This is a 24-month, Phase III, multicenter, randomized, double-masked, sham-injection controlled study to assess the efficacy and safety of multiple IVT injections of APL-2 in subjects with GA secondary to AMD.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
621
Complement (C3) Inhibitor
Complement (C3) Inhibitor
Subjects will receive a Sham procedure every month
Least Squares (LS) Mean Change From Baseline in Total Area of GA Lesions in the Study Eye at Month 12
The GA lesion area was measured by a quantified central reading center based on FAF images. LS mean was calculated using a mixed effect model for repeated measure (MMRM) model. Baseline was defined as the last available, non-missing observation prior to first study drug administration.
Time frame: Baseline (screening) and Month 12
LS Mean Change From Baseline in the Total Area of GA Lesions in the Study Eye at Month 24
The GA lesion area was measured by a quantified central reading center based on FAF images. LS mean was calculated using a MMRM model. Baseline was defined as the last available, non-missing observation prior to first study drug administration.
Time frame: Baseline (screening) and Month 24
Mean Change in Total Area of GA Lesions in the Study Eye Through Month 24
The mean change in GA lesion area through Month 24 was measured by assuming a piecewise linear trend in time with knots by FAF images at Months 6, 12, and 18 and was calculated using a MMRM model. Baseline was defined as the last available, non-missing observation prior to first study drug administration.
Time frame: From Baseline (screening) through Month 24
LS Mean Change From Baseline in Monocular Maximum Reading Speed of the Study Eye at Month 24
The maximum reading speed of the study eye was calculated per Minnesota Low-Vision Reading Test (MNREAD) or Radner Reading Charts user manuals, with no adjustment for reading inaccuracy. An additional step to cap resulting reading speed values at a maximum of 300 words per minute (wpm) was implemented. Maximum reading speed was calculated as the mean of the 3 highest non-zero reading speeds (or 2, or 1 value, as available), except when all wpm were calculated as 0 then the maximum reading speed was calculated as 0. LS mean was calculated using a MMRM model. Baseline was defined as the last available, non-missing observation prior to first study drug administration.
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Subjects will receive a Sham procedure every other month
Retinal Research Institute
Phoenix, Arizona, United States
Associated Retina Consultants, Ltd
Phoenix, Arizona, United States
Retina Institute of California dba Acuity Eye Grp
Arcadia, California, United States
California Retina Consultants
Bakersfield, California, United States
Retina Vitreous Associates Medical Group
Beverly Hills, California, United States
The Retina Partners
Encino, California, United States
The Gavin Herbert Eye Institute/UC Irvine
Irvine, California, United States
Northern California Retina Vitreous Associates
Mountain View, California, United States
Retina Institute of California Medical Group
Palm Desert, California, United States
Byers Eye Institute at Standford, Stanford School of Medicine
Palo Alto, California, United States
...and 131 more locations
Time frame: Baseline (screening) and Month 24
LS Mean Change From Baseline in Mean Functional Reading Independence (FRI) Index Score at Month 24
The FRI was an interviewer-administered questionnaire with 7 items on functional reading activities most relevant to GA AMD subjects. It had 1 total index score. For each FRI Index reading activity performed in the past 7 days, subjects were asked about the extent to which they required assistance beyond eyeglasses/contact lenses, including the use of low-vision aids, adjustments in the activity, or help from another subject. Mean FRI Index scores ranged from 1 (unable to do independently) to 4 (totally independent), with higher scores indicating higher functional reading independence. A negative change from baseline indicated a decrease in the FRI; disease worsening. LS mean was calculated using a MMRM model. Baseline was defined as the last available, non-missing observation prior to first study drug administration.
Time frame: Baseline (screening) and Month 24
LS Mean Change From Baseline in Normal-Luminance Best-Corrected Visual Acuity (NL-BCVA) Score of the Study Eye at Month 24
The NL-BCVA was assessed by early treatment diabetic retinopathy study (ETDRS) chart prior to dilating the eyes at a starting distance of 4 meters and ranged from 0 (least score) to 100 (best score). If the 4-meter score was \>19 letters read correctly, the visual acuity score was the sum of total letters correctly read at 4 meters plus the addition of 30. If the 4-meter score was ≤19 letters read correctly, the visual acuity score was the sum of total letters read correctly at 4 meters and total letters read correctly at the 1-meter distance. If no letters were read correctly at either the 4-meter distance or the 1-meter distance, the visual acuity score was 0. A positive change in the value indicated improvement in visual acuity. LS mean was calculated using a MMRM model. Baseline was defined as the last available, non-missing observation prior to first study drug administration.
Time frame: Baseline (screening) and Month 24