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| ID | Type | Description | Link |
|---|---|---|---|
| EY1411FR | Other Identifier | Company Internal |
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| Name | Class |
|---|---|
| Regeneron Pharmaceuticals | INDUSTRY |
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The purpose of this study is to collect real-life data on patients with wet age related macular degeneration (AMD) for whom treatment with Eylea was initiated
The study is both retrospective and prospective to collect local real life data on patients under routine treatment. The observation period starts on January 2014. Patients who have received the 1st injection with Eylea from January 2014 will be enrolled.
Patients will be followed up for a period of 48 months or until it is no longer possible
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | According to the recommendations of the Summary of Product Characteristics (SmPC) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321) | Drug | Administration by intravitreal injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in the measurement of best-corrected visual acuity (BCVA) from baseline to 12 months. | As assessed by Early Treatment Diabetic Retinopathy Study (ETDRS) method or any visual logarithmic scale | Baseline to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Best Corrected Visual Acuity (BCVA) during the second year and until the fourth year of treatment versus the initial visit | Baseline to 2 year, 3 year, 4 year | |
| Percentage of patients who experienced a gain in BCVA, from initial visit to each follow-up visit (letter score of ≥ 0 letters, ≥ 5 letters, ≥ 10 letters, ≥ 15 letters) |
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Inclusion Criteria:
Exclusion Criteria:
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Naïve treatment patients with wet AMD who started a treatment with Anti VEGF (Vascular Endothelial Growth Factor) 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 |
|---|---|---|---|
| 36399178 | Result | Cohen SY, Dominguez M, Coscas F, Faure C, Baillif S, Oubraham H, Kodjikian L, Weber M; RAINBOW study investigators. Final 4-year results of the RAINBOW real-world study: intravitreal aflibercept dosing regimens in France in treatment-naive patients with neovascular age-related macular degeneration. Graefes Arch Clin Exp Ophthalmol. 2023 Apr;261(4):959-969. doi: 10.1007/s00417-022-05900-6. Epub 2022 Nov 18. | |
| 32518833 |
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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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| Baseline to 1 year, 2 year, 3 year, 4 year |
| Percentage of patients losing fewer than 15 letters from the initial visit visual acuity at each follow-up visit | Baseline to 1 year, 2 year, 3 year, 4 year |
| Derived |
| Weber M, Kodjikian L, Coscas F, Faure C, Aubry I, Dufour I, Cohen SY. Impact of intravitreal aflibercept dosing regimens in treatment-naive patients with neovascular age-related macular degeneration in routine clinical practice in France: results from the RAINBOW study. BMJ Open Ophthalmol. 2020 Apr 6;5(1):e000377. doi: 10.1136/bmjophth-2019-000377. eCollection 2020. |
| 32450838 | Derived | Weber M, Dominguez M, Coscas F, Faure C, Baillif S, Kodjikian L, Cohen SY. Impact of intravitreal aflibercept dosing regimens in treatment-naive patients with neovascular age-related macular degeneration: 2-year results of RAINBOW. BMC Ophthalmol. 2020 May 25;20(1):206. doi: 10.1186/s12886-020-01468-z. |
| 31179386 | Derived | Weber M, Velasque L, Coscas F, Faure C, Aubry I, Cohen SY; RAINBOW study investigators. Effectiveness and safety of intravitreal aflibercept in patients with wet age-related macular degeneration treated in routine clinical practices across France: 12-month outcomes of the RAINBOW study. BMJ Open Ophthalmol. 2019 Apr 9;4(1):e000109. doi: 10.1136/bmjophth-2017-000109. eCollection 2019. |