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TERMINATEDPHASE2

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

A Multicenter, Open-Label Extension Study to Evaluate the Long-Term Safety and Tolerability of Lampalizumab (FCFD4514S) in Patients With Geographic Atrophy Who Have Completed Genentech-Sponsored Lampalizumab Studies

NCT01602120•Genentech, Inc.

View on ClinicalTrials.gov

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).

Eligibility

Age

60 - 89 years

Sex

ALL

Healthy Volunteers

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

Locations (46)

Retina Centers P.C.

Tucson, Arizona, United States

Retina-Vitreous Assoc Med Grp

Beverly Hills, California, United States

Retinal Diagnostic Center

Campbell, California, United States

The Retina Partners

Encino, California, United States

Loma Linda University

Loma Linda, California, United States

San Diego Retina Associates

Oceanside, California, United States

W Coast Retina Med Group Inc

San Francisco, California, United States

West Coast Retina

San Francisco, California, United States

California Retina Consultants

Santa Barbara, California, United States

Retina Macula Institute

Torrance, California, United States

Key Dates

Start Date

May 29, 2012

Primary Completion Date

November 8, 2017

Completion Date

February 9, 2018

Last Updated

September 11, 2019

Enrollment

159

ACTUAL participants

Conditions

Geographic Atrophy

Interventions

Lampalizumab

DRUG

A Study to Learn How Avacincaptad Pegol (Izervay™) is Used in Clinical Practice in People Who Have Geographic Atrophy

NCT06779773

Geographic AtrophyMacular Degeneration

View study

RECRUITINGPHASE2

Phase 2 Study of ADX-038 in Participants With Geographic Atrophy

NCT06990269

Geographic Atrophy Secondary to Age-related Macular Degeneration

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 11, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

A Study to Learn How Avacincaptad Pegol (Izervay™) is Used in Clinical Practice in People Who Have Geographic Atrophy

Phase 2 Study of ADX-038 in Participants With Geographic Atrophy

A Study About the Safety of ASP3021 Eye Injections and if They Help People in Japan With Vision Loss From Age-related Macular Degeneration

Study to Assess the Adverse Events and How Intravitreal ABBV-6628 Moves Through the Body of Adult Participants With Geographic Atrophy Secondary to Age-Related Macular Degeneration

A Phase IIb Randomized, Multicenter Trial of Subretinal CPCB-RPE1 in Advanced Dry AMD (Geographic Atrophy)

Phase 3, Randomized, Placebo-Controlled Study of Tinlarebant to Explore Safety and Efficacy in Geographic Atrophy