Long-Term Safety of Lampalizumab Intravitreal (ITV) Injections in Participants With Geographic Atrophy (GA) Secondary to Age-Related Macular Degeneration (OMASPECT)

Phase 3TerminatedNCT02745119

Hoffmann-La Roche994 enrolled

Overview

This multicenter open-label extension study is designed to evaluate the safety and tolerability of lampalizumab intravitreal injections in participants with GA secondary to age-related macular degeneration (AMD) who completed 96 weeks of treatment in Studies GX29176 (NCT02247479) or GX29185 (NCT02247531). The extension will enroll participants from the parent studies who received investigational lampalizumab, as well as lampalizumab-naive participants exposed to sham comparator. All participants will receive open-label lampalizumab in the present study.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

994

Conditions

Geographic Atrophy

Interventions

Lampalizumab

Eligibility

Sex: ALL

Medical Language ↔ Plain English

Inclusion Criteria: * Previous enrollment in Studies GX29176 (NCT02247479) or GX29185 (NCT02247531) with completion of treatment and the Week 96 visit * Agreement to remain abstinent or use a reliable form of contraception among all men and among women of child-bearing potential Exclusion Criteria: * Concurrent ocular conditions that contraindicate use of lampalizumab or might affect interpretation of study results or that might increase the risk of treatment complications * Concurrent disease, metabolic dysfunction, or physical or laboratory finding that contraindicates use of lampalizumab or might affect interpretation of study results or that might increase the risk of treatment complications * Increased risk of infection * Pregnancy or lactation

Locations (208)

Uni of Alabama At Birmingham Clinical Research Unit

Birmingham, Alabama, United States

Retinal Research Institute, LLC

Phoenix, Arizona, United States

Associated Retina Consultants

Phoenix, Arizona, United States

Retina Centers P.C.

Tucson, Arizona, United States

Retina Associates Southwest PC

Tucson, Arizona, United States

Outcomes

Primary Outcomes

Percentage of Participants With Ocular Adverse Events (AEs) by Severity

An AE was defined as any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether considered related to the medicinal product, any new disease or exacerbation of an existing disease, recurrence of an intermittent medical condition, or any deterioration in a laboratory value or other clinical test. Ocular AEs are the events which are localized in the ocular region.

Time frame: Up to approximately one year

Percentage of Participants With Systemic (Non-Ocular) AEs by Severity

Time frame: Up to approximately one year

Percentage of Participants With Anti-Lampalizumab Antibodies

The immunogenicity analysis included participants with at least one predose and one postdose anti-lampalizumab antibodies assessment. Predose was defined as prior to the first dose in the extension study for the prior sham participants, and prior to the first dose in the parent study for the prior lampalizumab participants.

Time frame: Week 48