EUCTR2005-005921-73-GB进行中（未招募）1 期
A 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
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
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
入选标准
- •1. Male or female patients =50 years of age
- •2. Diagnosis of active primary or recurrent CNV secondary to AMD, including those with predominantly classic, minimally classic or occult lesions with no classic component
- •3. The total area of CNV (including both classic and occult components) encompassed within the lesion must be =50% of the total lesion area
- •4. The total lesion area must be = 12 disc areas
- •5. 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)
- •6. Expectation by the investigator that patients will potentially benefit from ranibizumab treatment
- •7.Willing and able to give written informed consentaccording to legal requirements, and who have signed the consent form prior to intiation of any study procedure.
- •8. Willing and able to comply with all study procedures.
- •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. 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)
- •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, compromise visual acuity or require medical or surgical intervention during the 12-month study period (see protocol for more information)
- •11. History of idiopathic or autoimmune-associated uveitis in either eye
- •12. History of glaucoma filtration surgery or corneal surgery
- •13. 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.)
- •14. Uncontrolled glaucoma in the study eye (defined as intraocular pressure > or = 25 mmHg despite treatment with anti-glaucoma medication).
- •15. Aphakia (no lens) or absence of the posterior capsule in the study eye.
- •16. 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.
- •17. Patients with angioid streaks or presursors of CNV in either eye due to other causes, such as ocular histoplasmosis, trauma or pathologic myopia
- •18. Patients who have BCVA of <34 letters in both eyes
- •19. History of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that might affect interpretation of the results of the study or render the subject at high risk for treatment complications
- •20. Evidence of significant uncontrolled concomitant diseases such
研究者
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