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A Proof-of-Concept Study of Faricimab (RO6867461) in Participants With Choroidal Neovascularization (CNV) Secondary to Age-Related Macular Degeneration (AMD) (AVENUE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02484690
Recruitment Status : Completed
First Posted : June 30, 2015
Last Update Posted : October 4, 2019
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Tracking Information
First Submitted Date  ICMJE June 12, 2015
First Posted Date  ICMJE June 30, 2015
Last Update Posted Date October 4, 2019
Actual Study Start Date  ICMJE August 11, 2015
Actual Primary Completion Date September 26, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 7, 2017)
Mean Change From Baseline in BCVA Letter Score [ Time Frame: Baseline, Week 36 ]
Original Primary Outcome Measures  ICMJE
 (submitted: June 24, 2015)
Change from Baseline in BCVA letter score [ Time Frame: Up to approximately 36 weeks ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 20, 2019)
  • Percentage of Participants Gaining Greater than or Equal to (>/=) 15 Letters From Baseline in BCVA Letter Score at Week 36 [ Time Frame: Baseline, Week 36 ]
  • Percentage of Participants With BCVA Score >/=20/40 Letters [ Time Frame: Week 36 ]
  • Percentage of Participants With BCVA Score </=20/200 Letters [ Time Frame: Week 36 ]
  • Mean Change From Baseline in Foveal Center Point Thickness, as Measured by Spectral Domain Optical Coherence Tomography (SD-OCT) [ Time Frame: Baseline, Week 36 ]
  • Mean Change From Baseline in Central Subfield Thickness, as Measured by SD-OCT [ Time Frame: Baseline, Week 36 ]
  • Percentage of Participants With no Intraretinal Fluid, Subretinal Fluid, Cysts, or Pigment Epithelial Detachment, as Measured by SD-OCT [ Time Frame: Week 36 ]
  • Mean Change From Baseline in Total Area of CNV, as Measured by Fundus Fluorescein Angiography (FFA) [ Time Frame: Baseline, Week 36 ]
  • Mean Change From Baseline in Total Area of CNV Component, as Measured by FFA [ Time Frame: Baseline, Week 36 ]
  • Change From Baseline in Total Area of Leakage, as Measured by FFA [ Time Frame: Baseline, Week 36 ]
  • Percentage of Participants With Adverse Events [ Time Frame: Baseline up to 36 weeks ]
  • Clearance of Faricimab [ Time Frame: Up to 36 weeks ]
  • Volume of Distribution of Faricimab [ Time Frame: Up to 36 weeks ]
  • Percentage of Participants With Anti-Therapeutic Antibodies to Faricimab [ Time Frame: Baseline, Predose (0 hour) on Days 1, 28, 84, 112, 168, 252 or early termination (up to 252 days overall) ]
Original Secondary Outcome Measures  ICMJE
 (submitted: June 24, 2015)
  • Percentage of participants gaining at least 15 letters from Baseline in BCVA letter score [ Time Frame: Up to approximately 36 weeks ]
  • Percentage of participants with BCVA letter score 20/40 or better [ Time Frame: Up to approximately 36 weeks ]
  • Percentage of participants with BCVA letter score 20/200 or worse [ Time Frame: Up to approximately 36 weeks ]
  • Change from Baseline in foveal center point thickness [ Time Frame: Up to approximately 36 weeks ]
  • Change from Baseline in central subfield thickness [ Time Frame: Up to approximately 36 weeks ]
  • Percentage of participants with no intraretinal fluid, subretinal fluid, cysts, or pigment epithelial detachment [ Time Frame: Up to approximately 36 weeks ]
  • Change from Baseline in total area of CNV [ Time Frame: Up to approximately 36 weeks ]
  • Change from Baseline in total area of CNV component [ Time Frame: Up to approximately 36 weeks ]
  • Change from Baseline in total area of leakage [ Time Frame: Up to approximately 36 weeks ]
  • Incidence of adverse events [ Time Frame: Up to approximately 40 weeks ]
  • Clearance of RG7716 [ Time Frame: Up to approximately 36 weeks ]
  • Volume of distribution of RG7716 [ Time Frame: Up to approximately 36 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Proof-of-Concept Study of Faricimab (RO6867461) in Participants With Choroidal Neovascularization (CNV) Secondary to Age-Related Macular Degeneration (AMD)
Official Title  ICMJE A Multiple-Center, Multiple-Dose and Regimen, Randomized, Active Comparator Controlled, Double-Masked, Parallel Group, 36 Week Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Efficacy of RO6867461 Administered Intravitreally in Patients With Choroidal Neovascularization Secondary to Age-Related Macular Degeneration
Brief Summary This multiple-center, multiple-dose and regimen, randomized, double-masked active comparator-controlled, double-masked, five parallel group, 36-week study will evaluate the efficacy, safety, tolerability, and pharmacokinetics of faricimab (RO6867461) in participants with CNV secondary to AMD.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Choroidal Neovascularization
Intervention  ICMJE
  • Drug: Faricimab
    Faricimab will be administered as per the regimen specified in individual arm.
    Other Names:
    • RO6867461
    • RG7716
  • Drug: Ranibizumab
    Ranibizumab will be administered as per the regimen specified in individual arm.
Study Arms  ICMJE
  • Active Comparator: Ranibizumab, 0.5 mg Every 4 Weeks (Q4W)
    Participants will receive ranibizumab, 0.5 milligrams (mg) intravitreal (IVT) Q4W up to Week 32 (total 9 injections).
    Intervention: Drug: Ranibizumab
  • Experimental: Faricimab, 1.5 mg Q4W
    Participants will receive faricimab 1.5 mg IVT Q4W up to Week 32 (total 9 injections).
    Intervention: Drug: Faricimab
  • Experimental: Faricimab, 6 mg Q4W
    Participants will receive faricimab 6 mg IVT Q4W up to Week 32 (9 injections).
    Intervention: Drug: Faricimab
  • Experimental: Faricimab, 6 mg Every 4-8 weeks
    Participants will receive faricimab, 6 mg IVT (4 injections) Q4W up to Week 12, followed by 6 mg IVT (2 injections) every 8 weeks up to Week 28.
    Intervention: Drug: Faricimab
  • Experimental: Ranibizumab 0.5 mg + Faricimab 6 mg Q4W
    Participants will receive ranibizumab, 0.5 mg IVT (3 injections) Q4W up to Week 8, followed by faricimab, 6 mg IVT (6 injections) Q4W up to Week 32.
    Interventions:
    • Drug: Faricimab
    • Drug: Ranibizumab
Publications * Sahni J, Dugel PU, Patel SS, Chittum ME, Berger B, Del Valle Rubido M, Sadikhov S, Szczesny P, Schwab D, Nogoceke E, Weikert R, Fauser S. Safety and Efficacy of Different Doses and Regimens of Faricimab vs Ranibizumab in Neovascular Age-Related Macular Degeneration: The AVENUE Phase 2 Randomized Clinical Trial. JAMA Ophthalmol. 2020 Jul 30. doi: 10.1001/jamaophthalmol.2020.2685. [Epub ahead of print]

*   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 Completed
Actual Enrollment  ICMJE
 (submitted: July 7, 2017)
273
Original Estimated Enrollment  ICMJE
 (submitted: June 24, 2015)
271
Actual Study Completion Date  ICMJE September 26, 2017
Actual Primary Completion Date September 26, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Treatment-naive with CNV secondary to AMD, with subfoveal CNV or juxtafoveal CNV with a subfoveal component related to the CNV activity by FFA or SD-OCT
  • Active CNV

Exclusion Criteria:

  • CNV due to causes other than AMD
  • Subretinal hemorrhage, fibrosis, or atrophy involving either the fovea or more than 50% of the total lesion area
  • Cataract surgery within 3 months of baseline, or any other previous intraocular surgery
  • Major illness or surgery within 1 month prior to Screening
  • Glycosylated hemoglobin (HbA1c) above 7.5%
  • Uncontrolled blood pressure
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 information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02484690
Other Study ID Numbers  ICMJE BP29647
Has Data Monitoring Committee Not Provided
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 September 2019

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