Age-Related Macular Degeneration Clinical Trial
Official title:
A Prospective, Single-Blind, Randomized Study to Evaluate Intravitreal Aflibercept Injection (IAI) Versus Sham as PROphylaxis Against CONversion to Neovascular Age-Related Macular Degeneration (AMD) in High-Risk Eyes
This is a prospective, single-blind, randomized study to evaluate intravitreal aflibercept injection (IAI) versus sham as prophylaxis against conversion to neovascular age-related macular degeneration (AMD) in "high-risk" subjects.
128 subjects will be enrolled in the trial and randomized in a 1:1 ratio to receive either
IAI every three months for 24 months or sham injections. Enrollment will be stratified in
order to ensure a balance between the two treatment groups for subjects who were diagnosed
with exudative AMD within the past two years versus those diagnosed more than two years
prior to Baseline.
Study assessments will be conducted at required visits every three months and include
manifest refraction and ETDRS visual acuity testing, slit lamp exam and dilated fundus exam,
spectral-domain optical coherence tomography (SD-OCT) using Avanti device, and OCT
angiography using Avanti AngioVueTM, and fluorescein angiography. Fundus photography will
also be performed at Baseline, Month 12 and Month 24 visits.
In the event of conversion to neovascular AMD in the study eye at any point during the
study, the Investigator will treat the subject with IAI at a frequency per his/her
discretion.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention
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