A Phase II, Multicenter, Randomized, Single-Masked, Sham-Controlled Study to Assess Safety, Tolerability, and Efficacy of Intravitreal Injections of FHTR2163 in Patients With Geographic Atrophy Secondary to Age-Related Macular Degeneration (GALLEGO)

Active Clinical Trials // Jun 12 2019

Sponsor: Genentech, Inc.
Principal Investigator: Barb Blodi, MD
Study Coordinator: Kris Dietzman

Study Objective:

This study will evaluate the safety, tolerability, and efficacy of intravitreal injections of RO7171009 administered every 4 weeks (Q4W) or every 8 weeks (Q8W) for approximately 76 weeks in participants with geographic atrophy (GA) secondary to age-related macular degeneration (AMD) compared with sham control.

Study Arms:

 

  • Experimental: RO7171009 Q4W
    Participants will receive RO7171009 every 4 weeks (Q4W).
    Intervention: Drug: RO7171009

 

  • Sham Comparator: Sham Control Q4W
    Participants will receive Sham-control Q4W.
    Intervention: Drug: Sham Control

 

  • Experimental: RO7171009 Q8W
    Participants will receive RO7171009 every 8 weeks (Q8W).
    Intervention: Drug: RO7171009

 

  • Sham Comparator: Sham Control Q8W
    Participants will receive Sham-control Q8W.
    Intervention: Drug: Sham Control

 

Diagnosis and Key Eligibility Criteria:

  • Geographic Atrophy Secondary to Age-Related Macular Degeneration
  • Age >/= 60 years at time of signing Informed Consent Form;
  • Visual acuity: best-corrected visual acuity (BCVA) letter score >/= 24 letters (Snellen equivalent of 20/320 or better);
  • Well-demarcated area of GA secondary to AMD with no evidence of prior or active choroidal neovascularization (CNV) in either eye.

Duration of Study: 18 months 

For more information, contact Kris Dietzman 608-263-9035.