Clinical Trial: AVENUE: A Proof-of-Concept Study of RG7716 in Participants With Choroidal Neovascularization (CNV) Secondary to Age-Related Macular Degeneration (AMD)

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: 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 Effi

Brief Summary: This study will evaluate the safety, tolerability, pharmacokinetics, and efficacy of RG7716 in participants with subfoveal CNV secondary to AMD.

Detailed Summary:
Sponsor: Hoffmann-La Roche

Current Primary Outcome: Change from Baseline in BCVA letter score [ Time Frame: Up to approximately 36 weeks ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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 ]


Original Secondary Outcome: Same as current

Information By: Hoffmann-La Roche

Dates:
Date Received: June 12, 2015
Date Started: August 2015
Date Completion: July 2017
Last Updated: September 6, 2016
Last Verified: September 2016