EUCTR2005-005921-73-ES进行中（未招募）不适用
Estudio de fase IIIB, multicéntrico, abierto, de 12 meses de duración para evaluar la seguridad, tolerabilidad y eficacia de ranibizumab (0.3 mg) en pacientes con neovascularización coroidea subfoveal secundaria a la degeneración macular asociada a la edadA phase IIIb, open-label, multi-center 12 month study to evaluate the safety, tolerability and efficacy of ranibizumab (0.3 mg) in patients with subfoveal choroidal neovascularization secondary to age-related macular degeneration - SUSTAI
ovartis Farmacéutica, S.A.0 个研究点目标入组 500 人开始时间: 2006年2月27日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 500
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. Signed informed consent form
- •2. Male or female patients >50 years of age
- •3. Diagnosis of active primary or recurrent CNV secondary to AMD, including those with predominantly classic, minimally classic or occult lesions with no classic component
- •4. The total area of CNV (including both classic and occult components) encompassed within the lesion must be ³ 50% of the total lesion area
- •5. The total lesion area must be = 12 disc areas
- •6. Patients who have a BCVA score between 73 and 24 letters, inclusive, in the study eye using ETDRS-like grading charts (approximately 20/40 to 20/320)
- •7. Expectation by the investigator that patients will potentially benefit from ranibizumab treatment
- •Are the trial subjects under 18?
- •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. Previous treatment with intravitreally (in either eye) or intravenously administered Avastin ™ (bevacizumab)
- •2. Laser photocoagulation, treatment with intravitreal steroids, verteporfin photo dynamic therapy (Visudyne®) or pegaptanib sodium (Macugen®) in the study eye within 30 days preceding Day 1
- •3. Prior treatment in the study eye with external-beam radiation therapy, vitrectomy, or transpupillary thermotherapy.
- •4. History of surgical intervention in the study eye within two months preceding Day 1
- •5. Previous participation in any studies of investigational drugs within one month preceding Day 1(excluding vitamins and minerals and study CRFB002A2301)
- •6. Concurrent use of systemic anti-VEGF agents
- •7. Current use of or likely need for systemic medications known to be toxic to the lens, retina or optic nerve, including deferoxamine, chloroquine/ hydroxychloroquine (Plaquenil), tamoxifen, phenothiazines and ethambutol
- •8. Concomitant use of chronic NSAIDs for more than seven consecutive days or systemic or topical ocular corticosteroids for three or more consecutive days within six months prior to screening) or at any time during the study. Note that ASA (aspirin) taken as low dose” up to 100 mg qd for prophylaxis of myocardial infarction and/or stroke is permitted during study
- •9. Previous treatment with or participation in a clinical trial (for either eye) involving anti angiogenic drugs (pegaptanib, ranibizumab, anecortave acetate or corticosteroids, etc.).
- •10. Ocular disorders in the study eye that may confound interpretation of study results, including retinal detachment or macular hole (Stage 3 or 4), active intraocular inflammation (grade trace or above) or persistent macular edema due to uveitis or other inflammatory diseases
- •11. Concurrent disease in the study eye that could compromise visual acuity or require medical or surgical intervention during the 12-month study period
- •12. Vitreous hemorrhage or history of rhegmatogenous retinal detachment or macular hole in the study eye
- •13. Presence of retinal pigment epithelial tear involving the macula in the study eye
- •14. History of idiopathic or autoimmune-associated uveitis in either eye
- •15. Active infectious conjunctivitis, keratitis, scleritis or endophthalmitis in either eye.
- •16. History of glaucoma filtration surgery or corneal surgery
- •17. Extracapsular extraction of cataract with phacoemulsification within 2 months preceding Day 1, or a history of post-operative complications within the last 12 months preceding Day 1 in the study eye (uveitis, cyclitis etc.)
- •18. Uncontrolled glaucoma in the study eye (defined as intraocular pressure = 25 mmHg despite treatment with anti-glaucoma mediation).
- •19. Aphakia or absence of the posterior capsule in the study eye. Previous violation of the posterior capsule in the study eye is also excluded unless it occurred as a result of YAG posterior capsulotomy in association with prior, posterior chamber intraocular lens implantation
- •20. Spherical equivalent of the refractive error in the study eye demonstrating more than –8 diopters of myopia; for subjects who have undergone prior refractive or cataract surgery in the study eye, the preoperative refractive error in the study eye can not exceed -8 diopters of myopia
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