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| ID | Type | Description | Link |
|---|---|---|---|
| EY1413FR | Other Identifier | company internal |
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| Name | Class |
|---|---|
| Regeneron Pharmaceuticals | INDUSTRY |
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The aim of the TITAN study is to describe the clinical practices of a cohort of patients with wAMD refractory to ranibizumab (persistence of intra-retinal and/or subretinal fluid) who switch to aflibercept after less than 12 months of ranibizumab treatment.
The study will be conducted in real-life conditions and will allow describing conditions of use of aflibercept in patients refractory to ranibizumab
The study is both retrsopective and prospective to collect local real life data on patients under routine treatment.
The observation periods starts on January 2014. Patients who initiated a treatment by Aflibercept between the 1st of january 2014 and the 31 December 2015 will be enrolled.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | According to the recommendations of the Summary of Products Characteristics (SmPC) Administration by intravitreal injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aflibercept (EYLEA, BAY-86-5321) | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Treatment success rate (defined as a gain of at least 1 letter in BCVA and/or a diminution of CRT (expressed in µm)) | The 12 month follow up visit is the visit 12 month after the first injection of aflibercept | Between initial visit and 12 month follow up visit |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients whose BCVA increases by ≥ 0 letter, ≥ 5 letters, ≥ 10 letters, ≥15 letters | The end of study visit is the visit 12 month after the first injection of aflibercept or after last follow up visit when the patient drop out the study whichever apply.. | Between initial visit and up to 1 year maximum |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with a diagnosis of wAMD refractory to ranibizumab (persistence of fluid) who started a treatment with Anti VEGF (Aflibercept) may be included in the study
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Multiple Locations | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33596867 | Derived | Razavi S, Kodjikian L, Giocanti-Auregan A, Dufour I, Souied E. Efficacy and safety of intravitreal aflibercept in ranibizumab-refractory patients with neovascular age-related macular degeneration. BMC Ophthalmol. 2021 Feb 17;21(1):90. doi: 10.1186/s12886-021-01841-6. |
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| ID | Term |
|---|---|
| D057135 | Wet Macular Degeneration |
| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| C533178 | aflibercept |
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| Proportion of patients with less than 15 letters loss |
| Between initial visit and up to 1 year maximum |
| Proportion of patients with dry-OCT | Between initial visit and up to 1 year maximum |
| Mean duration of treatment with ranibizumab before initiation of aflibercept | Between initial visit and up to 1 year maximum |
| Mean change in Central retinal thickness in µm (OCT) | Between initial visit and up to 1 year maximum |