Ignite Creation Date:
2024-05-05 @ 5:30 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00464347
Status:
TERMINATED
Last Update Posted:
2010-03-24
First Post:
2007-04-19
Brief Title:
TAC-PF Avastin in Combination With Photodynamic Therapy to Treat Age Related Macular Degeneration
Sponsor:
National Eye Institute NEI
Organization:
National Eye Institute NEI
Study Overview
Official Title:
Multi-Center Randomized Phase II Clinical Trial to Study the Effects of Preservative-Free Triamcinolone Acetonide and Avastin in Combination With Photodynamic Therapy in Participants With Neovascular Age Related Macular Degeneration
Status:
TERMINATED
Status Verified Date:
2007-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study was terminated because of poor enrollment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
VERTACL
Brief Summary:
VERTACL will investigate whether a triple therapy Avastin half fluence verteporfin photodynamic therapy PDT and triamcinolone acetonide-preservative free TAC- PF results in improved 12-month vision outcome compared to Avastin alone in participants with neovascular AMD
Detailed Description:
The VERTACL study is a multi-center randomized Phase II trial to investigate whether a triple therapy Avastin half fluence verteporfin PDT and TAC- PF results in improved 12-month vision outcome compared to Avastin alone in participants with neovascular AMD
Participants will be randomized similar to the flip of a coin in a 11 ratio to one of the two study groups single therapy Avastin or triple therapy Avastin half fluence verteporfin PDT and TAC- PF Participants in the Avastin alone arm will receive 125 mg intravitreal Avastin at every study visit Participants in the triple-therapy arm will receive all treatments Avastin half fluence verteporfin PDT and TAC- PF at baseline
Following baseline participants in the triple therapy study arm will receive study treatment on an as-needed PRN basis if protocol-specific re-treatment criteria are met After randomization participants will return to the clinic approximately every six weeks for one year for study assessments and possible re-treatment
Participants will return to the clinic at month 24 for a final study assessment Study assessments include visual acuity optical coherence tomography and fundus photography
Participants will be randomized similar to the flip of a coin in a 11 ratio to one of the two study groups single therapy Avastin or triple therapy Avastin half fluence verteporfin PDT and TAC- PF Participants in the Avastin alone arm will receive 125 mg intravitreal Avastin at every study visit Participants in the triple-therapy arm will receive all treatments Avastin half fluence verteporfin PDT and TAC- PF at baseline
Following baseline participants in the triple therapy study arm will receive study treatment on an as-needed PRN basis if protocol-specific re-treatment criteria are met After randomization participants will return to the clinic approximately every six weeks for one year for study assessments and possible re-treatment
Participants will return to the clinic at month 24 for a final study assessment Study assessments include visual acuity optical coherence tomography and fundus photography
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