EUCTR2007-003042-15-PT进行中（未招募）不适用
A Phase 3, randomized, double-masked, parallel-assignment study of intravitrealbevasiranib sodium, administered every 8 or 12 weeks as maintenance therapyfollowing three injections of Lucentis® compared with Lucentis® monotherapy every4 weeks in patients with Exudative Age-Related Macular Degeneration (AMD) - COBALT
Opko Health, Incorporated0 个研究点目标入组 330 人开始时间: 2007年7月27日最近更新:
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 330
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
- •1. Patients must have predominantly classic, minimally classic, or occult with no classic lesions, secondary to AMD, with a total lesion size (including blood, scarring and neovascularization) of = 12 total disc areas (30.48 mm2);
- •2. Patients must have ETDRS best corrected visual acuity of 69 to 24 letters (20/40 to 20/320 Snellen Equivalent) in the study eye;
- •3. Occult with no classic lesions must have evidence of presumed recent disease progression defined as:
- •a. The presence of subretinal hemorrhage OR
- •b. Loss of > 1 line of VA during the past 12 weeks OR
- •c. FA documented lesion growth by = 10% during the past 12 weeks;
- •4. Patients must be age 50 or older;
- •5. Patient must sign and retain a copy of the written informed consent form;
- •6. Patients must be willing and able to return for scheduled follow-up examinations for two years; and
- •7. Women must be post-menopausal = 1 year, or surgically sterilized. If not, a negative serum pregnancy test is required within 14 days of randomization.
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Patients who have been previously treated for AMD in the study eye with any agent except vitamins and/or minerals;
- •2. Patients with concomitant disease in the study eye, including uveitis, presence of pigment epithelial tears or rips, acute ocular or periocular infection;
- •3. Patients with advanced glaucoma (greater than 0.8 cup:disk) or intraocular pressure above 22mmHg in the study eye despite adequate treatment with medication;
- •4. Patients with any retinal vasculopathies, including diabetic retinopathy, retinal vein occlusions, etc. in the study eye;
- •5. Patients with any subfoveal scarring, atrophy, or hemorrhage > 500µm in the study eye;
- •6. Patients whose CNV lesion in the study eye contains more than 25% scarring and/or fibrosis;
- •7. Patients with inadequate pupillary dilation or significant media opacities in the study eye, which may interfere with visual acuity or the evaluation of the posterior segment, including cataract, which is likely to require surgical intervention within the 100 week active study period;
- •8. Patients who present with choroidal neovascularlization due to causes other than AMD, including ocular Histoplasmosis syndrome, angioid streaks, multifocal choroiditis, choroidal rupture, or high myopia
- •(spherical equivalent = 8 Diopters or axial length = 25mm);
- •9. Patients who have undergone any intraocular surgery of the study eye within 12 weeks prior to the screening visit;
- •10. Patients who have undergone any extrafoveal/juxtafoveal laser treatment of the study eye within two weeks prior to the screening visit;
- •11. Patients with previous posterior vitrectomy of the study eye;
- •12. Patients with known serious allergies to fluorescein dye, not amenable to treatment with diphenhydramine;
- •13. Patients who underwent previous radiation therapy to the head or neck in the region of the study eye;
- •14. Patients who received treatment with any investigational drug within 4 weeks prior to the screening visit;
- •15. Patients with an intravitreal device or drug implant in the study eye;
- •16. Patients with a recent history of acute coronary syndrome, coronary angioplasty, aorto-coronary bypass, or stroke.
- •17. Patients with any other condition, which in the judgment of the investigator would prevent the patient from completing the study;
- •18. Premenopausal women not using adequate contraception.
研究者
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