Neovascular Age-related Macular Degeneration of All Subtypes Clinical Trial
— STARTOfficial title:
Assessment of Early Changes in SD-OCT After Initiation of a Treatment by Intravitreal Aflibercept (EYLEA®) (2mg) Over a 12-week Period for Patients Suffering From Neovascular Age-related Macular Degeneration (AMD) French SD OCT in wAMD
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.
| Status | Completed |
| Enrollment | 50 |
| Est. completion date | June 2015 |
| Est. primary completion date | June 2015 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 50 Years and older |
| Eligibility |
Inclusion Criteria: - Men and women = 50 years of age - Active primary subfoveal choroidal neovascularization (CNV) lesions secondary to AMD including juxtafoveal lesions that affects the fovea as evidenced by FA in the study eye - Signed Informed Consent - Willing, committed, and able to return for ALL clinic visits and complete all study-related procedures. Exclusion Criteria: - Prior treatment with anti-VEGF therapy in the study eye - Active or suspected ocular or periocular infection. - Active severe intraocular inflammation |
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| France | Service d'ophtalmologie Hôpital Henri Mondor 40, avenue de Verdun | Creteil | |
| France | Service Ophtalmologie CHU DIJON 14 rue Gaffarel BP 77908 | Dijon | |
| France | Service d'Ophtalmologie Hôpital de la croix rousse | Lyon | |
| France | Cabinet d'ophtalmologie 1 rue Pougin de la Maisonneuve | Montargis | |
| France | Sce Ophtalmologie CHU Nantes 1 place Alexis Ricordeau | Nantes | |
| France | Centre ophtalmique d'imagerie et de laser (CIL) 11 rue Antoine Bourdelle | Paris | |
| France | Sce du Pr SAHEL Fondation ROTHSCHILD 25 rue Manin | Paris | |
| France | Sce Ophtalmologie Hôpital Lariboisière 2 rue Ambroise Paré | Paris | |
| France | Service Opthalmo 2 Clinique Mathilde 4 rue de Lessard | Rouen | |
| France | Centre Ophtalmologie Transparence 30 Boulevard Heurteloup | Tours |
| Lead Sponsor | Collaborator |
|---|---|
| University Hospital, Bordeaux |
France,
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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. — View Citation
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| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | No | |
| Secondary | Time to get a dry SD-OCT after initiation of a treatment by Aflibercept | Every 2 weeks from treatment initiation (inclusion) to week 12 | No | |
| Secondary | Evolution of morphological and visual modification under Aflibercept (EYLEA®) | Every 2 weeks from treatment initiation (inclusion) to week 12 | No | |
| Secondary | Occurence of pigment epithelial detachment | Every 2 weeks from treatment initiation (inclusion) to week 12 | No | |
| Secondary | Evolution of retinal hemorrhage if any | Every 2 weeks from treatment initiation (inclusion) to week 12 | No | |
| Secondary | Evolution in the atrophic lesions | Every 2 weeks from treatment initiation (inclusion) to week 12 | No | |
| Secondary | Occurence the central Retinal Thickness | Every 2 weeks from treatment initiation (inclusion) to week 12 | No |