Development of a risk score for geographic atrophy in complications of the age-related macular degeneration prevention trial

Abstract

Objective: To develop a risk score for developing geographic atrophy (GA) involving easily obtainable information among patients with bilateral large drusen.

Design: Cohort study within a multicenter randomized clinical trial.

Participants: We included 1052 participants with ≥ 10 large (>125 μm) drusen and visual acuity ≥ 20/40 in each eye.

Methods: In the Complications of Age-related Macular Degeneration (AMD) Prevention Trial (CAPT), 1 eye of each participant was randomly assigned to laser treatment and the contralateral eye was assigned to observation to evaluate whether laser treatment of drusen could prevent vision loss. Gradings by a reading center were used to identify: CAPT end point GA (total area of GA [>250 μm] > 1 disc area), GA (>175 μm) involving the foveal center (CGA), and GA of any size and location (any GA). Established risk factors (age, smoking status, hypertension, Age-related Eye Disease Study simple severity scale score), both with and without a novel risk factor (night vision score), were used in assigning risk points. The risk scores were evaluated for the ability to discriminate and calibrate GA risk.

Main outcome measures: Development of end point GA, CGA, and any GA.

Results: Among 942 CAPT participants who completed 5 years of follow-up and did not have any GA at baseline, 6.8% participants developed CAPT end point GA, 9.6% developed CGA, and 34.4% developed any GA. The 5-year incidence of end point GA in 1 or both eyes of a participant increased with the 15-point GA risk score, from 0.6% for <7 points to 15% for ≥ 12 points. The 5-factor risk score predicted development of GA moderately well with the area under the receiver operating characteristic curve (AUC) 0.76 (95% confidence interval [CI], 0.71-0.81) for end point GA; 0.76 (95% CI, 0.71-0.80) for CGA, and 0.68 (95% CI, 0.65-0.72) for any GA. Prediction from the risk score without the night vision score had lower AUCs (range, 0.67-0.72).

Conclusions: If validated in other patients, the GA risk score will be useful for identifying high-risk patients for clinical trials of prevention of GA and for clinical assessment of GA risk in early AMD patients.