Abstract
Purpose :
The impact of missed appointments for anti-vascular endothelial growth factor (anti-VEGF) injection treatment for macular edema due to retinal vein occlusion (MERVO) on visual acuity (VA) is unknown. We performed a secondary analysis of Study of COmparative Treatments for REtinal Vein Occlusion 2 (SCORE2) data to evaluate the association between patients’ adherence to clinical trial visits and VA in patients with central retinal vein occlusion (CRVO) or hemiretinal vein occlusion (HRVO).
Methods :
The SCORE2 protocol included a visit every 4 weeks (every 28-35 days) during the first year. Visit adherence was measured as: number of missed visits, average (avg days) and longest (max days) visit interval, average (avg missed days) and longest (max missed days) unintended visit interval. Avg and max missed days were categorized as on time (0 days), late (>0-60 days), and very late (>60 days). Primary outcome was change in Early Treatment Diabetic Retinopathy Study (ETDRS) VA between baseline study visit and last attended visit during Year 1, using multivariate linear regression models controlling for baseline VA, baseline central subfield thickness, age, gender, race, ethnicity, study eye disease type, prior anti-VEGF in study eye, disease duration at baseline, history of diabetes, coronary artery disease or hypertension, whether or not patient was re-randomized at Month 6, and total number of injections.
Results :
Of the 362 patients enrolled in SCORE2, 358 were included in the study. Only 48 patients missed a visit during the initial year of follow up, and only 12 missed more than 1 visit. After adjustment, for each visit missed, patients lost 3.0 letters (95%CI: -6.2, 0.2) of vision (p=0.07). On average, the 48 patients who missed at least 1 visit lost 9.4 letters (95%CI: -14.4, -4.3, p<0.001) of vision after adjustment. Average days and maximal interval between visit were not associated with changes in VA (p>0.22) for both comparisons). However, when a visit was missed, the average missed days between missed visits and the max missed interval were both associated with loss of VA (both variables: 0 days missed as reference, late [1-60 days] -10.8 letters [95%CI: -16.9, -4.7], very late [>60 days] -7.3 letters [95%CI: -14.5, -0.2]; p=0.003 for both). See Table 1 for additional results.
Conclusions :
Visit adherence is associated with VA outcomes during Year 1 in SCORE2 participants.
This abstract was presented at the 2022 ARVO Annual Meeting, held in Denver, CO, May 1-4, 2022, and virtually.