NCT02288559

A Study of Lampalizumab Intravitreal Injections Administered Every Two Weeks or Every Four Weeks to Participants With Geographic Atrophy

A Phase II, Multicenter, Randomized, Single-Masked, Sham Injection-Controlled Exposure-Response Study of Lampalizumab Intravitreal Injections Administered Every Two Weeks or Every Four Weeks to Patients With Geographic Atrophy

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 96 (actual)
• Sponsor: Genentech, Inc. · Industry
• Sex: All
• Age: 60 Years
• Healthy volunteers: Not accepted

Summary

This multicenter, randomized, single-masked, sham injection-controlled study will investigate the exposure-response and safety of lampalizumab administered intravitreally every 2 weeks (Q2W) or every 4 weeks (Q4W) for 24 weeks in participants with geographic atrophy (GA) secondary to age-related macular degeneration (AMD). A safety run-in assessment will be conducted prior to initiating enrollment in the randomized study.

Conditions

• Geographic Atrophy

Interventions

Type	Name	Description
OTHER	Sham	Sham injection will be administered as a matching intravitreal injection of lampalizumab.
DRUG	Lampalizumab	10 mg dose of lampalizumab administered intravitreally

Timeline

• Start date: 2015-03-30
• Primary completion: 2017-06-02
• Completion: 2017-06-02
• First posted: 2014-11-11
• Last updated: 2019-09-25
• Results posted: 2019-02-19

Locations

36 sites across 1 country: United States

Regulatory

• FDA-regulated drug study