Clinical trial NCT02288559: A Study of Lampalizumab Intravitreal Injections Administered Every Two Weeks or Every Four Weeks to Participants With Geographic Atrophy
Official title: A Phase II, Multicenter, Randomized, Single-Masked, Sham Injection-Controlled Exposure-Response Study of Lampalizumab Intravitreal Injections Administered Every Two Weeks or Every Four Weeks to Patients With Geographic Atrophy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Geographic Atrophy
Lead sponsor: Genentech, Inc.
Sponsor class: INDUSTRY
First posted: 2014-11-11
Enrollment: 96
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This multicenter, randomized, single-masked, sham injection-controlled study will investigate the exposure-response and safety of lampalizumab administered intravitreally every 2 weeks (Q2W) or every 4 weeks (Q4W) for 24 weeks in participants with geographic atrophy (GA) secondary to age-related macular degeneration (AMD). A safety run-in assessment will be conducted prior to initiating enrollment in the randomized study.


Eligibility criteria: Inclusion Criteria:

* Complement Factor I (CFI) profile biomarker-positive result
* Women of child bearing potential and men should remain abstinent or use contraceptive methods

Exclusion Criteria:

* History of vitrectomy surgery, submacular surgery, or other surgical intervention for AMD in study eye
* Previous subfoveal focal laser photocoagulation in study eye
* Laser photocoagulation in the study eye
* Prior treatment with external-beam radiation therapy or transpupillary thermotherapy in study eye
* Previous intravitreal drug administration in study eye. A single intraoperative administration of a corticosteroid during cataract surgery at least 3 months prior to screening is permitted
* Previous cell-based intraocular treatment in study eye
* Intraocular surgery in study eye
* Uncontrolled glaucoma and history of glaucoma-filtering surgery in study eye
* History of corneal transplant in study eye
* GA in either eye due to causes other than AMD
* Proliferative diabetic retinopathy in either eye
* Active or history of neovascular (wet) AMD in either eye
* History of idiopathic or autoimmune-associated uveitis, ocular or intraocular conditions, and infectious or inflammatory ocular disease
* Active uveitis and infectious conjunctivitis, keratitis, scleritis or endophthalmitis
* Previous systemic treatment with complement inhibitor and with inhibitors/modulators of visual cycle
* Previous expression vector mediated intraocular treatments
* Uncontrolled blood pressure and atrial fibrillation
* Medical conditions associated with clinically significant risk for bleeding-
* Predisposition or history of increased risk for infection
* Active malignancy within the previous 12 months except for appropriately treated carcinoma in situ of cervix, resolved non-melanoma skin carcinoma, and prostate cancer with a Gleason score of less than or equal to 6, and a stable prostate-specific antigen for greater than or equal to (\>/=) 12 months
* History of severe allergic reaction or anaphylactic reaction to a biologic agent or known hypersensitivity to any component of lampalizumab injection
* Women of child bearing potential must have a negative serum pregnancy test within 28 days prior to initiation of study treatment
* Previous participation in other studies of investigational drugs

Primary outcomes:
measure: Change From Baseline in Geographic Atrophy (GA) Area, as Assessed by Fundus Autofluorescence (FAF) at Week 24
timeFrame: Baseline, Week 24
Secondary outcomes:
measure: Serum Concentrations of Lampalizumab (Q2W)
timeFrame: Baseline (Day 1, predose and postdose), Weeks 2,4,8,16 and 24, early termination, unscheduled predose and postdose
measure: Serum Concentrations of Lampalizumab (Q4W)
timeFrame: Baseline (Day 1, predose and postdose), Weeks 4,8,16 and 24, early termination
measure: Percentage of Participants With Ocular Adverse Events (AEs)
timeFrame: Baseline up to approximately 30 weeks
measure: Percentage of Participants With Systemic (Non-ocular) Adverse Events
timeFrame: Baseline up to approximately 30 weeks
measure: Percentage of Participants With Anti-Lampalizumab Antibodies
timeFrame: Baseline up to approximately 30 weeks
Other outcomes:
Locations:
city: Mesa
country: United States
facility: Barnet Dulaney Perkins Eye Center
state: Arizona
city: Tucson
country: United States
facility: University of Arizona; Banner University Medical, Department of Opthalmology
state: Arizona
city: Springdale
country: United States
facility: Northwest Arkansas Retina Associates
state: Arkansas
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: West Coast Retina Medical Group
state: California
city: Santa Barbara
country: United States
facility: California Retina Consultants
state: California
city: Golden
country: United States
facility: Colorado Retina Associates, PC
state: Colorado
city: Boynton Beach
country: United States
facility: Florida Eye Microsurgical Inst
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: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
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: 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: 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: Cincinnati
country: United States
facility: Cincinnati Eye Institute
state: Ohio
city: Cleveland
country: United States
facility: Retina Assoc of Cleveland Inc
state: Ohio
city: Oklahoma City
country: United States
facility: Dean McGee Eye Institute
state: Oklahoma
city: Charleston
country: United States
facility: Retina Cons of Charleston
state: South Carolina
city: Columbia
country: United States
facility: Carolina Retina Center PA
state: South Carolina
city: Germantown
country: United States
facility: Charles Retina Institution
state: Tennessee
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: Dallas
country: United States
facility: Texas Retina Associates
state: Texas
city: DeSoto
country: United States
facility: Retina Specialists
state: Texas
city: Norfolk
country: United States
facility: Wagner Macula & Retina Center
state: Virginia
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: