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) - WR42221

F. Hoffmann-La Roche AG0 个研究点目标入组 442 人开始时间: 2024年6月13日最近更新: 2024年8月21日

适应症

试验速览

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•Ocular inclusion criteria: Initial diagnosis nAMD within 9 months prior to the screening visit, Ocular inclusion criteria: 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, Ocular inclusion criteria: Availability of historical visual acuity data prior to the first anti-VEGF treatment for nAMD until the time of study enrollment, Ocular inclusion criteria: 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, Ocular inclusion criteria: With any subtype of nAMD lesions -nAMD lesions at the time of diagnosis must involve the macula (6-mm diameter centered at the fovea), Ocular inclusion criteria: 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

•Prior Ocular Treatment: Study Eye History of vitrectomy surgery, submacular surgery, or other surgical intervention for AMD, Prior Ocular Treatment: Either Eye Prior participation in a clinical trial involving any therapies for nAMD, within 9 months from the time of nAMD diagnosis, CNV Lesion Characteristics: 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, Concurrent Systemic Conditions: Uncontrolled blood pressure, Concurrent Systemic Conditions: Use of any systemic anti-VEGF agents, Concurrent Systemic Conditions: Use of antimitotic or antimetabolite therapy within 30 days or 5 elimination half-lives of the enrollment visit

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