Fibrovascular Pigment Epithelial Detachment Clinical Trial
Official title:
This is an Open Label Study to Evaluate the Efficacy of Intravitreal Aflibercept Injection 2mg in Patients With a Persistent FVPED Despite at Least 6 Consecutive Injections With Ranibizumab 0.5 mg
This is an open label study to evaluate the efficacy of intravitreal aflibercept injection 2mg in patients with a persistent FVPED despite at least 6 consecutive injections with ranibizumab 0.5 mg.
This is an open label study to evaluate the efficacy of intravitreal aflibercept injection
2mg in patients with a persistent FVPED despite at least 6 consecutive injections with
ranibizumab 0.5 mg.
Patients being evaluated at VRM New York with neovascular AMD who have persistent sub-foveal
FVPED on OCT despite at least 6 consecutive ranibizumab injections will be considered for the
study.
We aim to recruit 25 patients in the study. There have been no statistical tests to calculate
sample size; sample size of 25 patients is chosen, making sure that it is feasible
financially to conduct the study and logistically to complete the study within 24 weeks. This
is a pilot study to assess the effects of intravitreal aflibercept injection on chronic,
persistent FVPEDs; currently there is no data regarding visual and anatomical outcomes for
this group of patients.
Patients will be reviewed at baseline and then at 4 week intervals (28 ± 7 days). They will
receive intravitreal intravitreal aflibercept injection 2mg at each visit. The primary end
point of the study is 24 weeks from baseline. Patients who complete the study will have
received 6 injections of intravitreal aflibercept injection 2mg.
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