Verteporfin photodynamic therapy for neovascular age-related ...

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138 Appendix 1There are many different types of CNV. Two of the types of CNV,namely classic or predominantly classic CNV, cause extremelyrapid and severe sight loss. Results from a clinical trial carriedout in 22 different countries suggest that a treatment calledphotodynamic therapy may slow down or stop the sight loss inclassic or predominantly classic CNV.This treatment, called PDT for short, has been made available onthe NHS for those people who have been diagnosed as havingclassic or predominantly classic CNV. Your retina specialist willtell you if you fall into these categoriesWHAT IS THE STUDY I AM BEING ASKED TO TAKE PARTIN?The study is called the verteporfin photodynamic therapy cohortstudy, or VPDT cohort study for short. Although PDT has beenapproved for use in the NHS, the NHS needs to know thecondition of patients’ eyes before treatment and the results ofthe treatment. The cohort study is designed to do this.The cohort study is not a trial of a new treatment. All personsfound to have subfoveal classic and predominantly classic CNVare being offered treatment on the NHS. For the purposes of thestudy we simply wish to have access to the information on youreye condition in order to assess the value of PDT treatment overtime. In addition, if you agree, we may ask you to completequestionnaires which help us to assess the impact of sight losson your ability to carry out usual, day-to-day activities and thecosts you incur, or the costs incurred by relative or friends, forexample when you come to hospital apppointments. The datawill be entered into a secure computer and will includeinformation on your eyesight, details of the clinical andphotographic examination and relevant medical history.Information will be collected at every visit. Your personal detailsare confidential and only designated people such as the doctorsand nurses involved in your care will have access to this. If youexperience any side effects from the treatment, we are obliged toinform the company and/or the Health Authorities. This will bedone without giving them any details that might enable them to
DOI: 10.3310/hta16060Health Technology Assessment 2012; Vol. 16: No. 6139know your name. We will inform your GP that you are taking partin the cohort study as long as you have no objections to us lettingyour GP know.WHAT IS PHOTODYNAMIC THERAPY AND HOW IS ITPERFORMED ?The treatment uses a special drug called verteporfin (marketedunder the name of visudyne), which sensitises the blood vesselsso that they can be destroyed using a low energy laser.Visudyne is injected into the bloodstream and when there isenough visudyne in the body, a specially designed laser isfocused on the retina through a contact lens placed on the eye.The whole process should cause little or no discomfort.Because the drug is mainly concentrated in the abnormal bloodvessels these are preferentially destroyed and further leakageand bleeding is reduced. The surrounding normal blood vesselsare also damaged but the damage is minimal and they recoververy rapidly. The retina itself does not take up the drug and sodoes not become damaged although it is exposed to the laser.The treatment is performed by ophthalmologists who havespecialised in treating retinal disorders.The abnormal damaged vessels may recover and this is why thetreatment may have to be repeated several times. You will needto come back every 3 months to have further photographstaken of the back of your eye, and whenever the abnormalblood vessels leak again, you will need another treatment. Thismay happen up to 4 times per year. Many patients havealready been on treatment for up to 2 years. Although initiallyyou will be asked to return every 3 months to see your eyespecialist, he or she may reduce the frequency of these visits ifyour eye condition stabilises. We expect this to happen around1 year after treatment is started.WHY IS THE VPDT COHORT STUDY BEING DONE?PDT is a treatment which has been available for use since 2000but which has only recently been approved for use in the NHS.The clinical trials which tested this treatment showed that patientswho received the active treatment lost less vision (measured by© 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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66 Discussion of resultsStrengths a
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84 References16. Stelmack J. Qualit
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86 References49. Guymer RH, Chiu AW
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Page 104 and 105: 90 Appendix 1THE VERTEPORFIN PHOTOD
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FeedbackThe HTA programme and the a
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