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Results of an Effectiveness Study

Sanjay Sharma, MD, MSc(Epid), MBA; Jeff Bakal, MSc; Alejandro Oliver-Fernandez, MD, MSc; Jason Blair, BSc, MBA

Arch Ophthalmol. 2004;122:853-856.

Objective  To determine the postapproval effectiveness of photodynamic therapy (PDT) with verteporfin for the treatment of predominantly classic subfoveal choroidal neovascularization (CNV) secondary to age-related macular degeneration.

Methods  Forty-five consecutive patients treated with PDT for subfoveal CNV were compared with an untreated historical control group. Control patients had subfoveal CNV and were first seen by us within 1 year before Health Canada's approval of verteporfin. Both groups were followed up for the development of significant visual loss, stability, or improvement. Multivariate models were constructed to evaluate the effectiveness of PDT, controlling for multiple covariates (age, sex, baseline visual acuity, follow-up time, lesion size, and number of treatments).

Results  Significant differences were noted in the change in visual acuity between those who did and did not receive PDT (² = 5.9, P = .048). Patients who received PDT were 2.9 times (95% confidence interval, 0.9-9.1) less likely to develop a moderate (>2 lines) visual loss (² = 3.2, P = .07). Controlling for covariates, patients who received PDT were 13.7 times (95% confidence interval, 1.4-132.6) more likely to develop a visual improvement of at least 1 line.

Conclusion  Compared with historical controls, PDT was demonstrated to be effective for the treatment of predominantly classic subfoveal CNV.

From the Departments of Epidemiology and Ophthalmology (Dr Sharma) and Mathematics and Statistics (Mr Bakal), Queen's University, and the Cost-Effective Ocular Health Policy Unit, Hotel Dieu Hospital (Drs Sharma and Oliver-Fernandez and Messrs Bakal and Blair), Kingston, Ontario. The authors have no relevant financial interest in this article.