A clinical trial to look at how an eye implant that continuously releases ranibizumab works to reduce certain signs of wet age-related macular degeneration, how safe the eye implant and ranibizumab are, and how the body gets rid of and responds to ranibizumab

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)

  • Eye Disorder
  • Age-Related Macular Degeneration
  • Neovascular Age-related Macular Degeneration
Please note that the recruitment status of the trial at your site may differ from the overall study status because some study sites may recruit earlier than others.
Trial Status:

Recruiting

This trial runs in
Cities
  • aan
  • Albury
  • Ankara
  • Barcelona
  • Basel
  • Bern
  • Binningen
  • blagny-sur-vingeanne
  • Bonn
  • Bordeaux
  • Bristol
  • Bruxelles
  • Buenos Aires
  • burjassot
  • Busan
  • Changhua County
  • Chieti
  • Cottbus
  • Créteil
  • Daegu
  • East Melbourne
  • Frankfurt am Main
  • Freiburg im Breisgau
  • Gent
  • Goiás
  • Graz
  • Haifa
  • Hamburg
  • Hull
  • hurstville
  • Incheon
  • İstanbul
  • Jerusalem
  • Kaohsiung City
  • Kefar Sava
  • Kocaeli
  • Köln
  • L'Hospitalet de Llobregat
  • Lausanne
  • Leuven
  • Liverpool
  • Lombardia
  • Lombardy
  • London
  • Ludwigshafen am Rhein
  • luik
  • Luzern
  • Lyon
  • Madrid
  • Majadahonda
  • Manchester
  • Marseille
  • Milano
  • Minas Gerais
  • München
  • Münster
  • Nedlands
  • negrar-di-valpolicella
  • Newcastle upon Tyne
  • Pamplona
  • Paris
  • Petah Tikva
  • Regensburg
  • Rehovot
  • Rio de Janeiro
  • Roma
  • Rosario
  • Rowville
  • Sant Cugat del Vallès
  • Santa Catarina
  • Seongnam-si
  • Seoul
  • Singapore
  • sulzbach-saar
  • Sunderland
  • Sydney
  • São Paulo
  • Taipei City
  • Taoyuan City
  • Tel Aviv-Yafo
  • Tübingen
  • Udine
  • Ulm
  • Valladolid
  • Wien
  • Wolverhampton
  • Woolloongabba
  • Zürich
Trial Identifier:

NCT04657289 2023-507130-24-00 WR42221

      Show trial locations

      The source of the below information is public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc.. It has been summarised and edited into simpler language. For more information about this clinical trial see the For Expert tab on the specific ForPatients page or follow these links to https://clinicaltrials.gov and/or https://euclinicaltrials.eu and/or https://www.isrctn.com.

      The below information is taken directly from public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc., and has not been edited.

      Results Disclaimer

      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, 2023-507130-24-00 Trial Identifier
      All Gender
      ≥50 Years Age
      No Healthy Volunteers

      1. Why is the Velodrome clinical trial needed?

      Wet age-related macular degeneration (AMD) causes blurred or worse vision in one or both eyes. In wet AMD, a protein called VEGF makes abnormal blood vessels form in the central retina (‘macula’), which can leak fluid and affect central vision. Wet AMD can be treated by injecting an anti-VEGF drug (e.g. ranibizumab) into the eye, and can be given up to every 1-2 months. Many people find this a burden. The Port Delivery System (PDS) is a refillable eye implant device that releases ranibizumab into the eye continuously over time. The PDS can remain in the eye long-term unless removed for health reasons. This clinical trial aims to assess the effects, good or bad, of ranibizumab delivered by the PDS, in people with wet AMD. It will be refilled either every 6 months or 9 months.

      2. How does the Velodrome clinical trial work?

      People can take part if they were diagnosed with wet AMD within the last 9 months, have previously been treated with at least three anti-VEGF injections within the last 6 months, and responded to anti-VEGF treatment before the trial. People not yet treated with anti-VEGF injections can still take part. 

      The clinical trial is in two phases. People taking part (participants) will be given the clinical trial treatment ranibizumab with the PDS eye implant. The PDS will be surgically inserted into the affected eye on Day 1 of the first phase. After 6 months, participants who didn’t need extra eye injections of ranibizumab (at 4 and/or 5 months after first being given the PDS), or their wet AMD activity meets certain criteria at 6 months, can join the second phase. The second phase will last 12 months, and during this, participants will be given either two PDS ranibizumab refills (every 6 months) or one refill at 9 months after the start of the trial. 

      Participants will see the clinical trial doctor every month. Hospital visits include eye and general health checks, the participant’s treatment response, and any side effects they may have. Participants will occasionally receive follow-up calls to check on their health. The total time of trial participation will be about 1.5 years. Participants can stop trial treatment and leave the clinical trial at any time. At the end, participants can decide with the clinical trial doctor to continue having PDS ranibizumab refills in an extension of this trial (called Portal). If they do not continue, participants can choose to have the PDS removed or leave it in their eye long-term.

      3. What are the main endpoints of the Velodrome clinical trial?

      The main clinical trial endpoint (the main result measured in the trial to see if the drug and device have worked) is the average change in the best eyesight a person can have when wearing glasses or contact lenses – known as ‘best corrected vision’ – at 15 and 16 months compared with the start of the trial. 

      The other clinical trial endpoints include:

      • The change in vision test score and thickness of the back of the eye over the whole trial
      • The number of participants with very good or poor best-corrected vision scores
      • The number of participants who prefer treatment with the PDS compared with eye injections
      • The number of participants who do not need ranibizumab eye injections at 4 and/or 5 months
      • The number and seriousness of any side effects

      4. Who can take part in this clinical trial?

      People aged over 50, with at least 20/200 best-corrected vision and no scarring caused by wet AMD can take part. Participants' eyes must be clear enough so photo’s of the back of their eyes can be taken. Their vision must be tested before having anti-VEGF treatment. 

      People may not take part if they have had some treatments for wet AMD before (not including some anti-VEGF treatment), or if they were involved in another wet AMD clinical trial. People who had eye surgery or implants or a recent history of conditions like stroke, heart problems, or cancer, and people who are pregnant or breastfeeding cannot take part. This applies during the clinical trial and 1 year after.

      5. What treatment will participants be given in this clinical trial?

      Everyone in this clinical trial will have the PDS with ranibizumab surgically inserted into one eye under anaesthetic, on Day 1 of the trial. In the second phase, some participants will be split into two groups randomly (like flipping a coin) and given either:

      • Group 1: one PDS ranibizumab refill at 9 months from the start of the trial
      • Group 2: two PDS ranibizumab refills at 6 and 12 months from the start of the trial

      Participants have a 1 in 2 chance of being placed in either group. The second phase only includes those who did not need eye injections of ranibizumab at 4 and/or 5 months. Or, their wet AMD activity meets certain criteria at 6 months.

      6. Are there any risks or benefits in taking part in this clinical trial?

      The safety or effectiveness of the experimental treatment may not be fully known at the time of the trial. Most trials involve some risks to the participant. However, it may not be greater than the risks related to routine medical care or the natural progression of the health condition. People who would like to participate will be told about any risks and benefits of taking part, as well as other procedures, tests, or assessments in the trial. All these will be described in an informed consent (a document that provides people with the information they need to decide to volunteer for the trial). 

      Risks associated with the clinical trial drugs, devices, or procedures

      Participants may have side effects from the drugs, devices, or procedures used in this clinical trial. Side effects can be mild to severe, even life-threatening, and vary from person to person. Participants will be closely monitored during the clinical trial; safety assessments are performed regularly. Participants will be told about the known side effects of ranibizumab and the PDS, the surgical eye implant and PDS refill procedures and injections into the eye, and possible side effects based on human and laboratory studies or knowledge of similar drugs, devices and procedures. 

      Potential benefits associated with the clinical trial

      Participants' health may or may not improve from participation in the clinical trial. Still, the information collected may help other people with similar medical conditions in the future.

      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, 2023-507130-24-00 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

      About Clinical Research

      What is a clinical trial? Why should I consider taking part in a clinical trial? And why does Genentech conduct clinical trials?

      Find out now