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A Study to Evaluate the Efficacy and Safety of Faricimab in Participants With Neovascular Age-Related Macular Degeneration (TENAYA)

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ClinicalTrials.gov Identifier: NCT03823287
Recruitment Status : Recruiting
First Posted : January 30, 2019
Last Update Posted : June 20, 2019
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Tracking Information
First Submitted Date  ICMJE January 29, 2019
First Posted Date  ICMJE January 30, 2019
Last Update Posted Date June 20, 2019
Actual Study Start Date  ICMJE February 19, 2019
Estimated Primary Completion Date August 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 29, 2019)
Average Change from Baseline in Best-Corrected Visual Acuity (BCVA) at Week 48 [ Time Frame: From Baseline up to 48 weeks ]
BCVA 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 NCT03823287 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 29, 2019)
  • Change from Baseline in BCVA Over Time [ Time Frame: From Baseline up to 112 weeks ]
  • Percentage of Participants Gaining ≥15 Letters in BCVA from Baseline Over Time [ Time Frame: From Baseline up to 112 weeks ]
  • Percentage of Participants Gaining ≥10 Letters in BCVA from Baseline Over Time [ Time Frame: From Baseline up to 112 weeks ]
  • Percentage of Participants Gaining ≥5 Letters in BCVA from Baseline Over Time [ Time Frame: From Baseline up to 112 weeks ]
  • Percentage of Participants Gaining ≥0 Letters in BCVA from Baseline Over Time [ Time Frame: From Baseline up to 112 weeks ]
  • Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA from Baseline Over Time [ Time Frame: From Baseline up to 112 weeks ]
  • Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA from Baseline Over Time [ Time Frame: From Baseline up to 112 weeks ]
  • Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA from Baseline Over Time [ Time Frame: From Baseline up to 112 weeks ]
  • Percentage of Participants Avoiding a Loss of >0 Letters in BCVA from Baseline Over Time [ Time Frame: From Baseline up to 112 weeks ]
  • Percentage of Participants with BCVA Snellen Equivalent of 20/40 or Better Over Time [ Time Frame: Up to 112 weeks ]
  • Percentage of Participants Gaining ≥15 Letters or Achieving BCVA of ≥84 Letters Over Time [ Time Frame: Up to 112 weeks ]
  • Percentage of Participants with BCVA Snellen Equivalent of 20/200 or Worse Over Time [ Time Frame: Up to 112 weeks ]
  • Percentage of Participants on Different Treatment Intervals at Weeks 48, 60, and 112 [ Time Frame: Weeks 48, 60, and 112 ]
  • Number of Study Drug Injections Received Through Weeks 48, 60, and 112 [ Time Frame: Weeks 48, 60, and 112 ]
  • Average Change from Baseline in Central Subfield Thickness (CST) at Week 48 [ Time Frame: From Baseline up to 48 weeks ]
  • Change from Baseline in CST Over Time [ Time Frame: From Baseline up to 112 weeks ]
  • Percentage of Participants with Absence of Intraretinal Fluid Over Time [ Time Frame: Up to 112 weeks ]
  • Percentage of Participants with Absence of Subretinal Fluid Over Time [ Time Frame: Up to 112 weeks ]
  • Percentage of Participants with Absence of Intraretinal Fluid and Subretinal Fluid Over Time [ Time Frame: Up to 112 weeks ]
  • Percentage of Participants with Absence of Intraretinal Cysts Over Time [ Time Frame: Up to 112 weeks ]
  • Percentage of Participants with Absence of Pigment Epithelial Detachment Over Time [ Time Frame: Up to 112 weeks ]
  • Change from Baseline in Total Area of Choroidal Neovascularization (CNV) Lesion at Weeks 48 and 112 [ Time Frame: Baseline, Weeks 48 and 112 ]
  • Change from Baseline in Total Area of CNV Leakage at Weeks 48 and 112 [ Time Frame: Baseline, Weeks 48 and 112 ]
  • Percentage of Participants with Ocular Adverse Events [ Time Frame: Up to 116 weeks ]
  • Percentage of Participants with Non-Ocular Adverse Events [ Time Frame: Up to 116 weeks ]
  • Plasma Concentration of Faricimab Over Time [ Time Frame: Pre-dose at Baseline, Weeks 4, 16, 20, 48, 76, and 112 ]
  • Percentage of Participants with Presence of Anti-Drug Antibodies [ Time Frame: Pre-dose at Baseline, Weeks 4, 20, 48, 76, and 112 ]
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 Neovascular Age-Related Macular Degeneration (TENAYA)
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 Neovascular Age-Related Macular Degeneration (TENAYA)
Brief Summary This study will evaluate the efficacy, safety, durability, and pharmacokinetics of faricimab administered at intervals as specified in the protocol, compared with aflibercept once every 8 weeks (Q8W), in participants with neovascular age-related macular degeneration (nAMD).
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 Wet Macular Degeneration
Intervention  ICMJE
  • Drug: Faricimab
    Faricimab will be administered by intravitreal injection into the study eye at intervals as specified in the study protocol.
    Other Names:
    • RO6867461
    • RG7716
  • Drug: Aflibercept
    Aflibercept will be administered by intravitreal injection into the study eye once every 4 weeks for 3 consecutive months, followed by once every 8 weeks (Q8W).
    Other Name: Eylea
  • Drug: Sham Procedure
    The sham is a procedure that mimics an intravitreal 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: Faricimab
    Interventions:
    • Drug: Faricimab
    • Drug: Sham Procedure
  • Active Comparator: Aflibercept
    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: January 29, 2019)
640
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 30, 2022
Estimated Primary Completion Date August 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Treatment-naïve choroidal neovascularization (CNV) secondary to age-related macular degeneration (nAMD) in the study eye
  • Ability to comply with the study protocol, in the investigator's judgment
  • For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use acceptable contraceptive measures that result in failure rate <1% per year during the treatment period and for at least 3 months after the final dose of study treatment
  • Other protocol-specified inclusion criteria may apply

Exclusion Criteria:

  • Uncontrolled blood pressure, defined as systolic blood pressure >180 millimeters of mercury (mmHg) and/or diastolic blood pressure >100 mmHg while a patient is at rest on Day 1
  • Pregnancy or breastfeeding, or intention to become pregnant during the study
  • CNV due to causes other than AMD in the study eye
  • Any history of macular pathology unrelated to AMD affecting vision or contributing to the presence of intraretinal or subretinal fluid in the study eye
  • Any concurrent intraocular condition in the study eye that, in the opinion of the investigator, could either reduce the potential for visual improvement or require medical or surgical intervention during the study
  • Uncontrolled glaucoma in the study eye
  • Any prior or concomitant treatment for CNV or vitreomacular-interface abnormalities in the study eye
  • Prior IVT administration of faricimab in either eye
  • History of idiopathic or autoimmune-associated uveitis in either eye
  • Active ocular inflammation or suspected or active ocular or periocular infection in either eye
  • Other protocol-specified exclusion criteria may apply
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Reference Study ID Number: GR40306 www.roche.com/about_roche/roche_worldwide.htm 888-662-6782 (U.S. Only) global-roche-genentech-trials@gene.com
Listed Location Countries  ICMJE Canada,   Germany,   Hungary,   Israel,   Italy,   Japan,   Mexico,   Netherlands,   Poland,   Russian Federation,   Spain,   Switzerland,   Turkey,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03823287
Other Study ID Numbers  ICMJE GR40306
2018-002152-32 ( 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 clinical study data request platform (www.clinicalstudydatarequest.com). Further details on Roche's criteria for eligible studies are available here (https://clinicalstudydatarequest.com/Study-Sponsors/Study-Sponsors-Roche.aspx).

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 Not Provided
Investigators  ICMJE
Study Director: Clinical Trials Hoffmann-La Roche
PRS Account Hoffmann-La Roche
Verification Date June 2019

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