Verteporfin photodynamic therapy for neovascular age-related ...
Verteporfin photodynamic therapy for neovascular age-related ... Verteporfin photodynamic therapy for neovascular age-related ...
8 Methods■■■■letters when measured with an Early Treatment Diabetic Retinopathy Study (ETDRS)distance visual acuity chart (see Outcomes).Choroidal neovascularisation must be wholly or predominantly classic (i.e. ≥ 50% of theentire lesion must consist of classic CNV).Patients with subfoveal CNV due to nAMD or any other disorder are eligible for inclusion inthe VPDT study.All patients referred for assessment at a VPDT clinic in a designated treatment centre, whethereligible or not, made up the reference population. As part of the assessment, the ophthalmologistin charge of the patient made a decision on eligibility for treatment (above). There were no apriori exclusion criteria for people in the reference population. Participating hospitals were askedto submit a full set of data at the screening visit for all ineligible patients seen in person at theVPDT clinic, together with the FA used for decision-making, irrespective of whether the FA wascarried out by the participating centre or by a referring hospital.The study population consisted of all patients treated with VPDT at participating centresirrespective of CNV aetiology. (The decision whether or not to include all patients treated withVPDT, irrespective of aetiology, was made by the SCGs.) Participants were asked to give writteninformed consent for the collection of data and use of these data for the research.Treatment with verteporfin photodynamic therapyParticipating centres were requested to classify CNV as had been done in previous RCTs 3,5,34 inorder to decide whether or not patients were eligible for treatment (Table 1).Participating centres were also requested to review patients at 3-month intervals, carrying outophthalmological and angiographic examinations to determine whether or not repeat therapywas needed. Two algorithms to guide retreatment decisions were included in the study manual(Figure 1 and Table 2). Investigators were also referred to the retreatment criteria developed by aninternational expert consensus group, the Verteporfin Round Table. 37OutcomesThe primary outcome was defined as BCVA, measured on a logMAR scale using the ETDRSdistance visual acuity chart. 38Secondary outcomes included:(a) safety, that is adverse reactions (ARs) and AEs(b) contrast sensitivity (CS) measured with the Pelli–Robson chart at 1 m 39(c) generic HRQoL measured using the Short Form questionnaire-36 items (SF-36), 40 fromwhich SF-6D scores were also derived 13(d) vision-specific HRQoL measured using the NEIVFQ 11(e) independently graded morphological changes in treated lesions, that is total lesion size, totalCNV leakage, classic leakage and fibrosis(f) health and social services (HSS) resource use measured using a custom-designedquestionnaire administered to patients at the time of hospital visits for treatment or review.Collecting data to characterise ARs and AEs was an important objective of the study because, atthe outset, there was concern that such events experienced in licensing trials of VPDT may not
DOI: 10.3310/hta16060Health Technology Assessment 2012; Vol. 16: No. 69TABLE 1 Method for determining the category of CNV from stereoscopic FAs to help in the assessment of suitability ofpatients for treatment with VPDT according to the NICE recommendations issued in 2003 6A. Identify morphological featuresUse stereos of colour and angiographic frames to assist inrecognition of the following lesion components B. Assess total lesion size C. Categorise lesion subtype1. CNV lesion componentsFluorescein leakage associated with CNV■■Classic CNV■■Occult CNV: fibrovascular PED; late leakage of undeterminedoriginFeatures contiguous to CNV which prevent determination of theextent of leakage and which therefore constitute part of the lesion■■■■■■BloodElevated blocked fluorescence not due to blood (may be dueto RPE hyperplasia, thick exudate, fibrous tissue)Serous PED2. Other features associated with CNV which are NOT used to definethe boundaries of the lesion■■■■■■■■Atrophy: GA and non-GAFlat blocked fluorescenceFibrosis not contiguous to CNV boundaryThick exudate not contiguous to CNV boundary3. Other features which help with categorisation of CNV or whichmay modify natural history■■■■■■Retinal angiomatous proliferationChorioretinal anastamosesIdiopathic polypoidal choroidopathy1. Define the boundaries of thelesion2. Define the boundaries of thearea of classic leakage3. Estimate proportion of classicrelative to total lesion size4. Ineligible for photodynamictherapy if < 50% of lesionis CNV1. Classic with no occult(NICE FAD 1.1)1A. Classic leakage accounts for100% of lesion1B. Classic leakage accounts for50–99%, but lesion has no occultcomponent2. Predominantly classic with occult(NICE FAD 1.2)Classic leakage accounts for50–99% of lesion with someoccult3. Minimally classicClassic leakage accounts for< 50% of the lesion4. Occult with no classicClassic is 0%. Any CNV leakageis of the occult varietyGA, geographic atrophy; PED, pigment epithelial detachment; RPE, retinal pigment epithelium.The decision tree describes terminology from grading centres involved in TAP, VIP and Subfoveal Radiotherapy Study RCTs. 3,35,36(a)Belfast retreatment criteriaIs leakage present on FA?NoYesDo not treat and arrange review for 3 monthsIs leakage reduced when compared with pre-treatment?YesNoRetreat with PDTHas there been a treatmentrelatedAE?YesNoYesIs VA within six lines of last treatment?NoNo furthertherapyIf acute loss noted after treatment do not retreatFIGURE 1 Example of flow chart for making retreatment decisions – Belfast retreatment criteria. VA, visual activity.© 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 Technology Assessment 2012; Vol. 16: No. 69TABLE 1 Method <strong>for</strong> determining the category of CNV from stereoscopic FAs to help in the assessment of suitability ofpatients <strong>for</strong> treatment with VPDT according to the NICE recommendations issued in 2003 6A. Identify morphological featuresUse stereos of colour and angiographic frames to assist inrecognition of the following lesion components B. Assess total lesion size C. Categorise lesion subtype1. CNV lesion componentsFluorescein leak<strong>age</strong> associated with CNV■■Classic CNV■■Occult CNV: fibrovascular PED; late leak<strong>age</strong> of undeterminedoriginFeatures contiguous to CNV which prevent determination of theextent of leak<strong>age</strong> and which there<strong>for</strong>e constitute part of the lesion■■■■■■BloodElevated blocked fluorescence not due to blood (may be dueto RPE hyperplasia, thick exudate, fibrous tissue)Serous PED2. Other features associated with CNV which are NOT used to definethe boundaries of the lesion■■■■■■■■Atrophy: GA and non-GAFlat blocked fluorescenceFibrosis not contiguous to CNV boundaryThick exudate not contiguous to CNV boundary3. Other features which help with categorisation of CNV or whichmay modify natural history■■■■■■Retinal angiomatous proliferationChorioretinal anastamosesIdiopathic polypoidal choroidopathy1. Define the boundaries of thelesion2. Define the boundaries of thearea of classic leak<strong>age</strong>3. Estimate proportion of classicrelative to total lesion size4. Ineligible <strong>for</strong> <strong>photodynamic</strong><strong>therapy</strong> if < 50% of lesionis CNV1. Classic with no occult(NICE FAD 1.1)1A. Classic leak<strong>age</strong> accounts <strong>for</strong>100% of lesion1B. Classic leak<strong>age</strong> accounts <strong>for</strong>50–99%, but lesion has no occultcomponent2. Predominantly classic with occult(NICE FAD 1.2)Classic leak<strong>age</strong> accounts <strong>for</strong>50–99% of lesion with someoccult3. Minimally classicClassic leak<strong>age</strong> accounts <strong>for</strong>< 50% of the lesion4. Occult with no classicClassic is 0%. Any CNV leak<strong>age</strong>is of the occult varietyGA, geographic atrophy; PED, pigment epithelial detachment; RPE, retinal pigment epithelium.The decision tree describes terminology from grading centres involved in TAP, VIP and Subfoveal Radio<strong>therapy</strong> Study RCTs. 3,35,36(a)Belfast retreatment criteriaIs leak<strong>age</strong> present on FA?NoYesDo not treat and arrange review <strong>for</strong> 3 monthsIs leak<strong>age</strong> reduced when compared with pre-treatment?YesNoRetreat with PDTHas there been a treatment<strong>related</strong>AE?YesNoYesIs VA within six lines of last treatment?NoNo further<strong>therapy</strong>If acute loss noted after treatment do not retreatFIGURE 1 Example of flow chart <strong>for</strong> making retreatment decisions – Belfast retreatment criteria. VA, visual activity.© 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 <strong>for</strong> Health.
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