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Aflibercept (EYLEA®) induces a rapid reduction in central retinal thickness (CRT) for patients suffering from neovascular age-related-macular degeneration.1 This early dramatic reduction in CRT is already observed through week 4. Therefore it might be not necessary to consistently perform each of the three monthly consecutive intravitreal injections of the so-called loading phase.
The aim of this study is to assess whether the retina of some patients has dried up after the first or second intravitreal injection of Aflibercept (EYLEA®) 2mg and in that event, to determine the proportion of these patients The analysis of the characteristics could help identify a morphotype that would predict whether and when the retina will dry up within the first 3 months of treatment. For some patients having an early drying-up, the third monthly injection might be not necessary 50 naïve patients will be included and will receive a monthly injection over 12 weeks with a biweekly follow-up. Morphological and functional characteristics will be recorded at each visit and will be analyzed. The rate of patients with dry SD-OCT will be assessed.
The study includes 7 visits. The visits are scheduled on an every 2-week basis from baseline to Week 12. V1 (baseline), V3 and V5, the patient will be injected with Aflibercept (EYLEA®) 2mg. In the other visits, the visual acuity test, Fundus photography, SD-OCT, and/or Fluorescein Angiography are performed
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aflibercept 2mg Intravitreal injection | Other | 2 mg intravitreal Aflibercept initiated with one injection every 4 weeks for three consecutive doses (loading dose) The duration of the follow-up is 12 weeks. This means 3 injections per patient should be given over the study period |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intravitreal injection | Procedure | 2 mg intravitreal Aflibercept initiated with one injection every 4 weeks for three consecutive doses (loading dose) The duration of the follow-up is 12 weeks. This means 3 injections per patient should be given over the study period |
| Measure | Description | Time Frame |
|---|---|---|
| Occurence of a Dry SD-OCT 12-week after initiation of a treatment by Aflibercept (EYLEA®) 2mg | 12-week after initiation of a treatment by Aflibercept (EYLEA®) 2mg |
| Measure | Description | Time Frame |
|---|---|---|
| Time to get a dry SD-OCT after initiation of a treatment by Aflibercept | Every 2 weeks from treatment initiation (inclusion) to week 12 | |
| Evolution of morphological and visual modification under Aflibercept (EYLEA®) | Every 2 weeks from treatment initiation (inclusion) to week 12 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jean-François KOROBELNIK, Professor | University Hospital Bordeaux, France | Principal Investigator |
| Geneviève CHENE, MDPhD | University Hospital Bordeaux, France | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Service d'ophtalmologie Hôpital Henri Mondor 40, avenue de Verdun | Créteil | 94000 | France | |||
| Service Ophtalmologie CHU DIJON 14 rue Gaffarel BP 77908 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23558214 | Background | Patel KH, Chow CC, Rathod R, Mieler WF, Lim JI, Ulanski LJ 2nd, Leiderman YI, Arun V, Chau FY. Rapid response of retinal pigment epithelial detachments to intravitreal aflibercept in neovascular age-related macular degeneration refractory to bevacizumab and ranibizumab. Eye (Lond). 2013 May;27(5):663-7; quiz 668. doi: 10.1038/eye.2013.31. Epub 2013 Apr 5. | |
| 18088159 |
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| Occurence of pigment epithelial detachment | Every 2 weeks from treatment initiation (inclusion) to week 12 |
| Evolution of retinal hemorrhage if any | Every 2 weeks from treatment initiation (inclusion) to week 12 |
| Evolution in the atrophic lesions | Every 2 weeks from treatment initiation (inclusion) to week 12 |
| Occurence the central Retinal Thickness | Every 2 weeks from treatment initiation (inclusion) to week 12 |
| Dijon |
| 21079 |
| France |
| Service d'Ophtalmologie Hôpital de la croix rousse | Lyon | 69317 | France |
| Cabinet d'ophtalmologie 1 rue Pougin de la Maisonneuve | Montargis | 45200 | France |
| Sce Ophtalmologie CHU Nantes 1 place Alexis Ricordeau | Nantes | 44093 | France |
| Centre ophtalmique d'imagerie et de laser (CIL) 11 rue Antoine Bourdelle | Paris | 75011 | France |
| Sce du Pr SAHEL Fondation ROTHSCHILD 25 rue Manin | Paris | 75019 | France |
| Sce Ophtalmologie Hôpital Lariboisière 2 rue Ambroise Paré | Paris | 75475 | France |
| Service Opthalmo 2 Clinique Mathilde 4 rue de Lessard | Rouen | 76100 | France |
| Centre Ophtalmologie Transparence 30 Boulevard Heurteloup | Tours | 37000 | France |
| Cruess AF, Zlateva G, Xu X, Soubrane G, Pauleikhoff D, Lotery A, Mones J, Buggage R, Schaefer C, Knight T, Goss TF. Economic burden of bilateral neovascular age-related macular degeneration: multi-country observational study. Pharmacoeconomics. 2008;26(1):57-73. doi: 10.2165/00019053-200826010-00006. |
| 17021318 | Background | Rosenfeld PJ, Brown DM, Heier JS, Boyer DS, Kaiser PK, Chung CY, Kim RY; MARINA Study Group. Ranibizumab for neovascular age-related macular degeneration. N Engl J Med. 2006 Oct 5;355(14):1419-31. doi: 10.1056/NEJMoa054481. |
| 21057805 | Background | Cohen SY, Souied EH, Weber M, Dupeyron G, de Pouvourville G, Lievre M, Ponthieux A. Patient characteristics and treatment of neovascular age-related macular degeneration in France: the LUEUR1 observational study. Graefes Arch Clin Exp Ophthalmol. 2011 Apr;249(4):521-7. doi: 10.1007/s00417-010-1553-0. Epub 2010 Nov 6. |
| 21640258 | Background | Heier JS, Boyer D, Nguyen QD, Marcus D, Roth DB, Yancopoulos G, Stahl N, Ingerman A, Vitti R, Berliner AJ, Yang K, Brown DM; CLEAR-IT 2 Investigators. The 1-year results of CLEAR-IT 2, a phase 2 study of vascular endothelial growth factor trap-eye dosed as-needed after 12-week fixed dosing. Ophthalmology. 2011 Jun;118(6):1098-106. doi: 10.1016/j.ophtha.2011.03.020. |
| 33600134 | Derived | Korobelnik JF, Souied EH, Oubraham H, Razavi S, Mauget-Faysse M, Savel H, Chene G, Wolf S. ASSESSMENT OF EARLY CHANGES IN SPECTRAL DOMAIN-OPTICAL COHERENCE TOMOGRAPHY AFTER INITIATION OF TREATMENT WITH INTRAVITREAL AFLIBERCEPT (EYLEA) OVER A 12-WEEK PERIOD FOR PATIENTS WITH NEOVASCULAR AGE-RELATED MACULAR DEGENERATION: A Multicenter French Study (START). Retina. 2021 Mar 1;41(3):588-594. doi: 10.1097/IAE.0000000000002910. |
| ID | Term |
|---|---|
| D058449 | Intravitreal Injections |
| ID | Term |
|---|---|
| D056965 | Injections, Intraocular |
| D007267 | Injections |
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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