drugset / Trial / NCT01021956

Safety and Preliminary Efficacy Study of WST11 (Stakel®)-Mediated VTP Therapy in Subjects With CNV Associated With AMD

NCT01021956 ↗

Phase 2 Terminated 10 enrolled Steba Biotech S.A.
NaSingle-groupOpen-labelTreatment

Summary

The objectives of this study are to evaluate the safety(first objective) and efficacy(second objective)of an experimental drug product,Stakel®, in the treatment of neovascular Age related Macular Degeneration (AMD). The drug product is activated in patients by exposure to light at a specific wavelength ("Vascular Targeted Photodynamic therapy", "VTP"). The exploratory objective is to assess whether it is possible to delay or reduce the requirement for anti Vascular Endothelium Growth Factor (anti VEGF) intravitreal therapy in the first 12 weeks after VTP. All subjects will have a 52 weeks safety follow up telephone call (Not for Adverse Events (AEs) collection).

Timeline

Start
2010-06
Primary completion
2012-05
Completion
2014-01

Outcome

Outcome not reported

Stopped: “Retinal vascular occlusion in 2 patients”

Drugs

EvaluationDrugModalityDoseRoute
Subject Padeliporfin Other / unclassified 2.5 mg/kg —