Authors' objectives:

To update a previous CAHTA systematic review with regard to the effectiveness and safety of photodynamic therapy in the treatment of age-related macular (AMD).

Authors' results and conclusions: No new randomised controlled trials have been identified; just new analysis and new follow-up results from TAP randomised studies (Treatment of Age-related Macular Degeneration with Photodynamic Therapy) and VIP randomised studies (Verteporfin in Photodynamic Therapy), selected in the previous review. Most of these new reports including new outcomes (composition and size of the lesion and contrast sensitivity). In addition we found one systematic review carried out by Cochrane Collaboration and a consensus document on the use of photodynamic therapy and verteporfin conducted by experts from different countries under the guidance of diverse scientific societies. The results and conclusions from the subgroup analysis and exploratory analyses of the samples in the TAP and VIP studies have been taken cautiously. In general, these analyses have not been specified in the initial protocol of the study nor have they been taken into account in the design and calculation of the patient sample. In the majority of these studies, patients are treated verteporfin with no control and in open-label fashion. The overall analysis of the TAP and VIP studies shows a combined relative risk (RR) of losing 3 or more lines of visual acuity of 0.80 [95% confidence interval (CI) 0.70-0.91] after one year of treatment and 0.77 (95% CI 0.69-0.87) after 2 years, according to the meta-analysis conducted by the Cochrane Collaboration. Slightly more favourable results are observed when measuring the loss of 6 or more lines of visual acuity and the relative risk of losing was 0.62 (95% CI 0.50-0.76) after two years of follow-up. As regards the analysis of subgroups, patients with evidence of occult choroidal neovascularisation (CNV) are found to have a RR of losing 3 or more lines of visual acuity per year of 0.90 (95% CI 0.73-1.11) and 0.34 (95% CI 0.22-0.51) if occult CNV was absent. These differences are maintained at 2 years. Taking into account the area of a classic CNV lesion (composed of classic component only), the lesions that responded most favourably to treatment were: the predominantly classic lesion [RR of losing 3 or more lines of visual acuity was 0.54 (95% CI 0.41?0.79) at 1 year and 0.60 (95% CI 0.48?0.75) at 2 years] and occult lesion with no classic component at 2 years with about 5.5 treatments in total [RR of losing 3 or more lines of vision was 0.77 (95% CI 0.64?0.92)]. Overall, the number needed to treat (NNT) to prevent 1 person from loosing 3 or more lines of vision was 6.9 and 7.1 for the loss of 6 or more lines of vision after 2 years in both cases. With regard to quality of life outcomes, it should be said that none of the randomised trials (TAP and VIP) measured the impact of treatment as per HRQoL instruments. Nonetheless, two studies have been identified, with no comparison group that analysed HRQoL in patients with classic CNV or predominantly classic CNV, observing decreased anxiety and higher level of independence in treated patients after 12 months of follow-up. Patients presented a mild subjective benefit of visual acuity from treatment and in some cases this subjective impression did not correlate with the clinical outcome validated after the treatment. In general, photodynamic therapy with verteporfin is well tolerated by the patients, even though one out of four patients may present transitory visual alterations during the first few days following treatment.

Authors' recommendations: The available scientific evidence suggests that photodynamic therapy can be effective and safe in preventing visual loss in patients with predominantly classic subfoveal CNV and occult CNV with no classic component caused by AMD and when the neovascular process is active. So far, the size of the lesion does not appear to be totally established and the exact significance of the efficacy results observed (visual acuity and contrast sensitivity) is unknown in terms of HRQoL. Precise and careful patient selection is recommended prior to the treatment and when the neovascular process is active. Likewise, the aim should be to try and reduce as much as possible the time between diagnosis and patient treatment, to apply photodynamic therapy by ophthalmologists experienced in the diagnosis and treatment of macular disease, to create unit specialising in macular disease with a fast patient referral, and to increase the current public availability of the treatment to reduce waiting lists in centres with a consolidated experience in macular pathology. Finally, robust studies are needed to assess the improvement of HRQoL in patients treated with verteporfin and the correlation between visual acuity and HRQoL.

Authors' methods: Systematic review

Project Status: Completed

URL for project: http://www.gencat.net/salut/depsan/units/aatrm/html/en/dir393/doc7921.ht ml

Year Published: 2006

English language abstract: An English language summary is available

Publication Type: Not Assigned

Country: Spain

Organisation Name: Agencia de Qualitat i Avaluacio Sanitries de Catalunya

Contact Address: Antoni Parada, CAHTA, Roc Boronat, 81-95 (2nd floor), 08005 Barcelona, Spain, Tel. +34 935 513 928, Fax: +34 935 517 510

Contact Name: direccio@aatrm.catsalut.net / aparada@aatrm.catsalut.net

Contact Email: direccio@aatrm.catsalut.net / aparada@aatrm.catsalut.net

Copyright: Catalan Agency for Health Technology Assessment and Research (CAHTA)