TAC-PF, Avastin® in Combination With Photodynamic Therapy to Treat Age Related Macular Degeneration

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Age-Related Macular Degeneration

Intervention / Treatment
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* Drug: Avastin
* Procedure: Photodynamic Therapy (PDT)
* Drug: Preservative-Free Triamcinolone Acetonide (TAC-PF)


Participation Criteria
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Eligibility Criteria
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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 Exclusion Criteria Geographic atrophy or fibrosis under the fovea Fibrosis, hemorrhage, pigment epithelial detachments and other hypofluorescent lesions obscuring more than 50% of total lesion Prior treatment with verteporfin within 12 months IOP is >25 mmHg and the participant is on Cosopt Intraocular surgery within 6 weeks Prior vitrectomy Peribulbar steroid injection within 6 months Poor reactions to topical or periocular steroid treatment including elevated IOP

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Avastin|nan|
|Procedure: Photodynamic Therapy (PDT)|nan|
|Drug: Preservative-Free Triamcinolone Acetonide (TAC-PF)|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The mean change in best-corrected ETDRS visual acuity in the study eye from baseline to month 12 |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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AMD, wet AMD, verteporfin PDT, Avastin, TAC-PF