AI Cure is a research tool showing open data. Not medical advice. Discuss with your doctor. Terms

โ† Trials
๐Ÿงช

Extension Study for the Port Delivery System With Ranibizumab (Portal)

RecruitingPhase 3Ages 50 Years - anyAllHoffmann-La Roche
๐Ÿ’ฌ

In plain words

What the trial is, and whether it could suit you

This study will evaluate the long-term safety and tolerability of the Port Delivery System with ranibizumab (PDS) (100 mg/mL) in participants with neovascular age-related macular degeneration (nAMD) who have either completed Phase II Study GX28228 (Ladder), Phase III Study GR40548 (Archway), Phase IIIb Study WR42221 (Velodrome), or completed Week 24 visit in Study WR42221 but were not eligible to be randomized in WR42221.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * 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 assessments * For women of childbearing potential: agreement to remain abstinent or use contraceptive measures Exclusion Criteria: * 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 ranibizumab * History 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 complications * History 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 complications * Requirement for continuous use of any medications or treatments indicated in the "Prohibited Therapy" Sub-study 1 Inclusion Criteria \- For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures Participants must meet the following ocular criteria for the study eye for substudy entry: * Diagnosis of exudative nAMD within 2 years prior to the enrollment visit * Previous treatment with at least two anti-VEGF ITV injections (e.g., ranibizumab, bevacizumab, or aflibercept) for nAMD per standard of care within 6 months prior to the enrollment visit * Demonstrated response to prior anti-VEGF ITV treatment since diagnosis, as evidenced at enrollment by the following: Overall decrease in nAMD disease activity detected on SD-OCT AND Stable or improved best-corrected visual acuity (BCVA) * All subtypes of nAMD lesions are permissible (i.e., type I, type II, type III, or mixed forms per optical coherence tomography (OCT) classification) 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 FP and SD-OCT images. Exclusion Criteria Prior Ocular Treatments 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 ITV injection * Previous intraocular device implantation * Previous laser (any type) used for AMD treatment Either Eye * Treatment with anti-VEGF agents other than ranibizumab within 1 month prior to the enrollment visit * Prior participation in a clinical trial involving anti-VEGF drugs within 6 months prior to the enrollment visit, other than ranibizumab CNV 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 screening * Subfoveal fibrosis or subfoveal atrophy Either Eye \- CNV due to other causes, such as ocular histoplasmosis, trauma, or pathologic myopia Concurrent Ocular Conditions Study Eye * Retinal pigment epithelial tear * 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 results * Active intraocular inflammation (grade trace or above) * History of vitreous hemorrhage * History of rhegmatogenous retinal detachment * History of rhegmatogenous retinal tears or peripheral retinal breaks within 3 months prior to the enrollment visit * Aphakia or absence of the posterior capsule * 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. * Spherical equivalent of the refractive error demonstrating more than 8 diopters of myopia * Preoperative refractive error that exceeds 8 diopters of myopia, for participants who have undergone prior refractive or cataract surgery in the study eye * Intraocular surgery (including cataract surgery) within 3 months 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 * History of prior vitrectomy surgery and absence of posterior capsule Either Eye * History of idiopathic or autoimmune-associated uveitis * Active infectious conjunctivitis, keratitis, scleritis, or endophthalmitis Concurrent Systemic Conditions * Inability to comply with study schedule or procedures as described in the study protocol * Uncontrolled blood pressure * History of stroke within the last 3 months prior to informed consent * Uncontrolled atrial fibrillation within 3 months of informed consent * History 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 plac
๐Ÿ’Š

What it tests

  • PDS Implant with Ranibizumab 100 mg/mL
๐Ÿ“

Where

165 sites
Retinal Research Institute, LLC
Phoenix, United States
Arizona Retina and Vitreous Consultants
Phoenix, United States
Barnet Dulaney Perkins Eye Center
Phoenix, United States
Associated Retina Consultants
Phoenix, United States
Retinal Consultants of Arizona
Phoenix, United States
California Retina Consultants
Bakersfield, United States
Retina-Vitreous Associates Medical Group
Beverly Hills, United States
The Retina Partners
Encino, United States

โ€ฆand 157 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
๐Ÿ›ก๏ธ

AI Cure shows public evidence (Open Targets, ClinicalTrials.gov, PubMed, openFDA, DepMap, AlphaFold) with its source, and AI summaries that cite it โ€” not medical advice and not a cure. Treatment decisions belong with your doctor. Research ideas are shared only with approved researchers and labs, who can test them. In an emergency call your local emergency number (112 in India and Europe, 911 in the US). AI Cure Terms of Use ยท Privacy