Clinical Trial: A Study of Safety, Tolerability, and Evidence of Activity of FCFD4514S Administered Monthly or Every Other Month to Patients With Geographic Atrophy
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Phase Ib/II, Multicenter, Randomized, Single-Masked, Sham Injection-Controlled Study of Safety, Tolerability, and Evidence of Activity of FCFD4514S Intravitreal Injections Administered Monthly or Ev
Brief Summary: This is a Phase Ib/II, multicenter, randomized, single-masked, sham-injection-controlled study of safety, tolerability, and evidence of activity of FCFD4514S intravitreal injections administered monthly or every other month in patients with geographic atrophy.
Detailed Summary:
Sponsor: Genentech, Inc.
Current Primary Outcome: Growth rate of geographic atrophy (GA) lesion area from baseline [ Time Frame: Month 18 ]
Original Primary Outcome: Growth rate of geographic atrophy (GA) lesion area from baseline [ Time Frame: Month 12 ]
Current Secondary Outcome: Mean change in best corrected visual acuity (BCVA) from baseline [ Time Frame: Month 18 ]
Original Secondary Outcome: Same as current
Information By: Genentech, Inc.
Dates:
Date Received: October 25, 2010
Date Started: February 2011
Date Completion:
Last Updated: November 1, 2016
Last Verified: November 2016