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Comparison of early retreatment with the standard regimen in verteporfin therapy of neovascular age-related macular degeneration.

Author(s): Michels S, Wachtlin J, Gamulescu MA, Heimann H, Prunte C, Inhoffen W, Krebs I, Schmidt-Erfurth U

Affiliation(s): Klinik fur Augenheilkunde und Optometrie, Medizinische Universitat Wien, Vienna, Austria.

Publication date & source: 2005-12, Ophthalmology., 112(12):2070-5. Epub 2005 Oct 12.

Publication type: Clinical Trial, Phase III; Multicenter Study; Randomized Controlled Trial

PURPOSE: To compare the efficacy and safety of early retreatment with verteporfin therapy with that of approved standard verteporfin therapy in neovascular age-related macular degeneration. DESIGN: Prospective, randomized, multicenter clinical trial. PARTICIPANTS: Two hundred three patients with predominantly classic choroidal neovascularization secondary to age-related macular degeneration. METHODS: Throughout the first 6 months of follow-up, patients received retreatment with verteporfin therapy either every 2 months (group A) or 3 months (group B). From 6 to 12 months, both groups received retreatment at 3-month intervals. MAIN OUTCOME MEASURES: The primary outcome of the study was best-corrected mean visual acuity as measured using the Early Treatment Diabetic Retinopathy Study protocol. The secondary outcomes were percentage of patients losing at least 3 lines of vision, percentage of patients gaining at least 1 line of vision, and lesion size based on the greatest linear dimension (GLD) documented by fluorescein angiography, impact of initial lesion size, and retreatment rate as well as safety. RESULTS: Visual acuity was similar in both groups at baseline with a mean visual acuity of 20/100(-1). During the 12 months of follow-up, mean visual acuity was better in the early retreatment group at all intervals; however, no statistically significant benefit was seen in the overall population at any time (P>0.1). At month 12, mean visual acuity was 20/160(+1) in group A and 20/160(-1) in group B. There was a trend for better outcomes in the early retreatment group with regard to loss of less than 3 lines of vision at 12 months (61% vs. 51.7%). No statistically significant difference was seen with regard to lesion size for either group throughout follow-up with a final GLD of the lesion of 2790 microm (group A) and 2996 microm (group B). However, subgroup analysis indicated a statistically relevant benefit (P< or =0.004) for patients with small lesions (GLD<2000 microm) at baseline receiving early retreatment. CONCLUSIONS: Early retreatment in 2-month intervals did not show a significant overall benefit at 1 year of follow-up compared with the standard regimen. However, smaller lesions seemed to benefit from early retreatment with verteporfin therapy in contrast to larger lesions.

Page last updated: 2006-01-31

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