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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2017 by Genentech, Inc.
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.
ClinicalTrials.gov Identifier:
NCT01602120
First received: May 16, 2012
Last updated: May 10, 2017
Last verified: May 2017

May 16, 2012
May 10, 2017
May 31, 2012
June 30, 2019   (Final data collection date for primary outcome measure)
  • Percentage of Participants (Enrolled From Study CFD4870g) With Ocular and Non-Ocular Adverse Events (AEs) [ Time Frame: From Day 1 up to approximately 66 months ]
  • Percentage of Participants (Enrolled From Study GX29455) With Ocular and Non-Ocular AEs [ Time Frame: From Day 1 up to approximately 24 months ]
Long-term safety: Incidence of adverse events [ Time Frame: 18 months ]
Complete list of historical versions of study NCT01602120 on ClinicalTrials.gov Archive Site
Serum Concentrations of Lampalizumab [ Time Frame: From Day 1 up to approximately 66 months (for participants enrolled from study CFD4870g); From Day 1 up to approximately 24 months (for participants enrolled from study GX29455) ]
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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
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).
Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Treatment
Geographic Atrophy
Drug: Lampalizumab
Lampalizumab 10 mg ITV injections as per the schedule specified in respective arms.
Other Name: FCFD4514S
  • 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 for a total treatment period of 66 months.
    Intervention: Drug: Lampalizumab
  • 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 for a total treatment period of 66 months.
    Intervention: Drug: Lampalizumab
  • Experimental: Lampalizumab Monthly: Study GX29455
    Participants will receive lampalizumab 10 mg ITV injection monthly starting at Day 1 for up to 24 ITV injections.
    Intervention: Drug: Lampalizumab
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
113
June 30, 2019
June 30, 2019   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
60 Years to 89 Years   (Adult, Senior)
No
Contact: Reference Study ID Number: GX28198 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. and Canada) global-roche-genentech-trials@gene.com
United States,   Germany
 
 
NCT01602120
GX28198
2012-000578-41 ( EudraCT Number )
Not Provided
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Not Provided
Not Provided
Genentech, Inc.
Genentech, Inc.
Not Provided
Study Director: Clinical Trials Genentech, Inc.
Genentech, Inc.
May 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP