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

September 10, 2019 updated by: Genentech, Inc.

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

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).

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

159

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Bonn, Germany, 53127
        • Universitatsklinikum Bonn; Medizinische Klinik und Poliklinik III
      • Freiburg, Germany, 79106
        • Universitätsklinikum Freiburg
      • Leipzig, Germany, 04103
        • Universitatsklinikum Leipzig
      • Munster, Germany, 48145
        • St. Franziskus Hospital
      • Tuebingen, Germany, 72076
        • Universitätsklinikum Tübingen
  • United States
    • Arizona
      • Tucson, Arizona, United States, 85704
        • Retina Centers P.C.
    • California
      • Beverly Hills, California, United States, 90211
        • Retina-Vitreous Assoc Med Grp
      • Campbell, California, United States, 95008
        • Retinal Diagnostic Center
      • Encino, California, United States, 91436
        • The Retina Partners
      • Loma Linda, California, United States, 92354
        • Loma Linda University
      • Oceanside, California, United States, 92056
        • San Diego Retina Associates
      • San Francisco, California, United States, 94107
        • W Coast Retina Med Group Inc
      • San Francisco, California, United States, 94107
        • West Coast Retina
      • Santa Barbara, California, United States, 93103
        • California Retina Consultants
      • Torrance, California, United States, 90503
        • Retina Macula Institute
    • Colorado
      • Golden, Colorado, United States, 80401
        • Colorado Retina Associates, PC
    • Florida
      • Boca Raton, Florida, United States, 33431
        • Retina Group of Florida
      • Fort Myers, Florida, United States, 33912
        • National Ophthalmic Research Institute
      • Melbourne, Florida, United States, 32901
        • Florida Eye Associates
      • Palm Beach Gardens, Florida, United States, 33410
        • Retina Care Specialists
      • Pensacola, Florida, United States, 32503
        • Retina Specialty Institute
      • Winter Haven, Florida, United States, 33880
        • Ctr for Retina & Macular Dis
    • Georgia
      • Augusta, Georgia, United States, 30909
        • Southeast Retina Center
    • Iowa
      • West Des Moines, Iowa, United States, 50266
        • Wolfe Eye Clinic
    • Maryland
      • Baltimore, Maryland, United States, 21237
        • Elman Retina Group
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Ophthalmic Consultants of Boston
    • Minnesota
      • Edina, Minnesota, United States, 55435
        • VitreoRetinal Surgery
    • Missouri
      • Saint Louis, Missouri, United States, 63128
        • The Retina Institute
    • Nevada
      • Reno, Nevada, United States, 89502
        • Sierra Eye Associates
    • New Mexico
      • Albuquerque, New Mexico, United States, 87102
        • Eye Associates of New Mexico
    • New York
      • Lynbrook, New York, United States, 11563
        • Opthalmic Consultants of LI
    • North Carolina
      • Asheville, North Carolina, United States, 28803
        • Western Carolina Retinal Associate PA
      • Charlotte, North Carolina, United States, 28210
        • Char Eye Ear &Throat Assoc
    • Ohio
      • Beachwood, Ohio, United States, 44122
        • Retina Assoc of Cleveland Inc
      • Cincinnati, Ohio, United States, 45242
        • Cincinnati Eye Institute
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73099
        • Dean McGee Eye Institute
    • Oregon
      • Portland, Oregon, United States, 97221
        • Retina Northwest
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Mid Atlantic Retina
    • South Carolina
      • Ladson, South Carolina, United States, 29456
        • Charleston Neuroscience Institute
    • Tennessee
      • Knoxville, Tennessee, United States, 37923
        • Southeastern Retina Associates
      • Nashville, Tennessee, United States, 37203
        • Tennessee Retina PC
    • Texas
      • Abilene, Texas, United States, 79606
        • W Texas Retina Consultants PA
      • Austin, Texas, United States, 78705
        • Retina Research Center
      • Dallas, Texas, United States, 75231
        • Texas Retina Associates
    • Virginia
      • Norfolk, Virginia, United States, 23451
        • Wagner Macula & Retina Center
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Medical College of Wisconsin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years to 89 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Drug: Lampalizumab
Lampalizumab 10 mg ITV injections as per the schedule specified in respective arms.
Other Names:
  • FCFD4514S
Experimental: CFD4870g Lampalizumab
Participants will receive lampalizumab 10 mg, ITV, Q4W or Q8W in accordance with their previously assigned treatment frequency assignment in Study NCT01229215 (CFD4870g) followed by Q4W administration for the remainder of the extension study up to approximately 96 months.
Drug: Lampalizumab
Lampalizumab 10 mg ITV injections as per the schedule specified in respective arms.
Other Names:
  • FCFD4514S
Experimental: GX29455 Sham
Participants who were administered sham comparator in Study NCT02288559 (GX29455), will receive lampalizumab 10 mg, ITV, Q4W throughout the extension study up to approximately 54 months.
Drug: Lampalizumab
Lampalizumab 10 mg ITV injections as per the schedule specified in respective arms.
Other Names:
  • FCFD4514S
Experimental: GX29455 Lampalizumab
Participants who were administered lampalizumab in Study NCT02288559 (GX29455), will receive lampalizumab 10 mg, ITV, Q4W throughout the extension study up to approximately 54 months.
Drug: Lampalizumab
Lampalizumab 10 mg ITV injections as per the schedule specified in respective arms.
Other Names:
  • FCFD4514S

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Ocular and Non-ocular Adverse Events (AEs)
Time Frame: From Day 1 up to the last study visit (up to approximately 62 months)
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 events localized to the eye. Non-ocular events include all other events.
From Day 1 up to the last study visit (up to approximately 62 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Genentech, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 29, 2012

Primary Completion (Actual)

November 8, 2017

Study Completion (Actual)

February 9, 2018

Study Registration Dates

First Submitted

May 16, 2012

First Submitted That Met QC Criteria

May 16, 2012

First Posted (Estimate)

May 18, 2012

Study Record Updates

Last Update Posted (Actual)

September 11, 2019

Last Update Submitted That Met QC Criteria

September 10, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GX28198
  • 2012-000578-41 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Geographic Atrophy

Clinical Trials on Lampalizumab

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Colombia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe