TAC-PF, Avastin® in Combination With Photodynamic Therapy to Treat Age Related Macular Degeneration
- Conditions
- Age-Related Macular Degeneration
- Registration Number
- NCT00464347
- Lead Sponsor
- National Eye Institute (NEI)
- 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 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 100
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method The mean change in best-corrected ETDRS visual acuity in the study eye from baseline to month 12
- Secondary Outcome Measures
Name Time Method 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.
Trial Locations
- Locations (11)
Duke University Eye Center
🇺🇸Durham, North Carolina, United States
VitroRetinal Surgery
🇺🇸Minneapolis, Minnesota, United States
Palmetto Retina Center
🇺🇸Columbia, South Carolina, United States
Retina Specialists
🇺🇸Pensacola, Florida, United States
Southeastern Retina Associates
🇺🇸Knoxville, Tennessee, United States
Texas Retina Associates-Arlington
🇺🇸Arlington, Texas, United States
Central Florida Retina- Orlando
🇺🇸Orlando, Florida, United States
Elman Retina Group- Baltimore
🇺🇸Baltimore, Maryland, United States
Associated Retinal Consulants
🇺🇸Grand Rapids, Michigan, United States
Texas Retina Associates-Dallas
🇺🇸Dallas, Texas, United States
Retinal Group of Florida
🇺🇸Ft. Lauderdale, Florida, United States