TAC-PF, Avastin® in Combination With Photodynamic Therapy to Treat Age Related Macular Degeneration (VERTACL)
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.
Age-Related Macular Degeneration
Procedure: Photodynamic Therapy (PDT)
Drug: Preservative-Free Triamcinolone Acetonide (TAC-PF)
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
|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|
- The mean change in best-corrected ETDRS visual acuity in the study eye from baseline to month 12
- Mean and median change in ETDRS BCVA from baseline to months 3, 6, and 24.
- Proportion of participants avoiding a loss of ³ 15 letters in ETDRS BCVA by months 3, 6, 12, and 24
- Proportion of participants improving by ³ 15 letters in ETDRS BCVA at months 3, 6, 12, and 24.
- Proportion of participants who show any improvement in ETDRS BCVA at months 3, 6, 12, and 24.
- Mean change in the total lesion area (Disc Areas) from baseline to months 3, 6, 12, and 24.
- Mean change in area of CNV (Disc Areas) at months 3, 6, 12, and 24.
- Mean change in area of leakage (Disc Areas) at months 3, 6, 12, and 24.
- Proportion of classic CNV out of the entire lesion from baseline to months 3, 6, 12, and 24.
- Changes in mean excess retinal thickening in the center subfield (i.e., thickness >175 microns) from baseline to months 3, 6, 12, and 24.
- Proportion of participants with reduction in retinal thickening in the center subfield (i.e., thickness > 175 microns) of ³50% and of at least 50 microns from baseline to months 3, 6, 12, and 24.
- The overall probability of re-injection (excluding injections precluded for safety concerns) through Month 12.
- The mean number of injections by quarter on study following initial induction injections.
|Study Start Date:||January 2007|
|Study Completion Date:||September 2007|
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 1:1 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 1.25 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.
|United States, Florida|
|Retinal Group of Florida|
|Ft. Lauderdale, Florida, United States, 33334|
|Central Florida Retina- Orlando|
|Orlando, Florida, United States, 32746|
|Pensacola, Florida, United States, 32503|
|United States, Maryland|
|Elman Retina Group- Baltimore|
|Baltimore, Maryland, United States, 21237|
|United States, Michigan|
|Associated Retinal Consulants|
|Grand Rapids, Michigan, United States, 49546|
|United States, Minnesota|
|Minneapolis, Minnesota, United States, 55435|
|United States, North Carolina|
|Duke University Eye Center|
|Durham, North Carolina, United States, 27710|
|United States, South Carolina|
|Palmetto Retina Center|
|Columbia, South Carolina, United States, 29204|
|United States, Tennessee|
|Southeastern Retina Associates|
|Knoxville, Tennessee, United States, 37909|
|United States, Texas|
|Texas Retina Associates-Arlington|
|Arlington, Texas, United States, 76012|
|Texas Retina Associates-Dallas|
|Dallas, Texas, United States, 85231|
|Study Chair:||Karl G Csaky, MD, PhD||Duke University|