Ignite Creation Date:
2024-05-05 @ 5:17 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00423189
Status:
TERMINATED
Last Update Posted:
2016-03-04
First Post:
2007-01-16
Brief Title:
Lucentis Utilizing Visudyne LUV Trial Combination Therapy in the Treatment of Age-Related Macular Degeneration
Sponsor:
David M Brown MD
Organization:
Greater Houston Retina Research
Study Overview
Official Title:
Lucentis Utilizing Visudyne LUV Trial-- Reduced Fluence Photodynamic Therapy With Visudyne Combined With Intravitreal Ranibizumab in the Treatment of Age-Related Macular Degeneration
Status:
TERMINATED
Status Verified Date:
2016-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Lack of efficacy
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The PDTLucentis trial will be a Phase IV comparative trial comparing the use of combination therapy with ITV ranibizumab and verteporfin PDT to ITV ranibizumab alone in patients with exudative AMD
Detailed Description:
The PDTLucentis trial will be a Phase IV comparative trial comparing the use of combination therapy with ITV ranibizumab and verteporfin PDT to ITV ranibizumab alone in patients with exudative AMD Patients will be randomized to one of three groups All patients will receive three consecutive monthly treatments with ITV ranibizumab Patients randomized to group I will receive only ITV ranibizumab Patients randomized to group II will also receive one treatment with reduced fluence 20 fluence verteporfin PDT at day 0 Patients randomized to group III will also receive one treatment with reduced fluence 40 fluence vPDT All patients will also be evaluated for possible retreatment with ranibizumab according to established criteria Thirty patients ten per group will be recruited from one US sites in a 6-month period Randomization will occur at the time of entry into the study Follow-up will continue until month 12 from day 0 in all subjects
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