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

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ClinicalTrials.gov Identifier: NCT02484690
Recruitment Status : Completed
First Posted : June 30, 2015
Last Update Posted : April 17, 2018
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

June 12, 2015
June 30, 2015
April 17, 2018
August 11, 2015
September 26, 2017   (Final data collection date for primary outcome measure)
Mean Change From Baseline in BCVA Letter Score [ Time Frame: Baseline, Week 36 ]
Change from Baseline in BCVA letter score [ Time Frame: Up to approximately 36 weeks ]
Complete list of historical versions of study NCT02484690 on ClinicalTrials.gov Archive Site
  • 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 RO6867461 [ Time Frame: Up to 36 weeks ]
  • Volume of Distribution of RO6867461 [ Time Frame: Up to 36 weeks ]
  • Percentage of Participants With Anti-Therapeutic Antibodies to RO6867461 [ Time Frame: Baseline, Predose (0 hour) on Days 1, 28, 84, 112, 168, 252 or early termination (up to 252 days overall) ]
  • 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 ]
Not Provided
Not Provided
 
A Proof-of-Concept Study of RO6867461 in Participants With Choroidal Neovascularization (CNV) Secondary to Age-Related Macular Degeneration (AMD)
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
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 RO6867461 in participants with CNV secondary to AMD.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Choroidal Neovascularization
  • Drug: RO6867461
    RO6867461 will be administered as per the regimen specified in individual arm.
  • Drug: Ranibizumab
    Ranibizumab will be administered as per the regimen specified in individual arm.
  • 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: RO6867461, 1.5 mg Q4W
    Participants will receive RO6867461 1.5 mg IVT Q4W up to Week 32 (total 9 injections).
    Intervention: Drug: RO6867461
  • Experimental: RO6867461, 6 mg Q4W
    Participants will receive RO6867461 6 mg IVT Q4W up to Week 32 (9 injections).
    Intervention: Drug: RO6867461
  • Experimental: RO6867461, 6 mg Every 4-8 weeks
    Participants will receive RO6867461, 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: RO6867461
  • Experimental: Ranibizumab 0.5 mg + RO6867461 6 mg Q4W
    Participants will receive ranibizumab, 0.5 mg IVT (3 injections) Q4W up to Week 8, followed by RO6867461, 6 mg IVT (6 injections) Q4W up to Week 32.
    Interventions:
    • Drug: RO6867461
    • Drug: Ranibizumab
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
273
271
September 26, 2017
September 26, 2017   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
50 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT02484690
BP29647
Not Provided
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
April 2018

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