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| Name | Class |
|---|---|
| Bayer | INDUSTRY |
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This study is a randomized, prospective, exploratory, descriptive, open label, parallel group, post-authorization study designed to describe and evaluate two aflibercept treatment regimens aimed at achieving and maintaining a maximum visual function benefit (i.e., BCVA stability). The goal of the study is to compare two strategies for dosing regimen with aflibercept in wet AMD: the standard regimen (one injection every 8 weeks after 3 monthly loading doses in the treatment of wet age-related macular degeneration) versus the treat and extend protocol (details outlined below in the "Study Design" section) aiming at achieving and maintaining maximum visual acuity benefit while minimizing the number of injections. Patients will be randomized at week 8 (Month 2) in a proportion of 1:2 (Standard treatment : treat and extend treatment). We aim to demonstrate that the Treat and Extend regimen is equivalent or better to the standard fixed interval regimen in terms of change in patients' visual acuity after a year of treatment and that patients in the Treat and Extend arm will receive fewer injections and fewer visits, than their counterparts in the standard regimen arm. The results could be used to generate a base for future controlled-randomized clinical trials on the timing of treatment administration for patients with wAMD.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard | Active Comparator | 2 ml (40 mg/ml) of Eylea solution : loading dose of 3 intravitreal injections every 4 weeks for the first 3 months followed by an injection every 8 weeks until the end of the study |
|
| Treat and Extend | Experimental | 2 ml (40 mg/ml) of Eylea solution : loading dose of 3 intravitreal injections every 4 weeks for the first 3 months followed and, until the end of the study, retreatment interval based on disease stability |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aflibercept | Drug | Intraocular injection of 2 ml (40mg/ml) |
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| Measure | Description | Time Frame |
|---|---|---|
| Best Corrected Visual Acuity | Change in BCVA as measured in with an ETDRS chart | from baseline to week 52 (Month 12) |
| Injections | Number of injections | from baseline to week 52 (Month 12) |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment-free intervals | Treatment frequency and duration of treatment-free intervals applied in the treat and extend dosing regimen arm | from baseline to week 52 (Month 12) |
| Gain of letters | Proportion of patients with gain of 5 or more, 10 or more, and 15 or more letters |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GOGIUNTA | Sherbrooke | Quebec | J1G 2V4 | Canada |
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| ID | Term |
|---|---|
| C533178 | aflibercept |
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| from baseline to week 52 (Month 12) |
| Loss of letters | Proportion of patients with loss of 5 or more, 10 or more, and 15 or more letters | from baseline to week 52 (Month 12) |