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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
96
Sham injection will be administered as a matching intravitreal injection of lampalizumab.
10 mg dose of lampalizumab administered intravitreally
Change From Baseline in Geographic Atrophy (GA) Area, as Assessed by Fundus Autofluorescence (FAF) at Week 24
GA or the death of photoreceptors and surrounding cells in the retina, is a common condition in participants with age-related macular degeneration (AMD). The death of these photoreceptors results in lesions that cause vision loss. The change in GA lesion area was measured by FAF and analysis of FAF images was performed by the central reading center. A positive change from baseline indicates an increase in size of geographic atrophy lesion area (worsening; disease progression). BCVA=best corrected visual acuity; ETDRS=Early Treatment Diabetic Retinopathy Scale.
Time frame: Baseline, Week 24
Serum Concentrations of Lampalizumab (Q2W)
Lower than reportable (LTR) results on pre-dose sample were set to 0, and LTR results on post-dose sample were set to half of lower limit of quantification (LLOQ) (0.5 nanograms per milliliter (ng/mL)).
Time frame: Baseline (Day 1, predose and postdose), Weeks 2,4,8,16 and 24, early termination, unscheduled predose and postdose
Serum Concentrations of Lampalizumab (Q4W)
LTR results on pre-dose sample were set to 0, and LTR results on post-dose sample were set to half of LLOQ (0.5 ng/mL).
Time frame: Baseline (Day 1, predose and postdose), Weeks 4,8,16 and 24, early termination
Percentage of Participants With Ocular Adverse Events (AEs)
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 the events which are localized in the ocular region.
Time frame: Baseline up to approximately 30 weeks
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Barnet Dulaney Perkins Eye Center
Mesa, Arizona, United States
University of Arizona; Banner University Medical, Department of Opthalmology
Tucson, Arizona, United States
Northwest Arkansas Retina Associates
Springdale, Arkansas, United States
Retinal Diagnostic Center
Campbell, California, United States
The Retina Partners
Encino, California, United States
Loma Linda University
Loma Linda, California, United States
San Diego Retina Associates
Oceanside, California, United States
West Coast Retina Medical Group
San Francisco, California, United States
California Retina Consultants
Santa Barbara, California, United States
Colorado Retina Associates, PC
Golden, Colorado, United States
...and 26 more locations
Percentage of Participants With Systemic (Non-ocular) Adverse Events
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. Non-ocular AEs were the systemic events.
Time frame: Baseline up to approximately 30 weeks
Percentage of Participants With Anti-Lampalizumab Antibodies
Having treatment-induced anti-drug antibodies (ADAs) was defined as being ADA-negative at baseline and ADA-positive at any post-baseline timepoint. Having treatment-enhanced ADAs was defined as being ADA-positive at baseline with titer values increased by 0.6 titer units at any post-baseline timepoint.
Time frame: Baseline up to approximately 30 weeks