Christine Aroney1, Samantha Fraser-Bell1, Ecosse L Lamoureux2, Mark C Gillies1, Lyndell L Lim3, Eva K Fenwick4. 1. The Save Sight and Eye Health Institute, Sydney Medical School, University of Sydney, Sydney, New South Wales, Australia. 2. The Centre for Eye Research, University of Melbourne, Royal Victoria Eye and Ear Hospital, Melbourne, Australia 3Singapore Eye Research Institute, National University of Singapore, Singapore 4Duke-NUS Medical School, Singapore. 3. The Centre for Eye Research, University of Melbourne, Royal Victoria Eye and Ear Hospital, Melbourne, Australia. 4. The Centre for Eye Research, University of Melbourne, Royal Victoria Eye and Ear Hospital, Melbourne, Australia 3Singapore Eye Research Institute, National University of Singapore, Singapore.
Abstract
PURPOSE: To determine the patient-centered 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 center-involving diabetic macular edema (DME). METHODS: Patients with DME 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. Vision-related quality of life 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 analyzed using t-tests to assess changes over time. RESULTS: Forty-eight patients completed the main study; 43 (90%) answered the IVI at the baseline and 24-month (final efficacy) visits. Vision-related quality of life 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 with 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 DME over a 24-month period. (Clinicaltrials.gov identifier NCT01298076).
PURPOSE: To determine the patient-centered 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 center-involving diabetic macular edema (DME). METHODS: Patients with DME 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. Vision-related quality of life 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 analyzed using t-tests to assess changes over time. RESULTS: Forty-eight patients completed the main study; 43 (90%) answered the IVI at the baseline and 24-month (final efficacy) visits. Vision-related quality of life 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 with 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 DME over a 24-month period. (Clinicaltrials.gov identifier NCT01298076).
Authors: Patricia Udaondo; Alfredo Adan; Luis Arias-Barquet; Francisco J Ascaso; Francisco Cabrera-López; Verónica Castro-Navarro; Juan Donate-López; Alfredo García-Layana; Francisco Javier Lavid; Mariano Rodríguez-Maqueda; José María Ruiz-Moreno Journal: Clin Ophthalmol Date: 2021-07-27