Abstract

FR.13.12

ITAP – Intravitreal Triamcinolone and PDT. 6-months results of a prospective, randomised, multicenter, phase III study to evaluate the therapy of exudative AMD with PDT with or without intravitreal triamcinolone

Gamulescu M. A.¹, Schubert K.¹, Wiechens B.², Spital G.³, Stroux A.⁴, Wachtlin J.⁴ für die ITAP-Studien-Gruppe
¹Klinik und Poliklinik für Augenheilkunde, Klinikum der Universität, Regensburg; ²Klinik für Augenheilkunde, Klinikum Region Hannover Nordstadt, Hannover; ³Augenklinik am St. Franziskus-Hospital, Münster; ⁴Augenklinik, Charité - Universitätsmedizin Berlin, Campus Benjamin Franklin, Berlin

Objective: Combination therapy of photodynamic therapy (PDT) with intravitreal triamcinolone (IVT) for choroidal neovascularization in age-related macular degeneration is thought to improve prognosis. It is therefore widely used, although results are mostly based upon non-randomized and retrospective studies. Here we present the 6-months results of our multicenter ITAP-trial for the evaluation of combination therapy as compared to PDT alone.
Methods: Prospective, randomised, multicenter phase III trial for the evaluation of efficacy and safety of the combination therapy (PDT and IVT) as compared to PDT alone. Three randomised therapy groups (A: PDT alone, B: IVT on the same day after PDT, C: IVT 1 week before PDT) are monitored over 1 year. Patients included have wet AMD with predominantly classic CNV, minimal classic CNV smaller than 4 papillary diameters or occult CNV with recent disease progression. Re-treatment is performed when persistent leakage of the CNV is visible at follow-up. Primary outcome criteria are the comparison between combination therapy and PDT mono-therapy concerning visual acuity, and, second, the comparison between the two groups of combination therapy.
Results: 92 patients were included into the study. As of today, follow-up ranges from 6 to 12 months. Before treatment, mean best corrected ETDRS letter score was 53, 54 and 51 in groups A, B and C, respectively. At the 6 months follow-up, mean best corrected letter score was 42, 48 and 49, respectively, with only group A losing more than 10 letters. Mean retinal thickness as measured with optical coherence tomography decreased in all groups. Re-treatment rates did not differ significantly between the three groups at 3 and 6 months follow-up.
Conclusions: The 6 months follow-up data suggest that combination therapy with PDT and IVT might be indeed superior to the mono-therapy of PDT only. At 6 months, there was no significant difference between the two combination groups.

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