A clinical trial to compare the experimental treatment faricimab with the approved medicine aflibercept in people with macular oedema due to blockage of at least one branch of the retinal blood vessels within the eye

A Study to Evaluate the Efficacy and Safety of Faricimab in Participants With Macular Edema Secondary to Branch Retinal Vein Occlusion

  • Eye Disorder
  • Retinal Vein Occlusion
  • Macular Edema
  • Branch Retinal Vein Occlusion
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:

Completed

This trial runs in
Countries
  • Argentina
  • Australia
  • Austria
  • Brazil
  • China
  • Czechia
  • France
  • Germany
  • Hong Kong
  • Hungary
  • Israel
  • Italy
  • Japan
  • Poland
  • Portugal
  • Russia
  • Singapore
  • South Korea
  • Spain
  • Taiwan
  • United Kingdom
  • United States
Trial Identifier:

NCT04740905 2020-000440-63 GR41984

      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

      This is a Phase III, multicenter, randomized, double-masked, active comparator-controlled, parallel-group study evaluating the efficacy, safety, and pharmacokinetics of faricimab administered by intravitreal (IVT) injection at 4-week intervals until Week 24, followed by a double-masked period of study without active control to evaluate faricimab administered according to a personalized treatment interval (PTI) dosing regimen in participants with macular edema due to branch retinal vein occlusion (BRVO).

      Hoffmann-La Roche Sponsor
      Phase 3 Phase
      NCT04740905, GR41984, 2020-000440-63 Trial Identifier
      All Gender
      ≥18 Years Age
      No Healthy Volunteers

      How does the BALATON clinical trial work?

      This clinical trial is recruiting people who have macular oedema (swelling within the macula part of the eye) that is caused by branch retinal vein occlusion (BRVO). BRVO is a blockage in at least one branch of the retinal veins within the eye, which causes fluid to leak into the macula. This build-up of fluid causes swelling that can affect vision.

      The purpose of this clinical trial is to compare the effects, good or bad, of faricimab against aflibercept in patients with macular oedema due to BRVO. If you take part in this clinical trial, you will receive either faricimab or aflibercept for the first 20 weeks, followed by faricimab for a further 48 weeks.

      Faricimab blocks the two important pathways that are thought to be involved in BRVO: vascular endothelial growth factor (VEGF) and angiopoietin-2 (Ang-2). Aflibercept blocks VEGF only. 

       

      How do I take part in this clinical trial?

      To be able to take part in this clinical trial, you must be at least 18 years old and have been diagnosed with macular oedema due to BRVO for no more than 4 months. Your eyesight and eye health will also be checked before you take part.

      You must not have uncontrolled high blood pressure or any other eye-related problems. If you have other conditions or have previously received some other treatments, you may not be able to take part.

      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, both men and 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 to join this clinical trial? 

      This clinical trial is split into two parts. In Part 1, everyone who joins this clinical trial will be split into two groups randomly (like flipping a coin) and given either:

      • Faricimab as an injection into the study eye every four weeks for 20 weeks (a total of 6 injections)
      • OR aflibercept as an injection into the study eye every four weeks for 20 weeks (a total of 6 injections) 

      You will have a 1 in 2 chance of being placed in either group. 

      In Part 2, you will receive faricimab treatment, even if you received aflibercept in Part 1. You will receive faricimab as an injection into the study eye every 4, 8, 12 or 16 weeks, depending on the condition of your eye. You will continue to have study visits every four weeks, but if faricimab injections are not scheduled at this time, you will have a “sham” treatment designed to feel like a real injection (an empty syringe without a needle will be pressed against your numbed eye instead). 

      Neither you nor your clinical trial doctor can choose or know the group you are in during Part 1 or how often you receive faricimab treatment during Part 2. However, your clinical trial doctor can find out which group you are in, if your safety is at risk. 

       

      How often will I be seen in follow-up appointments and for how long?

      In Part 1 of this clinical trial, you will be given the clinical trial treatment faricimab or aflibercept for 20 weeks. After this, in Part 2, you will be given faricimab for a further 48 weeks. You are free to stop this treatment at any time. 

      While being given treatment, you will still be seen regularly by the clinical trial doctor. These hospital visits will include checks to see how you are responding to the treatment and to monitor any side effects that you may be having. 

       

      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

      Trial-identifier: NCT04740905

      Trial Summary

      This is a Phase III, multicenter, randomized, double-masked, active comparator-controlled, parallel-group study evaluating the efficacy, safety, and pharmacokinetics of faricimab administered by intravitreal (IVT) injection at 4-week intervals until Week 24, followed by a double-masked period of study without active control to evaluate faricimab administered according to a personalized treatment interval (PTI) dosing regimen in participants with macular edema due to branch retinal vein occlusion (BRVO).

      Hoffmann-La Roche Sponsor
      Phase 3 Phase
      NCT04740905, GR41984, 2020-000440-63 Trial Identifier
      Faricimab, Aflibercept, Sham Procedure Treatments
      Macular Edema, Branch Retinal Vein Occlusion Condition
      Official Title

      A Phase III, Multicenter, Randomized, Double-Masked, Active Comparator-Controlled Study to Evaluate the Efficacy and Safety of Faricimab in Patients With Macular Edema Secondary to Branch Retinal Vein Occlusion

      Eligibility Criteria

      All Gender
      ≥18 Years Age
      No Healthy Volunteers
      Inclusion Criteria
      • Foveal center-involved macular edema due to branch retinal vein occlusion (BRVO), diagnosed no longer than 4 months prior to the screening visit
      • Best-corrected visual acuity (BCVA) of 73 to 19 letters, inclusive (20/40 to 20/400 approximate Snellen equivalent) on Day 1
      • Sufficiently clear ocular media and adequate pupillary dilatation to allow acquisition of good quality retinal images to confirm diagnosis
      • For women of childbearing potential: agreement to remain abstinent or use contraception, and agreement to refrain from donating eggs during the treatment period and for 3 months after the final dose of study treatment
      Exclusion Criteria
      • Any major illness or major surgical procedure within 1 month before screening
      • Uncontrolled blood pressure
      • Stroke (cerebral vascular accident) or myocardial infarction within 6 months prior to Day 1
      • Pregnant or breastfeeding, or intending to become pregnant during the study

      Ocular Exclusion Criteria for Study Eye:

      • History of previous episodes of macular edema due to RVO or persistent macular edema due to RVO diagnosed more than 4 months before screening
      • Any current ocular condition which, in the opinion of the investigator, is currently causing or could be expected to contribute to irreversible vision loss due to a cause other than macular edema due to RVO in the study eye (e.g., ischemic maculopathy, Irvine-Gass syndrome, foveal atrophy, foveal fibrosis, pigment abnormalities, dense subfoveal hard exudates, or other non-retinal conditions)
      • Macular laser (focal/grid) in the study eye at any time prior to Day 1
      • Panretinal photocoagulation in the study eye within 3 months prior to Day 1 or anticipated within 3 months of study start on Day 1
      • Any prior or current treatment for macular edema; macular neovascularization, including diabetic macular edema (DME) and neovascular age-related macular degeneration (nAMD); and vitreomacular-interface abnormalities, including, but not restricted to, IVT treatment with anti-VEGF, steroids, tissue plasminogen activator, ocriplasmin, C3F8, air or periocular injection
      • Any prior intervention with verteporfin photodynamic therapy, diode laser, transpupillary thermotherapy, or vitreo-retinal surgery including sheatotomy
      • Any prior steroid implant use including dexamethasone intravitreal implant (Ozurdex) and fluocinolone acetonide intravitreal implant (Iluvien)

      Ocular Exclusion Criteria for Both Eyes:

      • Prior IVT administration of faricimab in either eye
      • History of idiopathic or autoimmune-associated uveitis in either eye
      • Active periocular, ocular or intraocular inflammation or infection (including suspected) in either eye on Day 1

      For the latest version of this information please go to www.forpatients.roche.com

       

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