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Trial record 1 of 1 for:    GR41984
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A Study to Evaluate the Efficacy and Safety of Faricimab in Participants With Macular Edema Secondary to Branch Retinal Vein Occlusion (BALATON)

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ClinicalTrials.gov Identifier: NCT04740905
Recruitment Status : Completed
First Posted : February 5, 2021
Last Update Posted : July 13, 2023
Sponsor:
Collaborator:
Chugai Pharmaceutical
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Description
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Brief 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).

Condition or disease Intervention/treatment Phase
Macular Edema Branch Retinal Vein Occlusion Drug: Faricimab Drug: Aflibercept Procedure: Sham Procedure Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 553 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : March 2, 2021
Actual Primary Completion Date : July 6, 2022
Actual Study Completion Date : June 12, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema

Arms and Interventions
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Arm Intervention/treatment
Experimental: Arm A: Faricimab Q4W (Part 1), Faricimab PTI (Part 2)
In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm A will receive faricimab 6 milligrams (mg) by IVT injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections). In Part 2 (from Week 24 to Week 72), participants will receive faricimab 6 mg by IVT injection according to a personalized treatment interval (PTI) dosing regimen. To preserve masking for Part 2, a sham procedure will be administered during study visits at which no faricimab treatment is administered (according to the PTI dosing regimen).
 Drug: Faricimab
Faricimab will be administered by intravitreal (IVT) injection as specified in each treatment arm.
Other Names:
  • VABYSMO®
  • faricimab-svoa
  • RO6867461
  • RG7716

Procedure: Sham Procedure
The sham is a procedure that mimics an intravitreal (IVT) injection, but involves the blunt end of an empty syringe (without a needle) being pressed against the anesthetized eye. It will be administered to participants in both treatments arms at applicable visits to maintain masking.
Active Comparator: Arm B: Aflibercept Q4W (Part 1), Faricimab PTI (Part 2)
In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm B will receive aflibercept 2 milligrams (mg) by IVT injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections). In Part 2 (from Week 24 to Week 72), participants will receive faricimab 6 mg by IVT injection according to a personalized treatment interval (PTI) dosing regimen. To preserve masking for Part 2, a sham procedure will be administered during study visits at which no faricimab treatment is administered (according to the PTI dosing regimen).
 Drug: Faricimab
Faricimab will be administered by intravitreal (IVT) injection as specified in each treatment arm.
Other Names:
  • VABYSMO®
  • faricimab-svoa
  • RO6867461
  • RG7716

Drug: Aflibercept
Aflibercept 2 mg will be administered by IVT injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections).
Other Name: Eylea

Procedure: Sham Procedure
The sham is a procedure that mimics an intravitreal (IVT) injection, but involves the blunt end of an empty syringe (without a needle) being pressed against the anesthetized eye. It will be administered to participants in both treatments arms at applicable visits to maintain masking.


Outcome Measures
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Primary Outcome Measures :
  1. Part 1: Change from Baseline in Best-Corrected Visual Acuity (BCVA) at Week 24 [ Time Frame: From Baseline to Week 24 ]

Secondary Outcome Measures :
  1. Part 1: Change from Baseline in BCVA at Specified Timepoints Through Week 24 [ Time Frame: Baseline, Weeks 4, 8, 12, 16, 20, and 24 ]
  2. Part 1: Percentage of Participants Gaining ≥15 Letters in BCVA from Baseline at Week 24 [ Time Frame: Baseline and Week 24 ]
  3. Part 1: Percentage of Participants Gaining ≥15 Letters in BCVA from Baseline at Specified Timepoints Through Week 24 [ Time Frame: Baseline, Weeks 4, 8, 12, 16, 20, and 24 ]
  4. Part 1: Percentage of Participants Gaining ≥10 Letters in BCVA from Baseline at Specified Timepoints Through Week 24 [ Time Frame: Baseline, Weeks 4, 8, 12, 16, 20, and 24 ]
  5. Part 1: Percentage of Participants Gaining ≥5 Letters in BCVA from Baseline at Specified Timepoints Through Week 24 [ Time Frame: Baseline, Weeks 4, 8, 12, 16, 20, and 24 ]
  6. Part 1: Percentage of Participants Gaining >0 Letters in BCVA from Baseline at Specified Timepoints Through Week 24 [ Time Frame: Baseline, Weeks 4, 8, 12, 16, 20, and 24 ]
  7. Part 1: Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA from Baseline at Specified Timepoints Through Week 24 [ Time Frame: Baseline, Weeks 4, 8, 12, 16, 20, and 24 ]
  8. Part 1: Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA from Baseline at Specified Timepoints Through Week 24 [ Time Frame: Baseline, Weeks 4, 8, 12, 16, 20, and 24 ]
  9. Part 1: Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA from Baseline at Specified Timepoints Through Week 24 [ Time Frame: Baseline, Weeks 4, 8, 12, 16, 20, and 24 ]
  10. Part 1: Percentage of Participants Achieving ≥84 Letters (20/20 Snellen Equivalent) in BCVA at Specified Timepoints Through Week 24 [ Time Frame: Baseline, Weeks 4, 8, 12, 16, 20, and 24 ]
  11. Part 1: Percentage of Participants Achieving ≥69 Letters (20/40 or Better Snellen Equivalent) in BCVA at Specified Timepoints Through Week 24 [ Time Frame: Baseline, Weeks 4, 8, 12, 16, 20, and 24 ]
  12. Part 1: Percentage of Participants with ≤38 Letters (20/200 or Worse Snellen Equivalent) in BCVA at Specified Timepoints Through Week 24 [ Time Frame: Baseline, Weeks 4, 8, 12, 16, 20, and 24 ]
  13. Part 1: Change from Baseline in Central Subfield Thickness at Specified Timepoints Through Week 24 [ Time Frame: Baseline, Weeks 4, 8, 12, 16, 20, and 24 ]
  14. Part 1: Percentage of Participants with Absence of Macular Edema at Specified Timepoints Through Week 24 [ Time Frame: Baseline, Weeks 4, 8, 12, 16, 20, and 24 ]
  15. Part 1: Percentage of Participants with Absence of Intraretinal Fluid in the Study Eye at Specified Timepoints Through Week 24 [ Time Frame: Baseline, Weeks 4, 8, 12, 16, 20, and 24 ]
  16. Part 1: Percentage of Participants with Absence of Subretinal Fluid in the Study Eye at Specified Timepoints Through Week 24 [ Time Frame: Baseline, Weeks 4, 8, 12, 16, 20, and 24 ]
  17. Part 1: Percentage of Participants with Absence of Intraretinal Fluid and Subretinal Fluid in the Study Eye at Specified Timepoints Through Week 24 [ Time Frame: Baseline, Weeks 4, 8, 12, 16, 20, and 24 ]
  18. Part 1: Change from Baseline in National Eye Institute 25-Item Visual Functioning Questionnaire (NEI VFQ-25) Composite Score at Week 24 [ Time Frame: Baseline and Week 24 ]
  19. Parts 1 and 2: Change from Baseline in BCVA at Specified Timepoints Through Week 72 [ Time Frame: Baseline and every 4 weeks from Week 4 to Week 72 ]
  20. Parts 1 and 2: Percentage of Participants Gaining ≥15 Letters in BCVA from Baseline at Specified Timepoints Through Week 72 [ Time Frame: Baseline and every 4 weeks from Week 4 to Week 72 ]
  21. Parts 1 and 2: Percentage of Participants Gaining ≥10 Letters in BCVA from Baseline at Specified Timepoints Through Week 72 [ Time Frame: Baseline and every 4 weeks from Week 4 to Week 72 ]
  22. Parts 1 and 2: Percentage of Participants Gaining ≥5 Letters in BCVA from Baseline at Specified Timepoints Through Week 72 [ Time Frame: Baseline and every 4 weeks from Week 4 to Week 72 ]
  23. Parts 1 and 2: Percentage of Participants Gaining >0 Letters in BCVA from Baseline at Specified Timepoints Through Week 72 [ Time Frame: Baseline and every 4 weeks from Week 4 to Week 72 ]
  24. Parts 1 and 2: Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA from Baseline at Specified Timepoints Through Week 72 [ Time Frame: Baseline and every 4 weeks from Week 4 to Week 72 ]
  25. Parts 1 and 2: Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA from Baseline at Specified Timepoints Through Week 72 [ Time Frame: Baseline and every 4 weeks from Week 4 to Week 72 ]
  26. Parts 1 and 2: Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA from Baseline at Specified Timepoints Through Week 72 [ Time Frame: Baseline and every 4 weeks from Week 4 to Week 72 ]
  27. Parts 1 and 2: Percentage of Participants Achieving ≥84 Letters (20/20 Snellen Equivalent) in BCVA at Specified Timepoints Through Week 72 [ Time Frame: Every 4 weeks from Week 4 to Week 72 ]
  28. Parts 1 and 2: Percentage of Participants Achieving ≥69 Letters (20/40 or Better Snellen Equivalent) in BCVA at Specified Timepoints Through Week 72 [ Time Frame: Every 4 weeks from Week 4 to Week 72 ]
  29. Parts 1 and 2: Percentage of Participants with ≤38 Letters (20/200 or Worse Snellen Equivalent) in BCVA at Specified Timepoints Through Week 72 [ Time Frame: Every 4 weeks from Week 4 to Week 72 ]
  30. Parts 1 and 2: Change from Baseline in NEI VFQ-25 Questionnaire Composite Score at Specified Timepoints Through Week 72 [ Time Frame: Baseline, Weeks 24, 48, and 72 ]
  31. Parts 1 and 2: Change from Baseline in Central Subfield Thickness at Specified Timepoints Through Week 72 [ Time Frame: Baseline and every 4 weeks from Week 4 to Week 72 ]
  32. Parts 1 and 2: Percentage of Participants with Absence of Macular Edema at Specified Timepoints Through Week 72 [ Time Frame: Baseline and every 4 weeks from Week 4 to Week 72 ]
  33. Parts 1 and 2: Percentage of Participants with Absence of Intraretinal Fluid at Specified Timepoints Through Week 72 [ Time Frame: Baseline and every 4 weeks from Week 4 to Week 72 ]
  34. Parts 1 and 2: Percentage of Participants with Absence of Subretinal Fluid at Specified Timepoints Through Week 72 [ Time Frame: Baseline and every 4 weeks from Week 4 to Week 72 ]
  35. Parts 1 and 2: Percentage of Participants with Absence of Intraretinal Fluid and Subretinal Fluid at Specified Timepoints Through Week 72 [ Time Frame: Baseline and every 4 weeks from Week 4 to Week 72 ]
  36. Part 2: Change from Week 24 in BCVA at Specified Timepoints Through Week 72 [ Time Frame: Every 4 weeks from Week 24 to Week 72 ]
  37. Part 2: Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA from Week 24 at Specified Timepoints Through Week 72 [ Time Frame: Every 4 weeks from Week 24 to Week 72 ]
  38. Part 2: Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA from Week 24 at Specified Timepoints Through Week 72 [ Time Frame: Every 4 weeks from Week 24 to Week 72 ]
  39. Part 2: Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA from Week 24 at Specified Timepoints Through Week 72 [ Time Frame: Every 4 weeks from Week 24 to Week 72 ]
  40. Part 2: Percentage of Participants Avoiding a Loss of >0 Letters in BCVA from Week 24 at Specified Timepoints Through Week 72 [ Time Frame: Every 4 weeks from Week 24 to Week 72 ]
  41. Part 2: Percentage of Participants on Different Treatment Intervals at Week 68 [ Time Frame: Week 68 ]
  42. Part 2: Number of Study Drug Injections Received from Week 24 Through Week 72 [ Time Frame: From Week 24 to Week 72 ]
  43. Incidence and Severity of Ocular Adverse Events, with Severity Determined According to Adverse Event Severity Grading Scale [ Time Frame: From Baseline until end of study (up to 72 weeks) ]
  44. Incidence and Severity of Non-Ocular Adverse Events, with Severity Determined According to Adverse Event Severity Grading Scale [ Time Frame: From Baseline until end of study (up to 72 weeks) ]
  45. Plasma Concentration of Faricimab Over Time [ Time Frame: Predose at Day 1, Weeks 4, 24, 28, 52, and 72 ]
  46. Number of Participants with Anti-Drug Antibodies (ADAs) to Faricimab at Baseline and During the Study [ Time Frame: Predose at Day 1 (Baseline), Weeks 4, 24, 28, 52, and 72 ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04740905


Locations
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Sponsors and Collaborators
Hoffmann-La Roche
Chugai Pharmaceutical
Investigators
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Study Director: Clinical Trials Hoffmann-La Roche
More Information
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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT04740905    
Other Study ID Numbers: GR41984
2020-000440-63 ( EudraCT Number )
First Posted: February 5, 2021    Key Record Dates
Last Update Posted: July 13, 2023
Last Verified: July 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

Qualified researchers may request access to individual patient level data through the request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/).

For further details on Roche's Global Policy on Sharing of Clinical Study Information and how to request access to related clinical study documents, see here (https://www.roche.com/innovation/process/clinical-trials/data-sharing/).

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hoffmann-La Roche:
BRVO
Additional relevant MeSH terms:
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Macular Edema
Retinal Vein Occlusion
Edema
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Venous Thrombosis
Thrombosis
Embolism and Thrombosis
 Vascular Diseases
Cardiovascular Diseases
Aflibercept
Faricimab
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents