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

• Status: Terminated
• Trial end date: 2018-02-09
• Target enrollment: 0
• Participant gender: All

Summary

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Genentech, Inc.

Criteria

Inclusion Criteria:

• For CFD4870g participants: Previous enrollment and completion (Month 18 visit) of Study CFD4870g without early treatment discontinuation (lampalizumab or sham)

• For GX29455 participants: Previous enrollment and completion (Week 24 visit) of Study GX29455 without early treatment discontinuation (lampalizumab or sham)

• Sufficiently clear ocular media, adequate pupillary dilation, and fixation to permit quality fundus imaging

Exclusion Criteria:

• Early treatment and/or study discontinuation prior to completion of study CFD4870g (GX01456) and GX29455

• Vitrectomy surgery, submacular surgery, or other surgical intervention for age-related macular degeneration (AMD) in the study eye

• Subfoveal focal laser photocoagulation in the study eye

• Treatment with Visodyne, external-beam radiation therapy, or transpupillary thermotherapy in the study eye

• Intravitreally (ITV) drug delivery (e.g., ITV corticosteroid injection, anti-angiogenic drugs, anticomplement drugs, or device implantation) in the study eye. Lampalizumab in study eye and ranibizumab in either eye are permitted

• Any concurrent ocular or intraocular condition in the study eye that contraindicates the use of an investigational drug or may affect interpretation of the study results or may render the participant at high risk for treatment complications