Extrait

The primary objective is to assess the safety of the same-day administration of photodynamic therapy with Visudyne® and an intravitreal injection of RFB002 (ranibizumab). Safety of the combined treatments will be assessed with visual acuity measurements and ophthalmic examinations, as well as an evaluation of adverse events and vital signs. The primary variable for this assessment is the incidence of severe vision loss, i.e. the number of patients who lose >30 letters in best corrected visual acuity (BCVA) from baseline, beginning within 14 days of the combination treatment and persisting for longer than 14 days.

Critère d'inclusion

• Male and female patients > 50 years of age with subfoveal choroidal neovascularization (CNV) secondary to AMD

Liens

• ictrp
• euctr