| Titre | The use of microplasmin in vitreoretinal surgery: a phase II clinical trial |
| Abstract Nr. | 184 |
| But | Enzymatic induction of a posterior vitreous detachment may be beneficial in enhancing vitrectomy for vitreomacular interface disorders. At present, only autologous plasmin is known to be a relative safe drug for this purpose. However, isolation of this enzyme is a tedious process and is not standardized. Microplasmin is a recombinant enzyme derived from human plasmin. The aim of this phase II multi-centric study is to evaluate the clinical use and possible side-effects of microplasmin injected intravitreally before vitrectomy. |
| Méthodes | 60 patients will be included with vitreomacular traction (idiopathic or diabetic) or macular hole (stages II or III). The drug is injected in variable dosage and at different time intervals before the surgery (6 cohorts). Clinical results and possible side-effects are evaluated before the surgery and up to 6 months after the surgery using ophthalmic examination, funduscopy, angiography, electrophysiology and OCT. |
| Résultats | At present, 16 patients are included in the study. No serious side effects related to the injected microplasmin have been reported. |
| Nom | STALMANS |
| Initiales | P |
| Institut | UZLeuven |
| Ville | Leuven |
| Nom | Feron |
| Initiales | E |
| Institut | Eye Hospital Rotterdam |
| Ville | Rotterdam, The Netherlands |
| Nom | Gandorfer |
| Initiales | A |
| Institut | Dept of Ophthalmology, Ludwig Maximilians University |
| Ville | Munich, Germany |
| Nom | Kampik |
| Initiales | A |
| Institut | Dept of Ophthalmology, Ludwig Maximilians University |
| Ville | Munich, Germany |
| Nom | De Smet |
| Initiales | MD |
| Institut | Academic Medical Center |
| Ville | Amsterdam, The Netherlands |