Last updated 12 days ago
Extension Study for the Port Delivery System With Ranibizumab (Portal)
1000 patients around the world
Available in Argentina, United States
The Transscleral Photocoagulation sub-study (sub-study 1) will evaluate the effectiveness
of using transscleral photocoagulation (TPC) with the Iridex laser system to mitigate
vitreous hemorrhages secondary to the Port Delivery System with ranibizumab (PDS)
implantation procedure in participants with neovascular age-related macular degeneration
(nAMD). The sub-study will enroll about 55 participants.
The Re-implantation sub-study (sub-study 2) will evaluate the safety of re-implantation
with the updated PDS with ranibizumab . Up to 100 participants who previously
participated in the main study in the United States will be enrolled and followed for a
maximum of 72 weeks post-re-implantation in the substudy.
Hoffmann-La Roche
1Research sites
1000Patients around the world
Requirements for the patient
From 50 Years
All Gender
Medical requirements
- Previous enrollment in and completion of Study GX28228 (Ladder) or Study GR40548 (Archway), without early treatment or study discontinuation in either study OR Previous enrollment in Study WR42221 (Velodrome) and either not eligible to be randomized in Study WR42221 at Week 24 or completed the study (from the Q24W or Q36W arm)Ability and willingness to undertake all scheduled visits and assessmentsFor women of childbearing potential: agreement to remain abstinent or use contraceptive measuresFor women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measuresPatients must meet the following ocular criteria for the study eye for substudy entry:
- Pregnant or breastfeeding, or intending to become pregnant during the treatment period and for at least 28 days after the last intravitreal injection of ranibizumab or 1 year after the last Implant refill-exchange of ranibizumabHistory of other ocular diseases that give reasonable suspicion of a disease or condition that contraindicates the use of ranibizumab, that might affect interpretation of the results of the study or that renders the participant at high risk for treatment complicationsHistory of other diseases, 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 that renders the participant at high risk of treatment complicationsRequirement for continuous use of any medications or treatments indicated in the "Prohibited Therapy"Prior Ocular Treatments Study Eye: History of vitrectomy surgery, submacular surgery, or other surgical intervention for AMDPrior Ocular Treatments Study Eye: Prior treatment with Visudyne, external-beam radiation therapy, or transpupillary thermotherapyPrior Ocular Treatments Study Eye: Previous treatment with corticosteroid ITV injectionPrior Ocular Treatments Study Eye: Previous intraocular device implantationPrior Ocular Treatments Study Eye: Previous laser (any type) used for AMD treatmentEither Eye: Treatment with anti-VEGF agents other than ranibizumab within 1 month prior to the enrollment visitEither Eye: Prior participation in a clinical trial involving anti-VEGF drugs within 6 months prior to the enrollment visit, other than ranibizumabCNV Lesion Charateristics Study Eye: Subretinal hemorrhage that involves the center of the fovea, if the hemorrhage is greater than 0.5 disc area (1.27 mm2 ) in size at screeningCNV Lesion Charateristics Study Eye: Subfoveal fibrosis or subfoveal atrophyEither Eye: CNV due to other causes, such as ocular histoplasmosis, trauma, or pathologic myopiaConcurrent Ocular Conditions Study Eye: Retinal pigment epithelial tearConcurrent Ocular Conditions Study Eye: Any concurrent intraocular condition (e.g., cataract, glaucoma, diabetic retinopathy, or epiretinal membrane) 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 resultsConcurrent Ocular Conditions Study Eye: Active intraocular inflammation (grade trace or above)Concurrent Ocular Conditions Study Eye: History of vitreous hemorrhageConcurrent Ocular Conditions Study Eye: History of rhegmatogenous retinal detachmentConcurrent Ocular Conditions Study Eye: History of rhegmatogenous retinal tears or peripheral retinal breaks within 3 months prior to the enrollment visitConcurrent Ocular Conditions Study Eye: Aphakia or absence of the posterior capsuleConcurrent Ocular Conditions Study Eye: Previous violation of the posterior capsule is also an exclusion criterion unless it occurred as a result of yttrium-aluminum garnet (YAG) laser posterior capsulotomy in association with prior, posterior chamber intraocular lens implantation.Concurrent Ocular Conditions Study Eye: Spherical equivalent of the refractive error demonstrating more than 8 diopters of myopiaConcurrent Ocular Conditions Study Eye: Preoperative refractive error that exceeds 8 diopters of myopia, for patients who have undergone prior refractive or cataract surgery in the study eyeConcurrent Ocular Conditions Study Eye: Intraocular surgery (including cataract surgery) within 3 months preceding the enrollment visitConcurrent Ocular Conditions Study Eye: 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 studyConcurrent Ocular Conditions Study Eye: History of glaucoma-filtering surgery, tube shunts, or microinvasive glaucoma surgeryConcurrent Ocular Conditions Study Eye: History of corneal transplantConcurrent Ocular Conditions Study Eye: History of prior vitrectomy surgery and absence of posterior capsuleEither Eye: History of idiopathic or autoimmune-associated uveitisEither Eye: Active infectious conjunctivitis, keratitis, scleritis, or endophthalmitisConcurrent Systemic Conditions: Inability to comply with study schedule or procedures as described in the study protocolConcurrent Systemic Conditions: Uncontrolled blood pressureConcurrent Systemic Conditions: History of stroke within the last 3 months prior to informed consentConcurrent Systemic Conditions: Uncontrolled atrial fibrillation within 3 months of informed consentConcurrent Systemic Conditions: History of myocardial infarction within the last 3 months prior to informed consentConcurrent Systemic Conditions: 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 patient at high risk of treatment complications in the opinion of the investigatorConcurrent Systemic Conditions: Current systemic treatment for a confirmed active systemic infectionConcurrent Systemic Conditions: Use of any systemic anti-VEGF agentsConcurrent Systemic Conditions: Chronic use of oral corticosteroidsConcurrent Systemic Conditions: Active cancer within 12 months of enrollmentConcurrent Systemic Conditions: Previous participation in any non-ocular (systemic) disease studies of investigational drugs within 1 month preceding the informed consent (excluding vitamins and minerals)Concurrent Systemic Conditions: Use of antimitotic or antimetabolite therapy within 30 days or 5 elimination half-lives of the enrollment visitConcurrent Systemic Conditions: History of albinismConcurrent Systemic Conditions: Pregnant or breastfeeding, or intending to become pregnant during the treatment period and for at least 28 days after the last ITV injection of ranibizumab or 1 year after the last implant refill-exchange of ranibizumab
Sites
Instituto Oftalmológico de Buenos Aires / Oftalmos
Recruiting
StudyPortal
SponsorHoffmann-La Roche
Study typeInterventional
Requirements
From 50 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT03683251
