Ignite Creation Date:
2024-05-05 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00121407
Status:
COMPLETED
Last Update Posted:
2005-07-21
First Post:
2005-07-12
Brief Title:
Visudyne in Occult VIO
Sponsor:
QLT Inc
Organization:
QLT Inc
Study Overview
Official Title:
A Randomized Placebo-Controlled Double-Masked Multicenter Phase III Study of the Effect of Visudyne Therapy in Occult With No Classic Subfoveal Choroidal Neovascularization CNV Secondary to Age-Related Macular Degeneration AMD Visudyne in Occult VIO
Status:
COMPLETED
Status Verified Date:
2005-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to demonstrate that Visudyne therapy in patients who have occult with no classic subfoveal choroidal neovascularization CNV lesions will with an acceptable safety profile significantly reduce the risk of vision loss compared with placebo sham treatment
Detailed Description:
This is a randomized placebo-controlled double masked multicenter Phase III study Patients will be stratified by study center and randomized to Visudyne therapy or placebo in a 21 ratio respectively Patients will receive either a single intravenous dose of Visudyne or placebo followed 15 minutes after the start of the infusion by light application Follow-up visits will occur every three months - 2 weeks for the duration of the study Re-treatment may be administered every three months through the Month 21 visit if evidence of CNV leakage is detected by fluorescein angiography as judged by the Investigator
At baseline and at each follow-up visit patients will undergo the following assessments ophthalmic examination best-corrected visual acuity color fundus photography and fluorescein angiography Indocyanine green ICG angiography will be conducted at baseline Month 12 and Month 24 Optical coherence tomography OCT will be done at baseline Month 3 Month 6 Month 12 and Month 24 Adverse events and concomitant medications will be assessed throughout the study
At baseline and at each follow-up visit patients will undergo the following assessments ophthalmic examination best-corrected visual acuity color fundus photography and fluorescein angiography Indocyanine green ICG angiography will be conducted at baseline Month 12 and Month 24 Optical coherence tomography OCT will be done at baseline Month 3 Month 6 Month 12 and Month 24 Adverse events and concomitant medications will be assessed throughout the study
Study Oversight
Has Oversight DMC:
None
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?:
None