Ignite Creation Date:
2024-05-05 @ 5:13 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00413829
Status:
COMPLETED
Last Update Posted:
2010-01-14
First Post:
2006-12-19
Brief Title:
Immediate Effects of Lucentis in Conjunction With Photodynamic Therapy With Visudyne in Exudative AMDIECOMB
Sponsor:
Insel Gruppe AG University Hospital Bern
Organization:
Insel Gruppe AG University Hospital Bern
Study Overview
Official Title:
Open-label Phase II Study Assessing Immediate Effects of LucentisRanibizumab Administered in Conjunction With Photodynamic Therapy With Visudyne in Patients With Choroidal Neovascularization Secondary to AMD
Status:
COMPLETED
Status Verified Date:
2010-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is an evaluation of the short term effects on CNV perfusion of a same-day administration of photodynamic therapy PDT with Visudyne and an intravitreal injection of Lucentis ranibizumab 03 mg An evaluation of the short term effects on CNV perfusion of this combined treatment is needed for better understanding of treatment effects
Detailed Description:
The primary objective is to quantify the short term effects on CNV perfusion of the same-day administration of photodynamic therapy with Visudyne and an intravitreal injection of ranibizumab These short term effects will be assessed with visual acuity measurements and ophthalmic examinations including indocyanine green ICG and fluorescein angiography FA as well as Optical Coherence Tomography OCT measurements The primary variable for this assessment is the incidence of CNV closure one week after combined therapy as assessed with high speed ICG angiography Fluorescein and ICG angiography will be performed using a scanning laser ophthalmoscope HRA All angiographic studies and OCT examinations will be evaluated by the Bern Photographic Reading Center in a masked fashion Visual acuity assessments will be performed with Early Treatment Diabetic Retinopathy Study ETDRS-like visual acuity testing charts
A secondary objective is to explore the effect of the same-day administration of photodynamic therapy with Visudyne and an intravitreal injection of ranibizumab
on retinal thickness as measured by OCT over time
in change of total lesion area area of CNV assessed by FA
in mean change of VA from baseline over time
A secondary objective is to explore the effect of the same-day administration of photodynamic therapy with Visudyne and an intravitreal injection of ranibizumab
on retinal thickness as measured by OCT over time
in change of total lesion area area of CNV assessed by FA
in mean change of VA from baseline over time
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