Verteporfin photodynamic therapy for neovascular age-related ...

DOI: 10.3310/hta16060Health Technology Assessment 2012; Vol. 16: No. 655Chapter 7Results (3) – objective EHow effective is verteporfin photodynamic therapy with respectto best-corrected monocular distance visual activity?Chapter 6 reports outcomes of VPDT in comparison with the TAP trials, that is the change inBCVA over time. As the VPDT cohort study did not have a control group, effectiveness couldbe estimated only indirectly. Although we considered three ways to do this, we were able toapply only the second method (see Chapter 4, E: How effective and cost-effective is verteporfinphotodynamic therapy?).In terms of BCVA, this method was, in effect, the comparison in change in BCVA over timereported in Chapter 6. Both the fitted trajectory and the average absolute change in BCVA overtime for patients with predominantly classic lesions in the EFT group were similar to those forpatients in the TAP treatment arm. For eyes with minimally classic lesions in the EFT group, thetrajectory of BCVA was parallel to that observed for the minimally classic subgroup of the TAPtreatment arm, but showed less absolute loss of BCVA (see Figures 7 and 8).For HRQoL outcomes, no similar comparison could be made because HRQoL data were notreported for participants in the TAP trials.How effective is verteporfin photodynamic therapy with respectto health-related quality of life?Absence of HRQoL outcome in the TAP trials was a major limitation with respect to the NICEtechnology appraisal of VPDT. Therefore, describing the change in HRQoL with treatmentwas a key objective of the study. We aimed to do this by quantifying the extent to which BCVApredicted HRQoL.The subgroup of 18 centres collected and submitted BCVA, CS and HRQoL data for 3262 visitsfor 1829 patients (Tables 13 and 14). Most data were available for visits at 0, 6 and 12 months, asplanned, but data for many patients were also available for 3 and 9 months; 53% of patients haddata for two or more visits [one visit, 47%; two visits, 33%; three visits, 16%; more than threevisits (maximum six), 4%].Generic health-related quality of lifeBest-corrected monocular distance visual acuity: in the better-seeing eye strongly predictedSF-6D, physical component score (PCS) and mental component score (MCS) (p < 0.0001 forall three HRQoL measures). For each HRQoL measure, the best-fitting models were linear. Noevidence was found to support the hypothesis of a sigmoid relationship. We also did not observeany tendency at all for gradients to decrease with the duration of follow-up. The relationshipbetween BCVA in the better-seeing eye and the SF-6D utility score is shown in Figure 13, with thefitted regression superimposed on a scatterplot of the raw data. Predicted changes in SF-6D, PCSand MCS for 5- and 100-letter reductions in BCVA are shown in Table 15.© Queen’s Printer and Controller of HMSO 2012. This work was produced by Reeves et al. under the terms of a commissioning contract issued by theSecretary of State for Health.