Portal de Periódicos da CAPES

Comparison of Early Retreatment with the Standard Regimen in Verteporfin Therapy of Neovascular Age-Related Macular Degeneration

2005; Elsevier BV; Volume: 112; Issue: 12 Linguagem: Inglês

10.1016/j.ophtha.2005.06.034

1549-4713

Stephan Michels, J Wachtlin, Maria Andreea Gamulescu, Heinrich Heimann, Christian Prünte, W. Inhoffen, Ilse Krebs, Ursula Schmidt‐Erfurth,

Retinal Development and Disorders

PurposeTo compare the efficacy and safety of early retreatment with verteporfin therapy with that of approved standard verteporfin therapy in neovascular age-related macular degeneration.DesignProspective, randomized, multicenter clinical trial.ParticipantsTwo hundred three patients with predominantly classic choroidal neovascularization secondary to age-related macular degeneration.MethodsThroughout 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 MeasuresThe 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.ResultsVisual 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 μm (group A) and 2996 μm (group B). However, subgroup analysis indicated a statistically relevant benefit (P≤0.004) for patients with small lesions (GLD<2000 μm) at baseline receiving early retreatment.ConclusionsEarly 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.