Session Title: Vascular Diseases I
Session Date/Time: Friday 27/09/2013 | 08:00-10:00
Paper Time: 09:36
Venue: Hall C (Level 1)
First Author: W.Amoaku UK
Co Author(s): R. Gale A. Lotery G. Menon S. Sivaprasad
To evaluate patient-reported treatment satisfaction and general well-being outcomes from patients in the REPAIR Study of the efficacy and safety of ranibizumab in myopic choroidal neovascularization (mCNV).
Patients enrolled in the phase II, open-label, multicentre, 12-month REPAIR Study (NCT01037348) were assessed at 12 UK clinical sites.
The REPAIR Study enrolled 65 participants with active primary or recurrent subfoveal or juxtafoveal mCNV. Patients received intravitreal ranibizumab 0.5 mg at baseline and pro re nata (PRN) during the 12-month study period (mean, 3.6 injections). In addition to assessment of best corrected visual acuity (BCVA) and clinical measures, an exploratory objective of the study was to evaluate the effects of ranibizumab on patient-reported outcomes. Treatment satisfaction was measured using the 13-item Macular Disease Treatment Satisfaction Questionnaire (MacTSQ; scores range from 0 to 72), which includes two subscales, impact of treatment, and information provision and convenience. Well-being was assessed using the 12-item Well-Being Questionnaire (W-BQ12; scores range from 0 to 36), which produces measures of negative well-being, positive well-being and energy as well as a composite general well-being score. Patients completed the W-BQ12 at baseline, and both instruments at months 1, 6 and 12 (MacTSQ, 62, 59 and 61 patients, respectively; W-BQ12, 59, 61 and 61 patients). Subgroup analyses investigated patients treated in their better-seeing eye (BSE) or worse-seeing eye (WSE); receiving 1, 2–3 or > 3 injections; and with baseline BCVA of < 52, 53–67, or > 68 letters. Results are presented as means [standard deviations].
From baseline to month 12, mean BCVA improved by 13.8 [14.0] letters (p < 0.001). The overall MacTSQ score increased from 55.0 [17.9] at month 1 to 58.8 [16.2] at month 6 and 64.9 [9.2] at month 12 (p = 0.005 and 0.0001, respectively). At month 12, both BSE and WSE groups had improvements of 9.5–10.0 points. Patients receiving 1 injection reported scores of 64.3 [8.1] at month 1, compared with 51.9 [20.5] and 53.5 [18.1] for those requiring 2–3 injections or > 3 injections, respectively. At month 12, satisfaction remained high for patients receiving 1 injection (64.5 [13.8]), and patients receiving 2–3 or > 3 injections reported increases of 14.0 [19.7] and 10.7 [18.5] points, respectively. At month 1, patients with baseline BCVA < 52 letters reported higher mean MacTSQ scores than the 53–67 or > 68 letter subgroups (59.2 [15.2] vs 51.7 [19.7] and 55.1 [18.5], respectively); all BCVA subgroups reported increases of 8.7–11.0 points to month 12. Similar results were observed for both subscales. At month 12, patients had significantly higher W-BQ12 general well-being scores compared with baseline (27.3 [6.4] vs 25.6 [7.0], p = 0.03) and numerical improvements in all subscales.
Based on these exploratory analyses, the MacTSQ results show that patients with mCNV treated with ranibizumab PRN for up to 12 months experience high overall treatment satisfaction. Patients with low BCVA at baseline report the highest treatment satisfaction levels at month 12. Analysis of MacTSQ subscales suggests that changes over the study period may be driven by the information provision and convenience score. A modest but statistically significant improvement from baseline in general well-being was also observed over the study period.