Neovascular Age-related Macular Degeneration of All Subtypes Clinical Trial
Official 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.
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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Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment