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A Study to Evaluate the Efficacy and Safety of Faricimab in Participants With Macular Edema Secondary to Central Retinal or Hemiretinal Vein Occlusion (COMINO)

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ClinicalTrials.gov Identifier: NCT04740931
Recruitment Status : Recruiting
First Posted : February 5, 2021
Last Update Posted : September 13, 2021
Sponsor:
Collaborator:
Chugai Pharmaceutical
Information provided by (Responsible Party):
Hoffmann-La Roche

Tracking Information
First Submitted Date  ICMJE February 3, 2021
First Posted Date  ICMJE February 5, 2021
Last Update Posted Date September 13, 2021
Actual Study Start Date  ICMJE March 2, 2021
Estimated Primary Completion Date February 16, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 3, 2021)
Change from Baseline in Best-Corrected Visual Acuity (BCVA) at Week 24 [ Time Frame: Baseline and Week 24 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 3, 2021)
  • Part 1: Change from Baseline in BCVA at Specified Timepoints Through Week 24 [ Time Frame: Baseline, Weeks 4, 8, 12, 16, 20, and 24 ]
  • Part 1: Percentage of Participants Gaining ≥15 Letters in BCVA from Baseline at Week 24 [ Time Frame: Baseline and Week 24 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • Part 1: Percentage of Participants Avoiding a Loss of >0 Letters in BCVA from Baseline at Specified Timepoints Through Week 24 [ Time Frame: Baseline, Weeks 4, 8, 12, 16, 20, and 24 ]
  • 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 ]
  • Part 1: Percentage of Participants with BCVA Snellen Equivalent of 20/40 or Better at Specified Timepoints Through Week 24 [ Time Frame: Baseline, Weeks 4, 8, 12, 16, 20, and 24 ]
  • Part 1: Percentage of Participants with BCVA Snellen Equivalent of 20/200 or Worse at Specified Timepoints Through Week 24 [ Time Frame: Baseline, Weeks 4, 8, 12, 16, 20, and 24 ]
  • 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 ]
  • Part 1: Change from Baseline in National Eye Institute 25-Item Visual Functioning Questionnaire (NEI VFQ-25) Composite Score at Specified Timepoints Through Week 24 [ Time Frame: Baseline, Weeks 4, 8, 12, 16, 20, and 24 ]
  • Part 2: Change from Baseline in BCVA at Specified Timepoints from Week 24 Through Week 72 [ Time Frame: Baseline and every 4 weeks from Week 24 to Week 72 ]
  • Part 2: Percentage of Participants Gaining ≥15 Letters in BCVA from Baseline at Week 72 [ Time Frame: Baseline and Week 72 ]
  • Part 2: Percentage of Participants Gaining ≥15 Letters in BCVA from Baseline at Specified Timepoints from Week 24 Through Week 72 [ Time Frame: Baseline and every 4 weeks from Week 24 to Week 72 ]
  • Part 2: Percentage of Participants Gaining ≥10 Letters in BCVA from Baseline at Specified Timepoints from Week 24 Through Week 72 [ Time Frame: Baseline and every 4 weeks from Week 24 to Week 72 ]
  • Part 2: Percentage of Participants Gaining ≥5 Letters in BCVA from Baseline at Specified Timepoints from Week 24 Through Week 72 [ Time Frame: Baseline and every 4 weeks from Week 24 to Week 72 ]
  • Part 2: Percentage of Participants Gaining >0 Letters in BCVA from Baseline at Specified Timepoints from Week 24 Through Week 72 [ Time Frame: Baseline and every 4 weeks from Week 24 to Week 72 ]
  • Part 2: Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA from Baseline at Specified Timepoints from Week 24 Through Week 72 [ Time Frame: Baseline and every 4 weeks from Week 24 to Week 72 ]
  • Part 2: Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA from Baseline at Specified Timepoints from Week 24 Through Week 72 [ Time Frame: Baseline and every 4 weeks from Week 24 to Week 72 ]
  • Part 2: Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA from Baseline at Specified Timepoints from Week 24 Through Week 72 [ Time Frame: Baseline and every 4 weeks from Week 24 to Week 72 ]
  • Part 2: Percentage of Participants Avoiding a Loss of >0 Letters in BCVA from Baseline at Specified Timepoints from Week 24 Through Week 72 [ Time Frame: Baseline and every 4 weeks from Week 24 to Week 72 ]
  • Part 2: Percentage of Participants Achieving ≥84 Letters (20/20 Snellen Equivalent) in BCVA at Specified Timepoints from Week 24 Through Week 72 [ Time Frame: Every 4 weeks from Week 24 to Week 72 ]
  • Part 2: Percentage of Participants with BCVA Snellen Equivalent of 20/40 or Better at Specified Timepoints from Week 24 Through Week 72 [ Time Frame: Every 4 weeks from Week 24 to Week 72 ]
  • Part 2: Percentage of Participants with BCVA Snellen Equivalent of 20/200 or Worse at Specified Timepoints from Week 24 Through Week 72 [ Time Frame: Every 4 weeks from Week 24 to Week 72 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • Part 2: Percentage of Participants on Different Treatment Intervals at Week 72 [ Time Frame: Week 72 ]
  • Part 2: Number of Study Drug Injections Received from Week 24 Through Week 72 [ Time Frame: From Week 24 to Week 72 ]
  • Part 2: Change from Baseline in Central Subfield Thickness at Specified Timepoints from Week 24 Through Week 72 [ Time Frame: Baseline and every 4 weeks from Week 24 to Week 72 ]
  • Part 2: Change from Baseline in NEI VFQ-25 Questionnaire Composite Score at Specified Timepoints from Week 24 Through Week 72 [ Time Frame: Baseline and every 4 weeks from Week 24 to Week 72 ]
  • 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) ]
  • 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) ]
  • Plasma Concentration of Faricimab Over Time [ Time Frame: Predose at Day 1, Weeks 4, 24, 28, 52, and 72 ]
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Evaluate the Efficacy and Safety of Faricimab in Participants With Macular Edema Secondary to Central Retinal or Hemiretinal Vein Occlusion
Official Title  ICMJE 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 Central Retinal or Hemiretinal Vein Occlusion
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 patients with macular edema due to central retinal vein occlusion (CRVO) or hemiretinal vein occlusion (HRVO).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Macular Edema
  • Central Retinal Vein Occlusion
  • Hemiretinal Vein Occlusion
Intervention  ICMJE
  • Drug: Faricimab
    Faricimab will be administered by intravitreal (IVT) injection as specified in each treatment arm.
    Other Names:
    • RG7716
    • RO6867461
  • 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 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.
Study Arms  ICMJE
  • 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).
    Interventions:
    • Drug: Faricimab
    • Procedure: Sham Procedure
  • 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).
    Interventions:
    • Drug: Faricimab
    • Drug: Aflibercept
    • Procedure: Sham Procedure
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 3, 2021)
750
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 18, 2024
Estimated Primary Completion Date February 16, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Foveal center-involved macular edema due to central retinal vein occlusion (CRVO) or hemiretinal vein occlusion (HRVO), 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)
  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Reference Study ID Number: GR41986 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. only) global-roche-genentech-trials@gene.com
Listed Location Countries  ICMJE Argentina,   Australia,   Austria,   Brazil,   China,   Czechia,   France,   Germany,   Hong Kong,   Hungary,   Israel,   Italy,   Japan,   Korea, Republic of,   Poland,   Portugal,   Russian Federation,   Singapore,   Spain,   Taiwan,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04740931
Other Study ID Numbers  ICMJE GR41986
2020-000441-13 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
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/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).

Responsible Party Hoffmann-La Roche
Study Sponsor  ICMJE Hoffmann-La Roche
Collaborators  ICMJE Chugai Pharmaceutical
Investigators  ICMJE
Study Director: Clinical Trials Hoffmann-La Roche
PRS Account Hoffmann-La Roche
Verification Date September 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP