known severe allergies to fluorescein used in angiography;
- •Subjects previously submitted to radiotherapy in the eye, head or neck;
- •Subjects with an intravitreal device or drug in the eye under study;
- •Subjects presenting any other process that, in the opinion of the researcher, could prevent the subject from completing the study (for example, dementia, mental disorder);
- •Subjects receiving prolonged treatment with systemic corticosteroids or other immunosuppressive therapy that may affect healing (eg, subjects who have received chemotherapy in the past 6 months) and immunosuppressed subjects (eg, HIV)
- •Subjects with a history of optic neuritis;
- •Subjects who have previously been diagnosed with diabetes mellitus type 1 or type 2 or who have signs on the retina indicative of it;
- •Previous intraocular surgery, except for cataract surgery. If the subject has undergone cataract surgery, the intervention must have been performed> 2 months before inclusion in the study;
- •Aphakia or lack of the posterior capsule in the eye under study. The opening of the posterior capsule is also excluded, unless it results from capsulotomy with yttrium-aluminum-garnet (YAG) associated with implant of intraocular lens in the posterior chamber (PCIOL);
- •Sensitivity or known allergy to Lucentis® (ranibizumab);
- •Current participation in a clinical
研究者
相似试验
招募中
不适用
Prospective, randomized, controlled study on the performance of the Swemed Sense single lumen aspiration needle with respect to bleeding, performed in Japan, 2013.InfertilityJPRN-UMIN000010915Kiba Park Clinic350
进行中（未招募）
1 期
A Prospective, randomized, clinical study on the effects of CPP-ACP paste on plaque, gingivitis and initial caries lesion development in orthodontic patients - part 2EUCTR2008-002982-30-BEniversity Hospital Ghent400
尚未招募
不适用
A Prospective and Randomized Controlled Trial of Empirical Formula of Traditinal Chinease Medicine in Treating Chronic Heart FailureHeart FailureITMCTR2100005097Chinese Academy of Medical Sciences Fuwai Hospital
已完成
不适用
Prospective randomized controlled study on the effect of Theranova on quality-of-life outcomes in maintenance dialysis patientsDiseases of The genitoruinary systemKCT0003026Kyungpook National University Hospital50
尚未招募
Unknown
Study to reduce the oocyte degeneration rate in oocytes with low oolemma extensibility during ICSI by re-puncture the oocyte from another site.Male infertility and failure to fertilize during in vitro fertilizationJPRN-UMIN000049763Sawada Women's Clinic400