Age-Related Macular Degeneration
Conditions
Keywords
AMD, wet AMD, verteporfin PDT, Avastin, TAC-PF
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.
Interventions
DRUGAvastin
PROCEDUREPhotodynamic Therapy (PDT)
DRUGPreservative-Free Triamcinolone Acetonide (TAC-PF)
Sponsors
QLT Inc.
National Eye Institute (NEI)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Includes: * Drusen \> 63 mm * Choroidal neovascularization under the fovea (Predominantly Classic, Minimally Classic, and Occult lesions acceptable) * Greatest linear dimension (GLD) of entire lesion \< 5400 µm (no reading center confirmation required) * ETDRS best corrected visual acuity of 20/40 - 20/320 (73 - 24 letter score) * Total area of lesion must \< 9 MPS DA * 0-3 intravitreal injections of anti-VEGF monotherapy within 6 months of randomization with continuing evidence of exudative activity confirmed by FA or OCT within 4-8 weeks after the last injection
Exclusion criteria
Includes: * Oral steroid use within 6 months * Prior complications from steroid therapy * Prior stroke, myocardial infarction, or end-stage malignancy Study Eye
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The mean change in best-corrected ETDRS visual acuity in the study eye from baseline to month 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
| 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. | — |
| Mean and median change in ETDRS BCVA from baseline to months 3, 6, and 24. | — |
| Proportion of participants who show any improvement in ETDRS BCVA 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. | — |
| Mean change in area of leakage (Disc Areas) at months 3, 6, 12, and 24. | — |
Countries
United States
Outcome results
None listed