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An Extension Study to Evaluat...

An Extension Study to Evaluate the Long-Term Safety of Lampalizumab in Participants With Geographic Atrophy

Last Updated: 2019-09-11

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

159 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-05-29

Study Completion Date

2018-02-09

Brief Summary

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This is a multicenter, open-label extension study of safety and tolerability of lampalizumab administered by intravitreal (ITV) injection to participants with geographic atrophy (GA) who have completed the 18-month treatment in Study CFD4870g (GX01456) (NCT01229215) or 24-week treatment in Study GX29455 (NCT02288559).

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Detailed Description

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Conditions

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Geographic Atrophy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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CFD4870g Sham

Participants who were administered sham comparator in Study NCT01229215 (CFD4870g), will receive lampalizumab 10 milligrams (mg), intravitreally (ITV), either once in every 4 weeks (Q4W) or once in every 8 weeks (Q8W) in accordance with their previously assigned treatment frequency assignment in Study CFD4870g followed by Q4W administration for the remainder of the extension study up to approximately 96 months.

Group Type EXPERIMENTAL