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

Roche

Status and phase: Terminated; Phase 3

Conditions: Geographic Atrophy

Treatments: Drug: Lampalizumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT02745119

2016-000423-13 (EudraCT Number)

GX30191

Details and patient eligibility

About

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.

Enrollment: 994 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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994 participants in 2 patient groups

Lampalizumab Every 4 Weeks

Experimental group

Description:

Participants who received either lampalizumab or sham comparator every 4 weeks in one of the parent studies and completed the Week 96 visit will receive open-label lampalizumab as 10 milligrams (mg) via ITV injection, administered every 4 weeks.

Treatment:

Drug: Lampalizumab

Lampalizumab Every 6 Weeks

Experimental group

Description:

Participants who received either lampalizumab or sham comparator every 6 weeks in one of the parent studies and completed the Week 96 visit will receive open-label lampalizumab as 10 mg via ITV injection, administered every 6 weeks.

Treatment:

Drug: Lampalizumab