Authors' objectives:

To establish the clinical and cost-effectiveness of photodynamic therapy (PDT) for the neovascular form of wet age-related macular degeneration (AMD) relative to current practice and in relation to current licensed indications.

Authors' results and conclusions: Number and quality of studies, and direction of evidence: In the Treatment of Age-related Macular Degeneration with Photodynamic Therapy (TAP) trial there was consistent evidence at both 1 and 2 years that verteporfin PDT results in less deterioration in visual acuity in the randomised eye than placebo. The relative risk for loss of 15 letters (three lines) or more at 2 years was 0.75 (95% confidence interval (CI), 0.65 to 0.88). This effect is both statistically significant and clinically important. The Verteporfin in Photodynamic Therapy (VIP) trial showed a similar result. There is an increase in adverse events associated with verteporfin PDT. Most are minor, but sudden visual loss occurs in 1.04.4% of verteporfin PDT patients and is an effect that patients should be aware of. Summary of benefits: The balance of beneficial and disbeneficial effects measured in the included RCTs appears to favour verteporfin PDT. However, avoiding deterioration in visual acuity, does not equate directly with improving patient function and quality of life. Also, function is dependent on vision in both eyes, not just the impact of wet AMD on one eye and this needs to be taken into account. Lack of heterogeneity between the results of TAP and VIP invites re-examination of the assumption that the nature of the wet AMD neovascular lesions has as much influence on the relative effect of verteporfin PDT as is predicted on the basis of an assessment of clinical heterogeneity. Further investigation suggests the results of subgroup analyses should be treated with extreme caution and at best should be regarded as generating hypotheses requiring more research. The impact of reduced deterioration in visual acuity should be based on whole trial estimates of effect.

Authors' recommendations: There is a need to conduct a large, multicentre, publicly funded pragmatic double-blind RCT with parallel health economic evaluation to assess not just the impact of PDT on visual acuity and adverse events, but also directly measured global quality of life and survival. There is no indication of the relationship between benefits and costs where wet AMD affects the worse-seeing eye first. Treatment of wet AMD, with verteporfin, other types of PDT, and other new technologies is an area under very active investigation, so this technology should be kept under close review.

Authors' methods: Systematic review, Economic evaluation

Project Status: Completed

URL for project: http://www.hta.ac.uk/1253

Year Published: 2003

English language abstract: An English language summary is available

Publication Type: Not Assigned

Country: England, United Kingdom

Organisation Name: NIHR Health Technology Assessment programme

Contact Address: NIHR Journals Library, National Institute for Health and Care Research, Evaluation, Trials and Studies Coordinating Centre, Alpha House, University of Southampton Science Park, Southampton SO16 7NS, UK

Contact Name: journals.library@nihr.ac.uk

Contact Email: journals.library@nihr.ac.uk

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