Patient Reported Outcomes From Clinical Trials in Medical Retina

Abstract

Purpose: To determine the patient-centred effectiveness of treatment with the slow release dexamethasone intravitreal implant (DEX implant) and intravitreal bevacizumab using the Impact of Vision Impairment Questionnaire (IVI), a vision-related quality of life (VRQoL) measure, in patients with visual impairment secondary to centre-involving diabetic macular edema (DMO). Methods: Patients with DMO were enrolled in a phase 2, prospective, multicenter, randomized, single-masked clinical trial and received either DEX implant 4 monthly or bevacizumab monthly, both pro re nata. VRQoL was measured at baseline and 24 months, using the IVI’s three component scales, namely Reading, Mobility and Emotional Well-being. Rasch analysis was used to generate interval-level estimates of VRQoL, which were then analysed using t-tests to assess changes over time. Results: 48 patients completed the main study; 43 (90%) answered the IVI at the baseline and 24-month (final efficacy) visits. VRQoL improved significantly, with average increases of 1.44, 0.99 and 1.49 logits, for the Reading, Mobility and Emotional well-being scales respectively, from baseline to 24 months, (p<0.001). There was no significant between-group difference in improvement in VRQoL in the DEX implant only compared with the bevacizumab-only group, in any of the three scales listed above (with 1.41, 1.08 and 2.11 logits improvement, in Reading, Mobility and Emotional well-being respectively for DEX implant group, compared to 1.48, 1.06 and 2.11 for bevacizumab; p-values >0.1.) Conclusions: We found that both DEX implant and bevacizumab treatment result in significant and similar improvements in VRQoL in patients with DMO over a 24-month period.