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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01602120
First Posted: May 18, 2012
Last Update Posted: September 14, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Genentech, Inc.
  Purpose
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).

Condition Intervention Phase
Geographic Atrophy Drug: Lampalizumab Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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

Further study details as provided by Genentech, Inc.:

Primary Outcome Measures:
  • Percentage of Participants (Enrolled From Study CFD4870g) With Ocular and Non-Ocular Adverse Events (AEs) [ Time Frame: From Day 1 up to approximately 96 months ]
  • Percentage of Participants (Enrolled From Study GX29455) With Ocular and Non-Ocular AEs [ Time Frame: From Day 1 up to approximately 54 months ]

Secondary Outcome Measures:
  • Serum Concentrations of Lampalizumab [ Time Frame: From Day 1 up to approximately 96 months (for participants enrolled from study CFD4870g); From Day 1 up to approximately 54 months (for participants enrolled from study GX29455) ]

Enrollment: 159
Actual Study Start Date: May 29, 2012
Estimated Study Completion Date: March 28, 2022
Estimated Primary Completion Date: June 29, 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lampalizumab Monthly: Study CFD4870g
Participants will receive lampalizumab 10 milligrams (mg) ITV injection monthly starting at Day 1 for up to 42 (18 + 24) months. The study treatment period has been extended by another 24 months and again by additional 30 months for a total treatment period of 96 months.
Drug: Lampalizumab
Lampalizumab 10 mg ITV injections as per the schedule specified in respective arms.
Other Name: FCFD4514S
Experimental: Lampalizumab Every Other Month: Study CFD4870g
Participants will receive lampalizumab 10 mg ITV injection every other month starting at Day 1 for up to 18 months. The treatment duration has been extended by 24 months and participants have been crossed over to monthly treatment arm to receive monthly lampalizumab treatment for the remainder of study treatment period. The study treatment period has been extended by another 24 months and again by additional 30 months for a total treatment period of 96 months.
Drug: Lampalizumab
Lampalizumab 10 mg ITV injections as per the schedule specified in respective arms.
Other Name: FCFD4514S
Experimental: Lampalizumab Monthly: Study GX29455
Participants will receive lampalizumab 10 mg ITV injection monthly starting at Day 1 for up to 54 ITV injections.
Drug: Lampalizumab
Lampalizumab 10 mg ITV injections as per the schedule specified in respective arms.
Other Name: FCFD4514S

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years to 89 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  • 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 patient at high risk for treatment complications
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01602120


  Show 46 Study Locations
Sponsors and Collaborators
Genentech, Inc.
Investigators
Study Director: Clinical Trials Genentech, Inc.
  More Information

Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT01602120     History of Changes
Other Study ID Numbers: GX28198
2012-000578-41 ( EudraCT Number )
First Submitted: May 16, 2012
First Posted: May 18, 2012
Last Update Posted: September 14, 2017
Last Verified: September 2017

Additional relevant MeSH terms:
Atrophy
Geographic Atrophy
Pathological Conditions, Anatomical
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Immunoglobulin Fab Fragments
Immunologic Factors
Physiological Effects of Drugs