Session Title: Free Paper Session 3: AMD I
Session Date/Time: Thursday 07/09/2017 | 08:30-10:00
Paper Time: 08:36
Venue: Room 118
First Author: : J.Monés SPAIN
Co Author(s): : G. Staurenghi C. Wykoff F. Tang B. Tong R. Cantrell C. Brittain
Geographic atrophy (GA) is an advanced form of age-related macular degeneration (AMD) that can lead to significant impairment of visual function and eventual blindness. Proxima A (NCT02479386) is an observational, prospective study aimed at better understanding the natural history of GA. An interim analysis of baseline (BL) patient characteristics for Proxima A is presented.
Proxima A is a prospective, observational study of patients with GA secondary to AMD and is planned to occur at up to 87 sites globally for a duration of 48 months.
Approximately 300 patients aged 50 years and over with bilateral GA and without choroidal neovascularization are being enrolled at 87 global sites. Patients will be divided into complement factor I (CFI)-profile genetic biomarker-positive or -negative groups and will be evaluated for up to 48 months at 6 month intervals. The primary outcome measure is GA lesion size evaluated by fundus autofluorescence imaging. Key secondary outcomes include visual function characteristics evaluated by best-corrected visual acuity (BCVA), monocular reading speed, and patient-reported outcomes (PROs) including the NEI Visual Function Questionnaire (VFQ-25) and Functional Reading Independence (FRI) Index.
The planned interim analysis on August 11, 2016 evaluated BL characteristics of all patients enrolled at that time (N=173). The mean age was 78.1 years, over half (59%) of patients were female, and nearly all (98%) were white. Forty-nine percent of patients were positive for the CFI-profile biomarker. The mean BL GA area was 8.07 mm2 and the mean number of years since first GA diagnosis was 4.2 years. Mean BL BCVA was 66.6 ETDRS letters, while mean BL maximum monocular reading speed was 69 wpm. Mean PRO scores were 68.0 out of 100 and 2.8 out of 4.0 for the NEI VFQ-25 and FRI Index, respectively.
Baseline demographic and disease characteristics were consistent with expectations per study enrollment criteria. Baseline visual function data demonstrate the presence of significant functional deficits, highlighting the severity of GA and its impact on quality of life. Future analyses of Proxima A data are planned to continue to advance the understanding of the natural history of GA.