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A Study to Evaluate the Efficacy and Safety of Faricimab (RO6867461) in Participants With Diabetic Macular Edema (YOSEMITE)

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ClinicalTrials.gov Identifier: NCT03622580
Recruitment Status : Recruiting
First Posted : August 9, 2018
Last Update Posted : August 12, 2019
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Tracking Information
First Submitted Date  ICMJE August 1, 2018
First Posted Date  ICMJE August 9, 2018
Last Update Posted Date August 12, 2019
Actual Study Start Date  ICMJE September 5, 2018
Estimated Primary Completion Date September 30, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 7, 2018)
Average Change From Baseline in Best-Corrected Visual Acuity (BCVA) at 1 Year [ Time Frame: Baseline (Day 1) and 1 year ]
As measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03622580 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 24, 2019)
  • Percentage of Participants with a ≥2-Step Diabetic Retinopathy Severity (DRS) Improvement From Baseline on the ETDRS Diabetic Retinopathy Severity Scale (DRSS) at 1 Year [ Time Frame: Baseline and 1 year ]
  • Change From Baseline in BCVA Over Time [ Time Frame: From Baseline up to 2 years ]
  • Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline Over Time [ Time Frame: From Baseline up to 2 years ]
  • Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline Over Time [ Time Frame: From Baseline up to 2 years ]
  • Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline Over Time [ Time Frame: From Baseline up to 2 years ]
  • Percentage of Participants Gaining ≥0 Letters in BCVA From Baseline Over Time [ Time Frame: From Baseline up to 2 years ]
  • Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Baseline Over Time [ Time Frame: From Baseline up to 2 years ]
  • Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Baseline Over Time [ Time Frame: From Baseline up to 2 years ]
  • Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Baseline Over Time [ Time Frame: From Baseline up to 2 years ]
  • Percentage of Participants Avoiding a Loss of >0 Letters in BCVA From Baseline Over Time [ Time Frame: From Baseline up to 2 years ]
  • Percentage of Participants Gaining ≥15 Letters or Achieving BCVA of ≥84 Letters Over Time [ Time Frame: Up to 2 years ]
  • Percentage of Participants with BCVA Snellen Equivalent of 20/40 or Better Over Time [ Time Frame: Up to 2 years ]
  • Percentage of Participants with BCVA Snellen Equivalent of 20/200 or Worse Over Time [ Time Frame: Up to 2 years ]
  • Percentage of Participants with a ≥2-Step DRS Improvement From Baseline on the ETDRS DRSS Over Time [ Time Frame: From Baseline up to 2 years ]
  • Percentage of Participants with a ≥3-Step DRS Improvement From Baseline on the ETDRS DRSS Over Time [ Time Frame: From Baseline up to 2 years ]
  • Percentage of Participants Who Develop New Proliferative Diabetic Retinopathy Over Time [ Time Frame: Up to 2 years ]
  • Percentage of Participants in the Faricimab As Specified in Protocol Arm on a Q4W, Q8W, Q12W, or Q16W Treatment Interval at 1 Year [ Time Frame: 1 year ]
  • Percentage of Participants in the Faricimab As Specified in Protocol Arm on a Q4W, Q8W, Q12W, or Q16W Treatment Interval at 2 Years [ Time Frame: 2 years ]
  • Change From Baseline in Central Subfield Thickness Over Time [ Time Frame: From Baseline up to 2 years ]
  • Change From Baseline in Central Subfield Thickness at 1 Year [ Time Frame: Baseline and 1 year ]
  • Percentage of Participants with Absence of DME Over Time [ Time Frame: Up to 2 years ]
  • Percentage of Participants with Absence of Intraretinal Fluid Over Time [ Time Frame: Up to 2 years ]
  • Percentage of Participants with Absence of Subretinal Fluid Over Time [ Time Frame: Up to 2 years ]
  • Percentage of Participants with Absence of Intraretinal Fluid and Subretinal Fluid Over Time [ Time Frame: Up to 2 years ]
  • Change From Baseline in National Eye Institute Visual Functioning Questionnaire-25 (NEI VFQ-25) Composite Score Over Time [ Time Frame: From Baseline up to 2 years ]
  • Percentage of Participants with At Least One Ocular Adverse Event [ Time Frame: Up to 2 years ]
  • Percentage of Participants with At Least One Non-Ocular Adverse Event [ Time Frame: Up to 2 years ]
  • Plasma Concentration of Faricimab Over Time [ Time Frame: Pre-dose on Day 1; Weeks 4, 28, 52, 76, and 100; and at Early Termination Visit (up to 2 years) ]
  • Percentage of Participants with Presence of Anti-Drug Antibodies [ Time Frame: Pre-dose on Day 1; Weeks 4, 28, 52, 76, and 100; and at Early Termination Visit (up to 2 years) ]
Original Secondary Outcome Measures  ICMJE
 (submitted: August 7, 2018)
  • Percentage of Participants with a ≥2-Step Diabetic Retinopathy Severity (DRS) Improvement From Baseline on the ETDRS Diabetic Retinopathy Severity Scale (DRSS) at 1 Year [ Time Frame: Baseline and 1 year ]
  • Change From Baseline in BCVA Over Time [ Time Frame: From Baseline up to 2 years ]
  • Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline Over Time [ Time Frame: From Baseline up to 2 years ]
  • Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline Over Time [ Time Frame: From Baseline up to 2 years ]
  • Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline Over Time [ Time Frame: From Baseline up to 2 years ]
  • Percentage of Participants Gaining ≥0 Letters in BCVA From Baseline Over Time [ Time Frame: From Baseline up to 2 years ]
  • Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Baseline Over Time [ Time Frame: From Baseline up to 2 years ]
  • Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Baseline Over Time [ Time Frame: From Baseline up to 2 years ]
  • Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Baseline Over Time [ Time Frame: From Baseline up to 2 years ]
  • Percentage of Participants Avoiding a Loss of ≥0 Letters in BCVA From Baseline Over Time [ Time Frame: From Baseline up to 2 years ]
  • Percentage of Participants with a ≥2-Step DRS Improvement From Baseline on the ETDRS DRSS Over Time [ Time Frame: From Baseline up to 2 years ]
  • Percentage of Participants with a ≥3-Step DRS Improvement From Baseline on the ETDRS DRSS Over Time [ Time Frame: From Baseline up to 2 years ]
  • Percentage of Participants Gaining ≥15 Letters or Achieving BCVA of ≥84 Letters Over Time [ Time Frame: Up to 2 years ]
  • Percentage of Participants with BCVA Snellen Equivalent of 20/40 or Better Over Time [ Time Frame: Up to 2 years ]
  • Percentage of Participants with BCVA Snellen Equivalent of 20/200 or Worse Over Time [ Time Frame: Up to 2 years ]
  • Percentage of Participants Who Develop New Proliferative Diabetic Retinopathy Over Time [ Time Frame: Up to 2 years ]
  • Percentage of Participants in the RO6867461 As Specified in Protocol Arm on a Q4W, Q8W, Q12W, or Q16W Treatment Interval at 1 Year [ Time Frame: 1 year ]
  • Percentage of Participants in the RO6867461 As Specified in Protocol Arm on a Q4W, Q8W, Q12W, or Q16W Treatment Interval at 2 Years [ Time Frame: 2 years ]
  • Change From Baseline in Central Subfield Thickness (CST) Over Time [ Time Frame: From Baseline up to 2 years ]
  • Percentage of Participants with Absence of DME Over Time [ Time Frame: Up to 2 years ]
  • Percentage of Participants with Absence of Intraretinal Fluid Over Time [ Time Frame: Up to 2 years ]
  • Percentage of Participants with Absence of Subretinal Fluid Over Time [ Time Frame: Up to 2 years ]
  • Percentage of Participants with Absence of Intraretinal Fluid and Subretinal Fluid Over Time [ Time Frame: Up to 2 years ]
  • Change From Baseline in National Eye Institute Visual Functioning Questionnaire-25 (NEI VFQ-25) Composite Score Over Time [ Time Frame: From Baseline up to 2 years ]
  • Percentage of Participants With Ocular Adverse Events [ Time Frame: Up to 2 years ]
  • Percentage of Participants With Non-Ocular Adverse Events [ Time Frame: Up to 2 years ]
  • Plasma Concentration of RO6867461 Over Time [ Time Frame: Pre-dose on Day 1; Weeks 4, 28, 52, 76, and 100; and at Early Termination Visit (up to 2 years) ]
  • Percentage of Participants with Presence of Anti-Drug Antibodies [ Time Frame: Pre-dose on Day 1; Weeks 4, 28, 52, 76, and 100; and at Early Termination Visit (up to 2 years) ]
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 (RO6867461) in Participants With Diabetic Macular Edema (YOSEMITE)
Official Title  ICMJE A Phase III, Multicenter, Randomized, Double-Masked, Active Comparator-Controlled Study to Evaluate the Efficacy and Safety of Faricimab (RO6867461) in Patients With Diabetic Macular Edema (YOSEMITE)
Brief Summary This study will evaluate the efficacy, safety, and pharmacokinetics of faricimab administered at 8-week intervals or as specified in the protocol following treatment initiation, compared with aflibercept once every 8 weeks (Q8W), in participants with diabetic macular edema (DME).
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 Diabetic Macular Edema
Intervention  ICMJE
  • Drug: Aflibercept
    Aflibercept will be administered by intravitreal (IVT) injection into the study eye once every 8 weeks (Q8W).
    Other Name: Eylea
  • Drug: Faricimab
    Faricimab will be administered by IVT injection into the study eye either once every 8 weeks (Q8W) in arm A or as specified in the protocol in arm B.
    Other Names:
    • RO6867461
    • RG7716
  • Drug: Sham Procedure
    The sham is a procedure that mimics an IVT injection and involves the blunt end of an empty syringe (without a needle) being pressed against the anesthetized eye. It will be administered to participants in all three treatments arms at applicable clinic visits to maintain masking among treatment arms.
Study Arms  ICMJE
  • Experimental: A: Faricimab Q8W
    Interventions:
    • Drug: Faricimab
    • Drug: Sham Procedure
  • Experimental: B: Faricimab As Specified in Protocol
    Interventions:
    • Drug: Faricimab
    • Drug: Sham Procedure
  • Active Comparator: C: Aflibercept Q8W
    Interventions:
    • Drug: Aflibercept
    • Drug: 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: August 7, 2018)
900
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2, 2022
Estimated Primary Completion Date September 30, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Documented diagnosis of diabetes mellitus (Type 1 or Type 2)
  • Hemoglobin A1c (HbA1c) of less than or equal to (≤) 10% within 2 months prior to Day 1
  • Macular thickening secondary to diabetic macular edema (DME) involving the center of the fovea
  • Decreased visual acuity attributable primarily to DME
  • Ability and willingness to undertake all scheduled visits and assessments
  • For women of childbearing potential: agreement to remain abstinent or use acceptable contraceptive methods that result in a failure rate of <1% per year during the treatment period and for at least 3 months after the final dose of study treatment

Exclusion Criteria:

  • Currently untreated diabetes mellitus or previously untreated patients who initiated oral or injectable anti-diabetic medication within 3 months prior to Day 1
  • Uncontrolled blood pressure, defined as a systolic value greater than (>)180 millimeters of mercury (mmHg) and/or a diastolic value >100 mmHg while a patient is at rest
  • Currently pregnant or breastfeeding, or intend to become pregnant during the study
  • Treatment with panretinal photocoagulation or macular laser within 3 months prior to Day 1 to the study eye
  • Any intraocular or periocular corticosteroid treatment within the past 6 months prior to Day 1 to the study eye
  • Prior administration of IVT faricimab in either eye
  • Active intraocular or periocular infection or active intraocular inflammation in the study eye
  • Any current or history of ocular disease other than DME that may confound assessment of the macula or affect central vision in the study eye
  • 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 DME in the study eye
  • Other protocol-specified inclusion/exclusion criteria may apply
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: GR40349 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. Only) global-roche-genentech-trials@gene.com
Listed Location Countries  ICMJE Austria,   Bulgaria,   France,   Germany,   Hungary,   Israel,   Italy,   Japan,   Mexico,   Peru,   Poland,   Russian Federation,   Slovakia,   Spain,   Turkey,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03622580
Other Study ID Numbers  ICMJE GR40349
2017-005104-10 ( 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 Not Provided
Responsible Party Hoffmann-La Roche
Study Sponsor  ICMJE Hoffmann-La Roche
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Clinical Trials Hoffmann-La Roche
PRS Account Hoffmann-La Roche
Verification Date August 2019

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