Verteporfin photodynamic therapy for neovascular age-related ...

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50 Results (2) – objectives A, B, C and DEyes classified as IFT presented with better BCVA (+1.4 letters; see Table 12) than EFT eyes withpredominantly or minimally classic CNV; UNC eyes also presented with better BCVA (+1.5letters) than EFT eyes and deteriorated more slowly (+1.50 + 0.77 = +2.3 letters at 1 year; seeTable 12); these eyes were UNC because there were no corresponding independently gradedFA findings, and so, by definition, they had unknown lesion percentages classified as classicand occult. Eyes with occult only lesions (a subgroup of IFT eyes) were better by +3.4 letters atbaseline and were observed to deteriorate more slowly (+3.43 + 2.79 = +6.2 letters at 1 year).D: Is verteporfin photodynamic therapy safe when provided in the NHS?The analysis was carried out on the cohort of patients who were treated at any time, that isn = 7748 (see Figure 5). This larger cohort was used to address objective D because ARs and AEswere collected at all visits and did not require patients to have achieved a particular duration offollow-up. If a patient had only one treatment, then an AR documented at the time of treatmentor at a subsequent follow-up visit was considered relevant. Despite defined fields in the databaseand on the data collection form provided (see Figure 2), and a stated requirement in the manualof operations that these fields should be completed at all visits, information about ARs and AEswas often missing. For example, question 8 (‘Has there been an AE since the last visit or an AR atthis visit?’) was often not completed or, when one of these fields was ticked ‘yes’, the specific AR/AE form was not completed.The analysis of safety was complex because both ARs (at the time of treatment) and AEs(documented at the subsequent visit and attributed to the previous treatment) could in principlebe either ‘systemic’, affecting the whole patient, or ‘ocular’, affecting a particular eye. However,ARs tended to be systemic (e.g. systemic AR = back pain, a known side effect of VPDT and an ARthat was documented in the TAP trials) and AEs tended to be ocular (e.g. ocular AE = drop inBCVA > 20 letters within 7 days of treatment or intraretinal haemorrhage).The cohort of 7748 patients had a total of 31,640 visits documented. Treatment was administeredat 17,809 (56.3%) visits. ARs and AEs were reported infrequently, with total numbers of216 (1.2%) and 253 (1.4%) respectively. The distributions of ARs and AEs by visit (with AEsattributed to the previous treatment visit) are shown in Figures 9 and 10. The high frequencyof ARs and AEs associated with the first treatment is, to some extent, explained by the fact thatthe number of patients having a first treatment was higher than the number of patients having asubsequent visit. However, the proportion of treated visits at which ARs and AEs were reported/attributed declined from a maximum of 1.4% and 2.0%, respectively, for visit 1 to 0.3 and 0.9%,respectively, by visit 4 with no ARs or AEs being reported beyond visit 8. Thus, an AR or AEwas much more likely to be reported or attributed to visit 1 than to subsequent visits. Therefore,analysis focused only on ARs and AEs reported at visit 1 because treatments on visit 1 were mostnumerous and most likely to be representative of the reference population of patients who wereeligible for VPDT.The proportion of first treatment visits at which an AR was reported varied from 0% to 7.8%across centres (Figure 11); the overall proportion was 1.4% [exact 95% confidence interval(CI) 1.2% to 1.6%]. Back pain was documented in 86 of 7748 first treatments (1.1%); 58% ofthese reactions were mild, 27% moderate and 15% severe. Pain at the injection site (n = 2) andextravasation (n = 1) were rarely reported. Fifteen centres (albeit with relatively few documentedtreatment visits) reported no AR.We were concerned about the compliance of centres with reporting ARs and, consequently, thedanger of underestimating the risk of an AR. For comparison, the probability of an AR in the
DOI: 10.3310/hta16060Health Technology Assessment 2012; Vol. 16: No. 651150152125Number of ARs100755050250238 9 70 1 2 3 4 5 6 7 8 9 10Visit4FIGURE 9 Distribution of all ARs over time since eyes were first treated.150125109Number of AEs10075505234250130 1 2 3 4 5 6 7 8 9 10Visit62FIGURE 10 Distribution of all AEs over time since eyes were first treated.centre with the most documented treatment visits (1603) was 2.6% (exact 95% CI 1.8% to 3.5%).ARs were reported less frequently than in the TAP trials in which, for example, back pain wasdocumented in association with 2.2% of VPDT treatment administrations, photosensitivityreactions with 3.0% and ‘adverse events at the site of injections’ 3 with 13.4% (compared with 3.4%for sham treatments).Ocular AEs were also reported infrequently. The proportion of first treatment visits at which anAE was reported varied from 0% to 14.3% across centres (Figure 12); the overall proportion was2.0% (exact 95% CI 1.7% to 2.2%). AEs included a sudden fall in vision reported by the patientor a documented loss of ≥ 20 letters within 7 days of treatment in 25 of 7748 first treatments(0.3%), a tear of the retinal pigment epithelium in 5 (0.1%) and diverse other AEs in 121 (1.6%).© 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.
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DOI: 10.3310/hta16060Health Technol
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xExecutive summaryretreat on criter
Page 14 and 15: xiiExecutive summaryof data, with i
Page 16 and 17: 2 Introductionon-going or new clini
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Page 34 and 35: 20 Key changes to the protocolThese
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Page 52 and 53: 38 Results (1) - study cohortTABLE
Page 60 and 61: 46 Results (2) - objectives A, B, C
Page 80 and 81: 66 Discussion of resultsStrengths a
Page 82 and 83: 68 Discussion of resultsThe VPDT st
Page 84 and 85: 70 Discussion of resultsOur analyse
Page 86 and 87: 72 Discussion of resultsA further c
Page 88 and 89: 74 Discussion of resultsVPDT. It is
Page 98 and 99: 84 References16. Stelmack J. Qualit
Page 100 and 101: 86 References49. Guymer RH, Chiu AW
Page 102 and 103: 88 References83. Margrain TH. Minim
Page 104 and 105: 90 Appendix 1THE VERTEPORFIN PHOTOD
Page 106 and 107: 92 Appendix 11. Overview of Manual
Page 108 and 109: 94 Appendix 1And, if also collectin
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Page 112 and 113: 98 Appendix 12.4 Limitations of the
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100 Appendix 1Box 2 Key advantages
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102 Appendix 14. Study population4.
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104 Appendix 15. Recruitment to the
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106 Appendix 16. Background data co
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108 Appendix 1Table 1: Schedule of
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110 Appendix 1The Verteporfin Photo
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112 Appendix 1• Additional clinic
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114 Appendix 18. Recording adverse
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116 Appendix 1level of benefit from
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118 Appendix 1• comparison of num
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120 Appendix 110.6 Sub-group analys
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122 Appendix 112. Data issues12.1 D
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124 Appendix 113. Organisation13.1
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126 Appendix 114. References[1] Ref
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128 Appendix 1Barnes RM, Gee L, Tay
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130 Appendix 1Appendix 1: Classifyi
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132 Appendix 1Liverpool re-treatmen
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134 Appendix 1Service StructurePlea
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136 Appendix 1Has your photographer
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138 Appendix 1There are many differ
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140 Appendix 1testing on vision tes
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142 Appendix 1something to do with
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144 Appendix 1College of Ophthalmol
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146 Appendix 1Appendix 5:Protocol f
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148 Appendix 16.2 Subjective Refrac
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150 Appendix 1• The patient shoul
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152 Appendix 1Appendix 6:Protocol f
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154 Appendix 18. It is customary to
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156 Appendix 1Early or Transit Phas
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158 Appendix 1
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166 Appendix 1Appendix 9:Site imple
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170 Appendix 1Dos and Don’tsDosDo
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172 Appendix 1Resource use question
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174 Appendix 1Appendix 11: Recommen
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176 Appendix 1ADVERSE REACTION AND
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178 Appendix 1acute Trust; note tha
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180 Appendix 1Ophthalmologistrespon
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192 Appendix 3manufacturer’s pers
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FeedbackThe HTA programme and the a
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