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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-002869-19 | EudraCT Number |
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| Name | Class |
|---|---|
| Bayer | INDUSTRY |
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The purpose of the current study is to evaluate the ability of Eylea to induce a regression of PED height on patients previously extensively treated by Lucentis.
The regimen proposed for this study is the 3 monthly injection followed by a 6 weeks interval injection until week 26.
The regimen proposed for this study is the 3 monthly injection followed by a 6 weeks interval injection until week 26.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aflibercept | Experimental | Patients will receive 2 mg of aflibercept by intravitreal injection every 4 weeks until week 8, followed by every 6 weeks to week 26 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aflibercept | Drug | Intravitreal Injection |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in maximal height of pigment epithelium detachment (PED) at 12 weeks | Baseline and 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in central retinal thickness by SD OCT at 12 weeks | Baseline and 12 weeks | |
| Change from Baseline in visual acuity at 12 weeks | Baseline and 12 weeks | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eric Souied, MD | Centre Hospitalier Intersommunal de Créteil | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Pellegrin | Bordeaux | 33000 | France | |||
| Centre Hospitalier Intercommunal de Créteil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30681643 | Derived | Mouallem-Beziere A, Blanco-Garavito R, Richard F, Miere A, Jung C, Rozet JM, Souied EH. GENETICS OF LARGE PIGMENT EPITHELIAL DETACHMENTS IN NEOVASCULAR AGE-RELATED MACULAR DEGENERATION. Retina. 2020 Apr;40(4):663-671. doi: 10.1097/IAE.0000000000002454. |
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| Change from Baseline in volume of pigment epithelium detachment at 12 weeks |
| Baseline and 12 weeks |
| Association with genes involved in AMD history | genetic testing will be performed when all the particpitants will be recruited |
| Number of participants with adverse events from baseline to 32 weeks | from baseline to 32 weeks |
| Change from Baseline in pigment epithelium detachment height at 12 weeks | Baseline and 12 weeks |
| Change from baseline in central retinal thickness at 32 weeks | baseline and 32 weeks |
| Change from Baseline in pigment epithelium detachment height at 32 weeks | Baseline and 32 weeks |
| Change from Baseline in visual acuity at 32 weeks | Baseline and 32 weeks |
| Change from Baseline in volume of pigment epithelium detachment at 32 weeks | Baseline and 32 weeks |
| Créteil |
| 94010 |
| France |
| Hôpital général de Dijon | Dijon | 21033 | France |
| Centre d'Ophtalmologie Rabelais | Lyon | 69003 | France |
| Cabinet Alpes Rétine | Montbonnot-Saint-Martin | 38330 | France |
| CHR Hôtel Dieu | Nantes | 44093 | France |
| Centre d'explorations ophtalmologiques de l'odéon | Paris | 75006 | France |
| Hôpital des Quinze-Vingts | Paris | 75012 | France |
| Clinique Mathilde | Rouen | 76100 | France |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jun 17, 2026 |
| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| D057135 | Wet Macular Degeneration |
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
| D014786 | Vision Disorders |
| D001766 | Blindness |
| ID | Term |
|---|---|
| D015785 | Eye Diseases, Hereditary |
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C533178 | aflibercept |
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