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A 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)
442 patients around the world
Available in Argentina, Brazil, Spain
Hoffmann-La Roche
8Research sites
442Patients around the world
This study is for people with
Macular Degeneration
Age-related Macular Degeneration
Requirements for the patient
From 50 Years
All Gender
Medical requirements
- Age ≥ 50 years at time of signing Informed Consent FormInitial diagnosis of nAMD within 9 months prior to the screening visitPrevious 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 visitDemonstrated response to prior anti-VEGF intravitreal treatment since diagnosisAvailability of historical visual acuity data prior to the first anti-VEGF treatment for nAMD until the time of study enrollmentBCVA of 34 letters (approximate 20/200 Snellen equivalent) or better
- History of vitrectomy surgery, submacular surgery, or other surgical intervention for AMD in study eyePrior treatment with Visudyne®, external-beam radiation therapy, or transpupillary thermotherapy in study eyePrevious treatment with corticosteroid intravitreal injection, intraocular device implantation, previous laser (any type) used for AMD treatment in study eyeTreatment with anti-VEGF agents other than ranibizumab within 1 month prior to the enrollment visit in study eyeConcurrent 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 implantPrior treatment with brolucizumab (at any time prior to the screening visit) in either eyePrior participation in a clinical trial involving any anti-VEGF drugs, within 6 months prior to the enrollment visit in either eyeSubretinal hemorrhage that involves the center of the fovea, if the hemorrhage is >0.5 disc area at screening in study eyeSubfoveal fibrosis or subfoveal atrophy in study eyeCNV due to other causes, such as ocular histoplasmosis, trauma, central serous chorio-retinopathy, or pathologic myopia in either eyeRetinal pigment epithelial tear in study eyeAny 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 in study eyeActive intraocular inflammation in study eyeHistory of vitreous hemorrhage in study eyeHistory of rhegmatogenous retinal detachment in study eyeHistory of rhegmatogenous retinal tears or peripheral retinal breaks within 3 months prior to the enrollment visit in study eyeHistory of pars plana vitrectomy surgeryAphakia or absence of the posterior capsule in study eyeSpherical equivalent of the refractive error demonstrating more than 8 diopters of myopia in study eyePreoperative refractive error that exceeded 8 diopters of myopia, for Participants who have undergone prior refractive or cataract surgery in study eyeIntraocular surgery within 3 months preceding the enrollment visit in study eyeUncontrolled ocular hypertension or glaucoma and any such condition the investigator determines may require a glaucoma-filtering surgery during a participant's participation in the study in study eyeHistory of glaucoma-filtering surgery, tube shunts, or microinvasive glaucoma surgery in study eyeHistory of corneal transplant in study eyeAny history of uveitis requiring treatment in either eyeActive infectious conjunctivitis, keratitis, scleritis, or endophthalmitis in either eyeUncontrolled blood pressureHistory of stroke within the last 3 months prior to informed consentAtrial fibrillation diagnosed or worsened within the last 3 months prior to informed consentHistory of myocardial infarction within the last 3 months prior to informed consent,History of 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 participant at high risk of treatment complications in the opinion of the investigatorConfirmed active systemic infectionUse of any systemic anti-VEGF agentsActive cancer within 12 months of enrollment except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, and prostate cancer with a Gleason score of <= 6 and a stable prostate-specific antigen for > 12 monthsPrevious participation in any non-ocular disease studies of investigational drugs within 1 month preceding the informed consentNon-functioning non-study eye
Sites
Centro Oftalmológico Dr. Daniel Charles
Recruiting
Instituto Oftalmológico de Buenos Aires / Oftalmos
Recruiting
Grupo Laser Vision
Recruiting
Botelho Hospital da Visão
Recruiting
Vision Institute - IPEPO (IPEPO - Instituto da Visão - Vila Clementino)
Recruiting
Retina Clinic
Recruiting
BOS - Banco de Olhos de Sorocaba | Hospital Oftalmológico de Sorocaba
Recruiting
Universidad Federal de São Paulo - Unifesp
Recruiting
SponsorHoffmann-La Roche
Study typeInterventional
Conditions
Age-related Macular Degeneration
Requirements
From 50 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT04657289
