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A study to test an eye implant that continuously releases ranibizumab, and is refilled either every 6 months or every 9 months in patients with wet age-related macular degeneration (wet AMD) (Velodrome)
A Phase IIIb, global, multicenter, randomized, visual assessor-masked study of the efficacy, safety, and pharmacokinetics of a 36-week refill regim for the Port Delivery System with ranibizumab in patients with neovascular age-related macular degeneration (Velodrome)
- Age-Related Macular Degeneration
Trial Status:
Recruiting
This trial runs in
Cities
- aan
- ABA
- Albury
- Barcelona
- Basel
- Bern
- Binningen
- Bristol
- Bruxelles
- Burjasot
- Busan
- Chieti
- Créteil
- Daegu
- East Melbourne
- Freiburg im Breisgau
- Gent
- Graz
- Haifa
- Hull
- hurstville
- Jerusalem
- Kaohsiung City
- Kefar Sava
- Kocaeli
- Köln
- Lausanne
- Leuven
- Liverpool
- Lombardy
- London
- Ludwigshafen am Rhein
- Lyon
- Madrid
- Majadahonda
- Milano
- München
- Münster
- Nedlands
- negrar-di-valpolicella
- New Taipei City
- Newcastle upon Tyne
- Pamplona
- Paris
- Petah Tikva
- Regensburg
- Rehovot
- Roma
- Rome
- Rosario
- Rowville
- Sant Cugat del Vallès
- Santa Catarina
- Seongnam-si
- Seoul
- Singapore
- South Brisbane
- sulzbach-saar
- Sunderland
- Sydney
- São Paulo
- Taipei City
- Tel Aviv-Yafo
- Tübingen
- Udine
- Ulm
- Valladolid
- Wien
- Wolverhampton
- Zürich
Trial Identifier:
NCT04657289 WR42221
Trial Summary
Study WR42221 is a Phase IIIb, global, multicenter, randomized, visual assessor-masked study designed to assess the efficacy, safety, and pharmacokinetics of the Port Delivery System with ranibizumab (PDS) 100 mg/mL delivered every 36 weeks (Q36W) compared with every 24 weeks (Q24W) in patients with neovascular age-related macular degeneration (nAMD).
Hoffmann-La Roche
Sponsor
Phase 3
Phase
NCT04657289 , WR42221
Trial Identifier
All
Gender
≥50 Years
Age
No
Healthy Volunteers
How does the Velodrome clinical trial work?
This clinical trial is recruiting people who have a type of eye disease called wet age-related macular degeneration (wet AMD) and is testing an investigational (not approved) eye implant known as the Port Delivery System with ranibizumab (PDS). The purpose of this clinical trial is to compare how effective and safe the PDS is when refilled either every 6 months or every 9 months.
How do I take part in this clinical trial?
To be able to participate in this clinical trial, you must:
Aged 50 or over
Have been diagnosed with wet AMD
Have previously been treated with at least three anti-VEGF injections for wet AMD in the past six months or are prepared to have these treatments before joining the study
Have shown response to anti-VEGF treatment before joining the study
If you think this clinical trial may be suitable for you and would like to take part, please talk to your doctor. If your doctor thinks that you might be able to take part in this clinical trial, he/she may refer you to the closest clinical trial doctor. They will give you all the information you need to make your decision about taking part in the clinical trial. You can also find the clinical trial locations on this page.
You will have some further tests to make sure you will be able to take the treatments given in this clinical trial. Some of these tests or procedures may be part of your regular medical care. They may be done even if you do not take part in the clinical trial. If you have had some of the tests recently, they may not need to be done again.
Before starting the clinical trial, you will be told about any risks and benefits of taking part in the trial. You will also be told what other treatments are available so that you may decide if you still want to take part.
While taking part in the clinical trial, women (if you are not currently pregnant but can become pregnant) will need to either not have heterosexual intercourse or take contraceptive medication for safety reasons.
What treatment will I be given if I join this clinical trial?
Everyone who joins this clinical trial will have the Port Delivery System with ranibizumab (PDS) surgically inserted in one eye and be randomly assigned (you will be assigned by chance, like flipping a coin) to one of two groups (treatment arms) at the 6-month visit:
- Arm A: PDS refilled every 9 months (Arm A) for up to 18 months
- Arm B: PDS refilled every 6 months (Arm B) for up to 18 months
You will have a 50% chance of being placed in either group.
How often will I be seen in follow-up appointments, and for how long?
You will be given the clinical trial PDS refills for about 18 months. You are free to stop this treatment at any time. Unless you leave the study early for any reasons, you will have at least 23 clinic visits, which include a screening visit. The purpose of these visits is so that we can monitor your eye and general health and see how you are responding to your treatment. You will generally have study visits every month and you will occasionally receive follow-up calls to check on how you are doing. If you experience any side effects or injury during the study, your study doctor will explain your options and discuss with you a plan for further treatment.
What happens if I am unable to take part in this clinical trial?
If this clinical trial is not suitable for you, you will not be able to take part. Your doctor will suggest other clinical trials that you may be able to take part in or other treatments that you can be given. You will not lose access to any of your regular care.
For more information about this clinical trial see the For Expert tab on the specific ForPatient page or follow this link to ClinicalTrials.gov https://clinicaltrials.gov/ct2/show/NCT04657289
Trial-identifier: NCT04657289
Trial Summary
Study WR42221 is a Phase IIIb, global, multicenter, randomized, visual assessor-masked study designed to assess the efficacy, safety, and pharmacokinetics of the Port Delivery System with ranibizumab (PDS) 100 mg/mL delivered every 36 weeks (Q36W) compared with every 24 weeks (Q24W) in patients with neovascular age-related macular degeneration (nAMD).
Hoffmann-La Roche
Sponsor
Phase 3
Phase
NCT04657289 , WR42221
Trial Identifier
Ranibizumab, Port Delivery System with Ranibizumab
Treatments
Neovascular Age-related Macular Degeneration (nAMD)
Condition
Official Title
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)
Eligibility Criteria
All
Gender
≥50 Years
Age
No
Healthy Volunteers
Inclusion Criteria
- Age ≥ 50 years at time of signing Informed Consent Form
- Initial diagnosis of 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 (approximate 20/200 Snellen equivalent) or better
Exclusion Criteria
- History of vitrectomy surgery, submacular surgery, or other surgical intervention for AMD in study eye
- Prior treatment with Visudyne®, external-beam radiation therapy, or transpupillary thermotherapy in study eye
- Previous treatment with corticosteroid intravitreal injection, intraocular device implantation, previous laser (any type) used for AMD treatment in study eye
- Treatment with anti-VEGF agents other than ranibizumab within 1 month prior to the enrollment visit in study eye
- 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
- Prior treatment with brolucizumab (at any time prior to the screening visit) in either eye
- Prior participation in a clinical trial involving any anti-VEGF drugs, within 6 months prior to the enrollment visit in either eye
- Subretinal hemorrhage that involves the center of the fovea, if the hemorrhage is >0.5 disc area at screening in study eye
- Subfoveal fibrosis or subfoveal atrophy in study eye
- CNV due to other causes, such as ocular histoplasmosis, trauma, central serous chorio-retinopathy, or pathologic myopia in either eye
- Retinal pigment epithelial tear in study eye
- 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 in study eye
- Active intraocular inflammation in study eye
- History of vitreous hemorrhage in study eye
- History of rhegmatogenous retinal detachment in study eye
- History of rhegmatogenous retinal tears or peripheral retinal breaks within 3 months prior to the enrollment visit in study eye
- History of pars plana vitrectomy surgery
- Aphakia or absence of the posterior capsule in study eye
- Spherical equivalent of the refractive error demonstrating more than 8 diopters of myopia in study eye
- Preoperative refractive error that exceeded 8 diopters of myopia, for Participants who have undergone prior refractive or cataract surgery in study eye
- Intraocular surgery within 3 months preceding the enrollment visit in study eye
- Uncontrolled 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 eye
- History of glaucoma-filtering surgery, tube shunts, or microinvasive glaucoma surgery in study eye
- History of corneal transplant in study eye
- Any history of uveitis requiring treatment in either eye
- Active infectious conjunctivitis, keratitis, scleritis, or endophthalmitis in either eye
- Uncontrolled blood pressure
- History of stroke within the last 3 months prior to informed consent
- Atrial fibrillation diagnosed or worsened within the last 3 months prior to 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 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 investigator
- Confirmed active systemic infection
- Use of any systemic anti-VEGF agents
- Active 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 months
- Previous participation in any non-ocular disease studies of investigational drugs within 1 month preceding the informed consent
- Non-functioning non-study eye
For the latest version of this information please go to www.forpatients.roche.com