Macular Degeneration Clinical Trial
Official title:
A Phase IIa, Safety and Preliminary Effects Study of WST11 (Stakel®) Mediated Vascular-Targeted Photodynamic (VTP) Therapy in Subjects With Choroidal Neovascularization (CNV) Associated With Age-Related Macular Degeneration (AMD)
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).
The primary objective of this Phase IIa clinical study is to evaluate the safety of treatment
with Stakel®-mediated VTP in subjects with neovascular AMD. The secondary objective of this
Phase IIa clinical study is to explore the effect of treatment with Stakel®-mediated VTP in
subjects with neovascular AMD. 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 AEs collection).
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