A Study Investigating the Safety and Efficacy of Lampalizumab Intravitreal Injections in Patients with Geographic Atrophy Secondary to Age-Related Macular Degeneration (SPECTRI)

Status: Recruiting

Sponsor:  Hoffmann-La Roche

Product name: LAMPALIZUMAB

Brief summary:

This study is a Phase III, double-masked, multicenter, randomized, sham injection-controlled study evaluating the efficacy and safety of lampalizumab administered by intravitreal injections in patients with geographic atrophy (GA) secondary to age-related macular degeneration (AMD). Target sample size is 936.

Primary outcome:

  1. Change in GA area, as assessed by retinal imaging Time frame: From baseline to Week 48

Key secondary outcomes:

  1. Change in best corrected visual acuity (BCVA) Time frame: From baseline to 2 years
  2. Change in additional measures of visual function Time frame: From baseline to 2 years

Inclusion criteria:

  • Participants aged >/= 50 years
  • Well demarcated area(s) of GA secondary to AMD with no evidence of prior or active choroidal neovascularization (CNV) in both eyes

Exclusion criteria:

  • Ocular Exclusion Criteria: Study Eye
  • History of vitrectomy surgery, submacular surgery, or other surgical intervention for AMD
  • Previous laser photocoagulation for CNV, diabetic macular edema, retinal vein occlusion, and proliferative diabetic retinopathy
  • Previous intravitreal drug delivery (e.g., intravitreal corticosteroid injection, anti-angiogenic drugs, anti-complement agents, or device implantation)
  • Ocular Exclusion Criteria: Both Eyes
  • GA in either eye due to causes other than AMD
  • Previous treatment with eculizumab, lampalizumab and/or fenretinide