The objectives of this study were to evaluate the safety and efficacy of Zimura intravitreal (IVT) administration when administered in participants with geographic atrophy (GA) secondary to dry age-related macular degeneration (AMD).
Participants will receive monthly intravitreal injections of Zimura or Sham for 18 months.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
286
Avacincaptad Pegol 20 mg/mL solution for intravitreal (IVT) injection
The Sham procedure included the blunt opening of an empty, needleless syringe barrel placed on the conjunctiva in the inferotemporal quadrant of the eyeball to simulate the pressure of an injection.
Change From Baseline in Geographic Atrophy as Measured by Fundus Autofluorescence
The least squares mean change in geographic atrophy (GA) from baseline to Month 12 was measured by fundus autofluorescence (FAF). The square root of the GA area was used in the analysis. Per statistical analysis plan, only the Zimura 2 mg and 4 mg groups were evaluated for this primary endpoint; the Zimura 1 mg group was for descriptive purposes only.
Time frame: Baseline and 12 months
Change From Baseline in Best Corrected Visual Acuity Using Early Treatment Diabetic Retinopathy Study Letters
The least squares mean change in best-corrected visual acuity (BCVA) from baseline to Month 12 was measured using early treatment diabetic retinopathy study \[ETDRS\] letters. Per statistical analysis plan, only the Zimura 2 mg and 4 mg groups were evaluated for the secondary endpoints; the Zimura 1 mg group was for descriptive purposes only.
Time frame: Baseline and 12 months
Change From Baseline in Low Luminance BCVA Using Early Treatment Diabetic Retinopathy Study Letters
The least squares mean change in low luminance (LL) BCVA from baseline to Month 12 was measured using ETDRS letters. Per statistical analysis plan, only the Zimura 2 mg and 4 mg groups were evaluated for the secondary endpoints; the Zimura 1 mg group was for descriptive purposes only.
Time frame: Baseline and 12 months
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Unnamed facility
Phoenix, Arizona, United States
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Tucson, Arizona, United States
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Tucson, Arizona, United States
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Campbell, California, United States
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Fresno, California, United States
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Fullerton, California, United States
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La Jolla, California, United States
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Mountain View, California, United States
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Redlands, California, United States
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Sacramento, California, United States
...and 68 more locations