EUCTR2020-001313-20-IT进行中（未招募）1 期
A PHASE IIIb, GLOBAL, MULTICENTER, RANDOMIZED, VISUAL ASSESSOR-MASKED STUDY OF THE EFFICACY, SAFETY, AND PHARMACOKINETICS OF A 36-WEEK REFILL REGIMEN FOR THE PORT DELIVERY SYSTEM WITH RANIBIZUMAB IN PATIENTS WITH NEOVASCULAR AGE-RELATED MACULAR DEGENERATION (VELODROME) - VELODROME
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 442
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
- •General Inclusion criteria
- •¿Age >= 50 years
- •¿For women of childbearing potential: agreement to remain abstinent or use contraception and must remain abstinent or use contraceptive methods with a failure rate of <1% per year during the study, within 28 days after the final intravitreal ranibizumab injection and for 1 year after the final implant refill-exchange procedure or implantation of the PDS
- •Ocular inclusion criteria
- •¿Initial diagnosis nAMD within 9 months prior to the screening visit
- •¿Previous treatment with at least three anti- vascular endothelial growth factor (VEGF) intravitreal injections for nAMD per standard of care within 6 months prior to the screening visit
- •¿Demonstrated response to prior anti-VEGF intravitreal treatment since diagnosis
- •¿Availability of historical visual acuity data prior to the first anti-VEGF treatment for nAMD until the time of study enrollment
- •¿BCVA of 34 letters or better, using Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters at screening and enrollment visits
- •¿With any subtype of nAMD lesions
- •o nAMD lesions at the time of diagnosis must involve the macula (6-mm diameter centered at the fovea)
- •¿Sufficiently clear ocular media and adequate pupillary dilation to allow for analysis and grading by the central reading center of fundus photography, fluorescein angiography, fundus autofluorescence image, and OCT images
- •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 62
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 380
排除标准
- •Prior Ocular Treatment
- •Study Eye-History of vitrectomy surgery, submacular surgery, or other surgical intervention for AMD -Prior treatment with Visudyne®, external-beam radiation therapy, or transpupillary thermotherapy-Previous treatment with corticosteroid intravitreal injection, intraocular device implantation, previous laser used for AMD treatment
- •Treatment with anti-VEGF agents other than ranibizumab within 1 m prior to the enrollment visit- Concurrent conjunctival, Tenon's capsule, and/or scleral condition in the supero-temporal quadrant of the eye that may affect the implantation, subsequent tissue coverage, and refill-exchange procedure of the PDS implant
- •Either Eye- Pt who meet any of the following exclusion criteria related to CNV lesion
- •Study Eye-Subretinal hemorrhage that involves the center of the fovea, if the hemorrhage is greater than 0.5 disc area in size at screening-Subfoveal fibrosis or subfoveal atrophy-Either Eye-CNV due to other causes, such as ocular histoplasmosis, trauma, central serous chorio-retinopathy, or pathologic myopia
- •Concurrent Ocular Conditions-Pt who meet any of the following exclusion criteria related to concurrent ocular conditions
- •Study Eye-Retinal pigment epithelial tear-Any concurrent intraocular condition that would either require surgical intervention during the study to prevent or treat visual loss that might result from that condition or affect interpretation of study results-Active intraocular inflammation-History of pars plana vitrectomy surgery, vitreous hemorrhage, rhegmatogenous retinal detachment, retinal tears or peripheral retinal breaks within 3 m prior to the enrollment visit-Aphakia or absence of the posterior capsule-Spherical equivalent of the refractive error demonstrating more than 8 diopters of myopia-Preoperative refractive error that exceeded 8 diopters of myopia, for pt who have undergone prior refractive or cataract surgery in the study eye-Intraocular surgery within 3 m preceding the enrollment visit
- •Uncontrolled ocular hypertension or glaucoma and any such condition the investigator determines may require a glaucoma-filtering surgery during a patient's participation in the study-History of glaucoma-filtering surgery, tube shunts, or microinvasive glaucoma surgery -History of corneal transplant-Fellow Eye
- •Pt who meet the following exclusion criterion for the fellow (non-study) eye at both the screening and enrollment visits will be excluded from study entry:
- •Non-functioning study eye, defined as either:-BCVA of hand motion or worse-No physical presence of non-study eye
- •Either Eye-Any history of uveitis requiring treatment-Active infectious conjunctivitis, keratitis, scleritis, or endophthalmitis
- •Concurrent Systemic Conditions-Uncontrolled blood pressure-History of stroke within the last 3 m prior to icf-Atrial fibrillation diagnosed or worsened within the last 3 m prior to icf-History of myocardial infarction within the last 3 m prior to icf, other disease, metabolic dysfunction, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of ranibizumab or placement of the implant and that might affect interpretation of the results of the study or renders the pt at high risk of treatment complications in the opinion of the investigator-Confirmed active systemic infection
- •Use of any systemic anti-VEGF agents-Active cancer within 12 m of enrollment except for appropriately treated carcinoma in situ of the cervix, no
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