RESPONSIVENESS OF THE NATIONAL EYE INSTITUTE VISUAL FUNCTION QUESTIONNAIRE-25 TO VISUAL ACUITY GAINS IN PATIENTS WITH DIABETIC MACULAR EDEMA: Evidence From the RIDE and RISE Trials

Abstract

Purpose: To evaluate the responsiveness of the National Eye Institute Visual Function Questionnaire-25 (NEI VFQ-25) in patients with diabetic macular edema using data from the RIDE and RISE trials.

Methods: Patients were randomized to monthly intravitreal ranibizumab 0.3 mg, 0.5 mg, or sham injections for 2 years. The NEI VFQ-25 was administered at baseline and at Months 6, 12, 18, and 24. The least-squares mean change in NEI VFQ-25 for ≥15 letters gained or lost was derived from analysis of covariance models.

Results: The mean improvement in NEI VFQ-25 composite score associated with a ≥15-letter gain in best-corrected visual acuity over 24 months was 9.0 (95% confidence interval, 6.3-11.7) points in RIDE and 7.1 (95% confidence interval, 4.7-9.6) points in RISE. In patients who lost ≥15 letters, the mean worsening in overall NEI VFQ-25 composite score was -6.6 (95% confidence interval, -13.6 to 0.5) in RIDE and -2.7 (95% confidence interval, -8.9 to 3.5) in RISE.

Conclusion: This exploratory analysis of data from the RIDE and RISE studies supports the responsiveness of the NEI VFQ-25 to changes in best-corrected visual acuity over time in patients with diabetic macular edema.

Fig. 1.

Least-squares mean change from baseline to Month 24 in NEI VFQ-25 by best-corrected visual acuity in RIDE and RISE: All eyes. LS, least squares. *Analysis of covariance–adjusted for baseline NEI VFQ-25 score, gender, and age. Pooled treatment groups include sham, ranibizumab 0.3 mg, and ranibizumab 0.5 mg; RIDE, n = 380; RISE, n = 374. Vertical bars represent the 95% CIs of the mean.

Fig. 2.

Least-squares mean change from baseline to Month 24 in NEI VFQ-25 in patients who gained ≥15 Early Treatment Diabetic Retinopathy Study letters (RIDE/RISE pooled data). LS, least squares. Analysis of covariance–adjusted for baseline NEI VFQ-25 score, gender, and age. Vertical bars represent the 95% CIs of the mean.