Ignite Creation Date:
2024-05-05 @ 5:30 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00473642
Status:
COMPLETED
Last Update Posted:
2020-11-06
First Post:
2007-05-14
Brief Title:
Reduced Fluence Photodynamic Therapy PDT With Visudyne in Combination With Lucentis for Age-Related Macular Degeneration
Sponsor:
Oklahoma State University Center for Health Sciences
Organization:
Oklahoma State University Center for Health Sciences
Study Overview
Official Title:
A Prospective Pilot Study of Reduced Fluence Photodynamic Therapy With Visudyne Verteporfin in Combination With Lucentis Ranibizumab for the Treatment of Age-Related Macular Degeneration
Status:
COMPLETED
Status Verified Date:
2020-11
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:
In this pilot study the researchers will evaluate the safety and efficacy of 50 reduced fluence PDT combination therapy with ranibizumab The researchers hope to gain information regarding the use of reduced fluence PDT combination therapy The information gained from this pilot study may prompt further definitive studies comparing the safety and efficacy of both standard fluence PDT combination therapy reduced fluence PDT combination therapy and ranibizumab monotherapy
The study will compare the use of combination therapy with ranibizumab and verteporfin PDT to ranibizumab alone in patients with exudative age-related macular degeneration AMD All patients will receive three consecutive monthly treatments with ranibizumab Patients will be randomized 111 to 3 groups Patients randomized to group 1 will receive only ranibizumab Patients randomized to group 2 will also receive one treatment with reduced fluence 50 fluence verteporfin PDT at day 0 Patients randomized to group 3 will also receive one treatment with standard fluence verteporfin PDT All patients will also be evaluated for possible retreatment with ranibizumab and verteporfin PDT according to established criteria Thirty patients will be recruited from one US sites Randomization will occur at the time of entry into the study Follow-up will continue until month 12 from day 0 in all subjects
The study will compare the use of combination therapy with ranibizumab and verteporfin PDT to ranibizumab alone in patients with exudative age-related macular degeneration AMD All patients will receive three consecutive monthly treatments with ranibizumab Patients will be randomized 111 to 3 groups Patients randomized to group 1 will receive only ranibizumab Patients randomized to group 2 will also receive one treatment with reduced fluence 50 fluence verteporfin PDT at day 0 Patients randomized to group 3 will also receive one treatment with standard fluence verteporfin PDT All patients will also be evaluated for possible retreatment with ranibizumab and verteporfin PDT according to established criteria Thirty patients will be recruited from one US sites Randomization will occur at the time of entry into the study Follow-up will continue until month 12 from day 0 in all subjects
Detailed Description:
None
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