Ignite Creation Date:
2025-12-24 @ 11:35 PM
Ignite Modification Date:
2025-12-25 @ 9:24 PM
Study NCT ID:
NCT01021956
Status:
TERMINATED
Last Update Posted:
2018-09-17
First Post:
2009-11-29
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Safety and Preliminary Efficacy Study of WST11 (Stakel®)-Mediated VTP Therapy in Subjects With CNV Associated With AMD
Sponsor:
Steba Biotech S.A.
Organization:
Study Overview
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)
Status:
TERMINATED
Status Verified Date:
2018-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Retinal vascular occlusion in 2 patients
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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).
All subjects will have a 52 weeks safety follow up telephone call (Not for Adverse Events (AEs) collection).
Detailed Description:
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).
All subjects will have a 52 weeks safety follow up telephone call. (Not for AEs collection).
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: