| Contributors: |
A. M., K; S. S., P; G., S; R., T; C. J., D; D. A., E; J., H; C. C., W; J. S., H; D. R., L; J., M; J. S., N; V. S., S; P. K., K; J., C; L., Z; H., P; J., T; D., D; G. J., J; A., A; A. A., F; J., B; S., B; J., Lp; M., S; M., V; C., Z; F., F; A., C; E. E. G., C; T., N; O., F; A., H; M., K; S., S; L. D., P; M., F; M., M; M., N; F., A; M., B; M., D; J., G; A., K; A., M; M. M., L; F., R; J., E; K., K; K., N; Y., C; C., C; F., Db; F., D; C., F; L., K; J. F., K; Y., Lm; M., Qem; S., R; E., S; M., W; N., E; N., F; S., G; P., W; R., L; K., L; S., P; T., K; C., J; C. P., L; A., P; A., S; E., T; A., T; A., V; B., V; G., V; A., B; E., E; D., H; J., L; N., M; H., M; I., R; O., T; F., B; A. P., C; F., G |
| Description: |
background geographic atrophy is an advanced form of dry age-related macular degeneration that can lead to irreversible vision loss and high burden of disease. we aimed to assess efficacy and safety of avacincaptad pegol 2 mg in reducing geographic atrophy lesion growth. methods GATHER2 is a randomised, double-masked, sham-controlled, 24-month, phase 3 trial across 205 retina clinics, research hospitals, and academic institutions globally. to be eligible, patients had to be aged 50 years or older with non-centrepoint-involving geographic atrophy and best corrected visual acuity between 20/25 and 20/320 in the study eye. eligible patients were randomly assigned (1:1) to monthly avacincaptad pegol 2 mg administered as a 100 mu L intravitreal injection or sham for the first 12 months. randomisation was performed using an interactive response technology system with stratification by factors known to be of prognostic importance in age-related macular degeneration. patients, investigators, study centre staff, sponsor personnel, and data analysts were masked to treatment allocation. the primary endpoint was geographic atrophy lesion size measured by fundus autofluorescence at baseline, month 6, and month 12. efficacy and safety analyses were done in the modified intention-to-treat and safety populations, respectively. this trial is registered with clinical trials.gov, NCT04435366.findings between June 22, 2020, and July 23, 2021, 1422 patients were screened for eligibility, of whom 448 were enrolled and randomly assigned to avacincaptad pegol 2 mg (n=225) or sham (n=223). one patient in the sham group did not receive study treatment and was excluded from analyses. there were 154 (68%) female patients and 71 (32%) male patients in the avacincaptad pegol 2 mg group, and 156 (70%) female patients and 66 (30%) male patients in the sham group. from baseline to month 12, the mean rate of square-root-transformed geographic atrophy area growth was 0 center dot 336 mm/year (SE 0 center dot 032) with avacincaptad pegol 2 mg and ... |