Abstract
To evaluate the impact of reduction in geographic atrophy (GA) lesion growth on visual acuity in the GATHER trials using categorical outcome measures.
Randomized, double-masked, sham-controlled phase 3 trials.
Aged ≥50 years with non-center point involving GA and best corrected visual acuity (BCVA) of 25-80 Early Treatment Diabetic Retinopathy Study (ETDRS) letters in the study eye.
GATHER1 consisted of 2 parts. In Part 1, 77 patients were randomized 1:1:1 to avacincaptad pegol (ACP) 1 mg, ACP 2 mg, and sham. In Part 2, 209 patients were randomized 1:2:2 to ACP 2 mg, ACP 4 mg, and sham. In GATHER2, patients were randomized 1:1 to ACP 2 mg (n=225) and sham (n=223). A post hoc analysis of 12-month data for pooled ACP 2 mg and sham groups is reported.
Proportion of study eyes that experienced ≥10-, ≥15-, or ≥20-BCVA ETDRS letter loss from baseline to month 12; time-to-event analysis of persistent vision loss of ≥10-, ≥15-, or ≥20-BCVA letters from baseline at ≥2 consecutive visits over 12 months; proportion of study eyes with BCVA loss to a level below driving eligibility threshold at month 12 among those eligible to drive at baseline.
Lower proportions of study eyes experienced ≥10-, ≥15-, or ≥20-BCVA letter loss from baseline over 12 months with ACP 2 mg (11.6%, 4.0%, and 1.6%, respectively) vs sham (14.1%, 7.6%, and 4.5%, respectively). There was a reduction in the risk of persistent loss of ≥15-BCVA ETDRS letters with ACP 2 mg (3.4%) vs sham (7.8%) through 12 months. A lower proportion of study eyes treated with ACP 2 mg reached the threshold for driving ineligibility vs sham by 12 months.
Treatment with ACP 2 mg delayed the risk of progression to persistent vision loss (ie, ≥10-, ≥15-, and ≥20-BCVA letter loss or BCVA loss to a level below driving eligibility threshold) vs sham over 12 months.