[ITAP - 6-month results of a prospective, randomised phase 3 study for evaluation of the combination therapy of PDT and intravitreal triamcinolone in exudative AMD]. / ITAP - 6-Monats-Ergebnisse einer prospektiven und randomisierten Phase-3-Studie zur Evaluation der Kombinationstherapie aus PDT und intravitrealem Triamcinolon bei der exsudativen AMD.
Klin Monbl Augenheilkd
; 226(1): 60-5, 2009 Jan.
Article
en De
| MEDLINE
| ID: mdl-19173165
ABSTRACT
BACKGROUND:
Combination therapy of photodynamic therapy (PDT) with intravitreal triamcinolone (IVTA) for choroidal neovascularisation (CNV) in age-related macular degeneration is thought to improve the prognosis. It is therefore widely used, although results are mostly based upon non-randomised and retrospective studies. Here we present the 6-month results of our prospective, randomised, multicentre ITAP trial (Intravitreal Triamcinolone and PDT) for the evaluation of the combination therapy as compared to PDT alone. PATIENTS This prospective, randomised, multicentre phase III trial was performed for the evaluation of the efficacy and safety of combination therapy (PDT and IVTA) as compared to PDT alone. Three randomised therapy groups (A PDT alone, B IVTA on the same day 1 hour after PDT C IVTA 1 week before PDT) were monitored over 1 year. The patients included had wet AMD with predominantly classic CNV, minimal classic CNV smaller than 4 papillary diameters or occult CNV with recent disease progression. Re-treatment was performed when persistent leakage of the CNV was visible at follow-up. Primary outcome criteria were the comparison between combination therapy and PDT monotherapy concerning visual acuity, and, second, the comparison between the two groups of combination therapy.RESULTS:
92 patients were included in the study. Before treatment, mean best corrected ETDRS letter score was 52, 53 and 51 in groups A, B and C, respectively. At the 6 months follow-up, mean best corrected letter score was 40, 47 and 47, respectively, with only group A loosing more than 10 letters. This change, however, was not statistically significant between the groups. Mean retinal thickness as measured with optical coherence tomography decreased in all groups, and reached statistical significance in both combination groups. Re-treatment rates did not differ significantly between the three groups at 6 months follow-up, nor was there a significant cataract progression requiring operation.CONCLUSION:
At 6 months there was no significant difference between mono- and combination therapy groups concerning visual acuity.
Texto completo:
1
Banco de datos:
MEDLINE
Asunto principal:
Fotoquimioterapia
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Triamcinolona
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Neovascularización Coroidal
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Degeneración Macular
Tipo de estudio:
Clinical_trials
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Observational_studies
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Prognostic_studies
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Risk_factors_studies
Límite:
Aged
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Aged80
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Female
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Humans
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Male
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Middle aged
Idioma:
De
Revista:
Klin Monbl Augenheilkd
Año:
2009
Tipo del documento:
Article