Clinical trial NCT01602120: An Extension Study to Evaluate the Long-Term Safety of Lampalizumab in Participants With Geographic Atrophy
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Geographic Atrophy
Lead sponsor: Genentech, Inc.
Sponsor class: INDUSTRY
First posted: 2012-05-18
Enrollment: 159
Sex: ALL
Minimum age (years): 60
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 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

Primary outcomes:
measure: Percentage of Participants With Ocular and Non-ocular Adverse Events (AEs)
timeFrame: From Day 1 up to the last study visit (up to approximately 62 months)
Secondary outcomes:
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Retina Centers P.C.
state: Arizona
city: Beverly Hills
country: United States
facility: Retina-Vitreous Assoc Med Grp
state: California
city: Campbell
country: United States
facility: Retinal Diagnostic Center
state: California
city: Encino
country: United States
facility: The Retina Partners
state: California
city: Loma Linda
country: United States
facility: Loma Linda University
state: California
city: Oceanside
country: United States
facility: San Diego Retina Associates
state: California
city: San Francisco
country: United States
facility: W Coast Retina Med Group Inc
state: California
city: San Francisco
country: United States
facility: West Coast Retina
state: California
city: Santa Barbara
country: United States
facility: California Retina Consultants
state: California
city: Torrance
country: United States
facility: Retina Macula Institute
state: California
city: Golden
country: United States
facility: Colorado Retina Associates, PC
state: Colorado
city: Boca Raton
country: United States
facility: Retina Group of Florida
state: Florida
city: Fort Myers
country: United States
facility: National Ophthalmic Research Institute
state: Florida
city: Melbourne
country: United States
facility: Florida Eye Associates
state: Florida
city: Palm Beach Gardens
country: United States
facility: Retina Care Specialists
state: Florida
city: Pensacola
country: United States
facility: Retina Specialty Institute
state: Florida
city: Winter Haven
country: United States
facility: Ctr for Retina & Macular Dis
state: Florida
city: Augusta
country: United States
facility: Southeast Retina Center
state: Georgia
city: West Des Moines
country: United States
facility: Wolfe Eye Clinic
state: Iowa
city: Baltimore
country: United States
facility: Elman Retina Group
state: Maryland
city: Boston
country: United States
facility: Ophthalmic Consultants of Boston
state: Massachusetts
city: Edina
country: United States
facility: Vitreoretinal Surgery
state: Minnesota
city: Saint Louis
country: United States
facility: The Retina Institute
state: Missouri
city: Reno
country: United States
facility: Sierra Eye Associates
state: Nevada
city: Albuquerque
country: United States
facility: Eye Associates of New Mexico
state: New Mexico
city: Lynbrook
country: United States
facility: Opthalmic Consultants of LI
state: New York
city: Asheville
country: United States
facility: Western Carolina Retinal Associate PA
state: North Carolina
city: Charlotte
country: United States
facility: Char Eye Ear &Throat Assoc
state: North Carolina
city: Beachwood
country: United States
facility: Retina Assoc of Cleveland Inc
state: Ohio
city: Cincinnati
country: United States
facility: Cincinnati Eye Institute
state: Ohio
city: Oklahoma City
country: United States
facility: Dean McGee Eye Institute
state: Oklahoma
city: Portland
country: United States
facility: Retina Northwest
state: Oregon
city: Philadelphia
country: United States
facility: Mid Atlantic Retina
state: Pennsylvania
city: Ladson
country: United States
facility: Charleston Neuroscience Institute
state: South Carolina
city: Knoxville
country: United States
facility: Southeastern Retina Associates
state: Tennessee
city: Nashville
country: United States
facility: Tennessee Retina PC
state: Tennessee
city: Abilene
country: United States
facility: W Texas Retina Consultants PA
state: Texas
city: Austin
country: United States
facility: Retina Research Center
state: Texas
city: Dallas
country: United States
facility: Texas Retina Associates
state: Texas
city: Norfolk
country: United States
facility: Wagner Macula & Retina Center
state: Virginia
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
city: Bonn
country: Germany
facility: Universitatsklinikum Bonn; Medizinische Klinik und Poliklinik III
city: Freiburg
country: Germany
facility: Universitätsklinikum Freiburg
city: Leipzig
country: Germany
facility: Universitatsklinikum Leipzig
city: Munster
country: Germany
facility: St. Franziskus Hospital
city: Tuebingen
country: Germany
facility: Universitätsklinikum Tübingen
Study officials:
affiliation: Genentech, Inc.
name: Clinical Trials
role: STUDY_DIRECTOR
References: